Policy AdvisorPolicyTikTok Source

Over-the-Counter (OTC) Medications Requirements

Captured: TikTok page date: Hash: 371ea23fec43

Creator TL;DR

AI-generated from the captured TikTok policy text. Verify against the TikTok source before acting.

TikTok Shop only allows eligible sellers to list certain OTC medications, and only if they meet federal/state/local law, FDA labeling, and any DEA rules. Many OTC products, ingredients, claims, packaging formats, and age-based products are restricted or prohibited. Toddler OTC has extra invite-only requirements and stricter rules.

Key points

  • Only eligible sellers may list OTC medications.
  • OTC listings must also comply with the Restricted Products Policy.
  • Follow applicable federal, state, and local laws, plus FDA labeling and DEA rules.
  • Toddler OTC is invite only and has additional requirements.
  • Eligible sellers must submit authentic, unmodified documents.
  • Cough Relief is limited to dextromethorphan-only products and is state-restricted.
  • Many ingredients and product types are prohibited, including controlled substances, CBD, homeopathic products, and most combination cough/cold products.
  • All OTC drug products must be sealed, tamper-evident, and new.
  • TikTok may remove listings or restrict selling access for violations.

Say / show

  • Eligible sellers must verify category qualification before listing OTC products.
  • Check whether the product is on TikTok’s permitted OTC list before publishing.
  • Use only authentic, original-format documents and certificates.
  • Confirm labels, Drug Facts, warnings, and package details are shown in the listing.
  • For Toddler OTC, follow the stricter toddler-specific rules when they differ from general OTC rules.
  • Verify state restrictions for dextromethorphan products before sale or shipment.
  • Review TikTok’s source page and current Restricted Products Policy before acting.

Do not say / show

  • Any OTC product can be listed if it is over-the-counter.
  • DXM cough products can be sold in any state.
  • Toddler OTC follows the same rules as general OTC.
  • Homeopathic, CBD, injectable, or drug-paraphernalia products are allowed.
  • FDA logo use or “FDA approved” claims are acceptable without proper basis.
  • Documents can be modified or submitted in non-original format.
  • Age-restricted drug products for children under four are freely permitted.

Violation risks

  • Listing without an active invitation or eligibility.
  • Submitting inaccurate, fraudulent, or modified documents.
  • Listing prohibited ingredients or product types.
  • Missing Drug Facts or required labeling in the listing.
  • Selling products without sealed, tamper-evident packaging.
  • Improper use of FDA logo or “FDA approved” claims.
  • Account Health deductions, listing removal, loss of selling access, and customer refunds.

Who it affects

  • Sellers
  • Resellers
  • Manufacturers
  • Toddler OTC invite-only vetted sellers
  • Sellers listing dextromethorphan cough products

Source notes

  • This summary is based only on the provided TikTok source text; verify against the TikTok page and related policies before taking action.
  • Some sections in the source reference additional details not included in the captured text; check the original TikTok page for the full requirements.
  • This policy states it is informational only and sellers remain responsible for compliance with applicable law.

Confidence: high · Model: gpt-5.4-mini · Prompt: creator-policy-summary-v1

Readable Policy Copy

Captured policy content rendered without TikTok navigation, scripts, tracking markup, or page chrome. Source: article-html.

Key Points:
  • To sell Over-the-Counter (OTC) Medications, you must meet eligibility requirements to offer products in the category. Contact your Account Manager (AM) to learn more.
  • All sellers must follow applicable federal, state, and local laws and regulations. Sellers must also adhere to Food and Drug Administration (FDA) labeling requirements and any relevant Drug Enforcement Administration (DEA) rules.
  • Toddler OTC Medications are a High Risk subcategory with additional requirements. See Toddler OTC Medications.
This document outlines the requirements for selling Over-the-Counter (OTC) Medications on TikTok Shop. These rules are in place to help sellers list products safely and maintain compliance. OTC Medications are also subject to our Restricted Products Policy. Sellers must check that they meet both this document and the Restricted Products Policy when listing OTC medications.
This policy applies to all sellers, resellers, and manufacturers of Over-the-Counter (OTC) Medications. OTC medications require sellers to meet additional eligibility requirements before listing or sale. Sellers will be notified if they become eligible.

Over-the-Counter (OTC) Medications

OTC (Over-the-Counter) Medications are products sold directly to consumers that do not require a prescription. They are FDA-regulated, carry a standardized Drug Facts label, and are intended for self-treatment of common, minor conditions like pain, allergies, colds, and heartburn.
For more information, see FDA's Over-the-Counter (OTC) | Nonprescription Drugs page.
Sellers who do not meet eligibility requirements are prohibited from listing or selling OTC medications.

Permitted OTC Medications

The following OTC medications are allowed to be sold on our platform by eligible sellers:
  • Pain Relief & Fever Reducers (Ingestible)
    • Acetaminophen
    • Ibuprofen
  • Digestive Relief
    • Antacids
    • Gas relief (simethicone)
  • Antifungals (Topical)
    • Athlete's foot treatments
    • Jock itch treatments
    • Nail fungus treatments
    • Yeast infection treatments
    • Thrush treatments
    • Dandruff treatments
    • Nasal antifungal treatments
  • Acne Treatments (Topical)
    • Topical formulations compliant with FDA OTC Monograph M006 and within approved ingredient concentrations
  • Cuts & Wounds
    • First aid ointments
    • Topical antiseptics (iodine content ≤ 2.2%)
    • Hydrogen peroxide products within FDA limits
    • Products that support healing for cuts and wounds
  • Topical Pain Relief
    • Joint or muscle pain relief rubs
    • Topical analgesics (lidocaine content ≤ 4%)
  • Anti-Itch / Hydrocortisone (Topical)
    • Hydrocortisone anti-itch creams and ointments
  • Cough Relief (Ingestible) — single active ingredient only
    • Dextromethorphan (DXM) — antitussive (cough suppressant), as the sole active ingredient
    • Permitted forms: syrup, oral liquid/solution, lozenge, tablet, or capsule.
    • Single-ingredient scope: a permitted cough product must contain dextromethorphan as its only active ingredient. Any product with more than one active ingredient (for example, DXM combined with guaifenesin, acetaminophen, a decongestant, an antihistamine, or any other active) is not permitted at this time. Dextromethorphan products are additionally subject to state and age requirements.
Any OTC product type not listed above is not eligible for listing. Allergy relief medications are not currently permitted in any age range.
Note: Products in the Pain Relief & Fever Reducers and Digestive Relief categories that are labeled or marketed for toddlers are subject to additional requirements. See Toddler OTC Medications section.

Prohibited OTC Medications and Ingredients

Certain products and ingredients are prohibited on TikTok Shop, including but not limited to those listed below. Listings that include these items may be removed, and sellers may be subject to enforcement actions.

Controlled Substances and DEA-Regulated Ingredients

  • Codeine and all Schedule I–V controlled substances
  • Dimethyltryptamine (DMT)
  • Gamma-hydroxybutyric acid (GHB)
  • Ketamine
  • Psilocybin and Psilocybe cubensis
  • Cocaine and coca leaves (all forms)
  • Tetrahydrocannabinol (THC) and cannabis-derived psychoactive products
  • Peyote and mescaline
  • 1,4-Butanediol (GHB analogue)
  • Poppy pods, poppy straw, poppy straw concentrate, and poppy tea
  • Multi-symptom cough-and-cold combination medications, decongestant products, and allergy relief medications
  • Dextromethorphan cough products when labeled, advertised, or otherwise marketed for use by children under 4 years of age.

DEA List I Chemicals (Scheduled Listed Chemical Products)

  • DEA List I chemicals include, but are not limited to: pseudoephedrine, ephedrine, and phenylpropanolamine (PPA).

Prescription Drugs and Unapproved New Drugs (Not Approved for OTC Sale)

These are prescription or unapproved new drugs, not controlled substances. Examples include but are not limited to:
  • Ergotamine (prescription drug; not a scheduled controlled substance)
  • GLP-1 (glucagon-like peptide-1) agonists (prescription drugs approved via NDA; not approved for OTC sale)

Other Restricted or Unapproved Substances

  • Examples include but are not limited to: Kratom, Salvia divinorum, Jimson weed, and Amanita muscaria and Panther amanitas

Concentration-Restricted Ingredients

Examples include but are not limited to:
  • Iodine: Above 2.2% concentration (including Lugol's Solution)
  • Lidocaine: Above 4% concentration
  • Hydrocortisone: Above 1% concentration (prescription only)
  • Diclofenac: Above 1% concentration (prescription only)
  • Ketoconazole: Above 1% concentration (prescription only)

Quantity-Restricted Ingredients

  • Loperamide – limited to ≤48 mg per package; capsule and tablet formats must be packaged in blister packs only
  • Dextromethorphan — limited to ≤900 mg per package, with a maximum of 2 units per order

Age-Restricted Drug Products

The following drug products are prohibited when labeled, advertised, or otherwise marketed for use by children under four years of age:
  • Antidiarrheal drug products
  • Topical anesthetic drug products
NOTE: Products containing loperamide or bismuth subsalicylate are prohibited in Toddler OTC at any quantity. See Toddler OTC Medications section.

Other Prohibited Products

  • Homeopathic products of any form (oral, topical, or ophthalmic)
  • Products containing cannabidiol (CBD)
  • Cannabis-derived terpenes, terpene products intended for inhalation or psychoactive use, and tobacco-infused terpenes
  • Terpenes, terpene sprays, and tobacco-infused terpenes
  • Products marketed for treating moles, seborrheic keratoses, or skin tags
  • Products marketed for treating molluscum
  • Injectable drug products
  • Products claiming psychoactive, hallucinogenic, or controlled-substance-mimicking effects
  • Products claiming to imitate anabolic steroids or prescription-only drugs
  • Products intended to defeat drug tests (e.g., synthetic urine or urine additives)
  • Drug paraphernalia (for example, bongs, pipes, vaporizers, pill presses, and encapsulating machines)

Products containing dextromethorphan (DXM)

Products containing dextromethorphan (DXM) are subject to state-level sales and shipping restrictions. Because the Cough Relief category is currently limited to dextromethorphan, the entire category is restricted to the following states:
Alabama, Arkansas, Connecticut, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Maine, Maryland, Massachusetts, Minnesota, Mississippi, Missouri, Montana, Nebraska, New Hampshire, New Mexico, North Carolina, North Dakota, Oklahoma, Rhode Island, South Carolina, South Dakota, Utah, Vermont, and Wyoming.
Cough products may not be listed for, sold to, or shipped to any state not on this list. This allowlist is subject to change. Sellers must accurately disclose the active ingredient (dextromethorphan) in the product listing.

Requirements To Sell OTC Medications

Eligible sellers will need to submit documents proving they are qualified to sell these products.
Detailed requirements are listed in the sections below. Open each section to view what is needed.
All documents, test reports, and certificates submitted to TikTok Shop must be authentic and provided in their original, unmodified format (for example, PDF, or JPEG). TikTok Shop reserves the right to request additional information to review product safety and qualifications at any time.

Documentation Requirements

Eligible sellers must submit the following documents as part of category qualification.

Regulatory Pathway Declaration

Sellers must declare whether each product is marketed under an FDA-approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA), or under an FDA OTC Drug Monograph. Supporting documentation is required for each product:
  • NDA/ANDA products: The NDA or ANDA application number, along with a screenshot from the FDA National Drug Code (NDC) Directory showing the product listing, approved application number, and marketing status.
  • OTC Monograph products: The National Drug Code (NDC), along with a screenshot from the FDA NDC Directory showing the product's OTC monograph listing.
Note: FDA Drug Listing and Facility Registration records may be submitted as screenshots or printouts from the applicable FDA database. These records are database entries and are not formal certificates issued by the FDA.
Note: A National Drug Code (NDC) is required for all OTC drug products under 21 CFR Part 207. Narrow exceptions (for example, certain compounded products) apply only where documented. NDC is not optional.

Product Safety Documentation

Manufacturers, importers, and repackers must provide:
  • Certificate of Analysis (COA) from a qualified laboratory covering identity, strength, quality, and purity
  • cGMP certificate (see cGMP Certificate below)
  • Regulatory Pathway Declaration (see above)
  • Where the product is subject to the Poison Prevention Packaging Act (PPPA), a child-resistant packaging compliance statement under 16 CFR Part 1700, documented within the COA or test report

cGMP Certificate

Manufacturers, importers, and repackers must provide documents showing they meet Current Good Manufacturing Practice (cGMP) regulations. Accepted certificates include:
  • cGMP certificate from an International Organization for Standardization (ISO) 17065-accredited certification body, demonstrating compliance with 21 Code of Federal Regulations (CFR) 210 and 21 CFR 211, or equivalent such as NSF/ANSI 455-4

FDA Approval Documentation

Manufacturers, importers, and repackers must provide documents confirming their products are legally marketed as OTC drugs in the United States. Products must either hold FDA approval for OTC sale or comply with an applicable FDA OTC monograph. Accepted documentation includes:
  • FDA OTC Monograph compliance statement (for products marketed under a monograph
  • FDA Drug Listing confirmation (NDC Directory record showing active listing)
  • FDA Facility Registration confirmation (DECRS record for the manufacturing establishment)
  • FDA-approved labeling and Drug Facts panel (for NDA/ANDA-approved products)
  • For products under FDA enforcement discretion, documents showing compliance with applicable regulations

Product Lab Test Report

Manufacturers, importers, and repackers must submit at least 1 valid product lab test report from an approved laboratory. For detailed requirements, accepted report criteria, and the testing process, see the TikTok Shop Partner Laboratories & Testing Guide.
Accepted Test Report Types
The test report must be 1 of the following:
  1. A valid test report from TikTok Shop Accredited Partner Laboratories (listed below); or
  2. A valid test report from an in-house ISO/IEC 17025–accredited laboratory, plus a valid ISO certificate; or
  3. A valid test report from an in-house laboratory, plus a valid cGMP certificate compliant with 21 CFR 210 or 21 CFR 211
TikTok Shop Accredited Partner Laboratories
Accepted partner laboratories include:
Test Report Requirements
All submitted test reports must meet all of the following:
  • Issued within the last 180 days
  • Cover products that match the purchase invoice, including brand and manufacturer details
  • Display the same company name and address as the selling account
    • If the seller is the manufacturer, the manufacturer listed on the report must match the selling account
Required Test Content
A valid test report must include:
  • Microbiological testing
  • Heavy metals testing
  • Contaminant testing, such as pesticides or residual solvents (as labeled on the report)
  • Content claims / potency / label claim verification
    • The reported amount of each active ingredient per dosage unit must fall within the permitted tolerance range
For ingestible OTC products, the test report must also confirm the product was tested to and meets:
  • 16 CFR Part 1700 (Poison Prevention Packaging Act)
  • 21 CFR 201 Subpart C (Labeling Requirements for Over-the-Counter Drugs)
  • 21 CFR 207 Subpart C (National Drug Code)

Resellers

If you are applying to sell OTC medications as a reseller, you must submit the following documents:

Purchase Invoice or Proof of Purchase

Resellers must submit a legible purchase invoice or proof of purchase issued by the product’s manufacturer or distributor. The invoice must meet all of the following requirements:
  • Be dated within the last 180 days
  • Show the same name and address as the selling account
  • Include the full name and address of the manufacturer or distributor
  • Contain products belonging to the applicable category
  • Reflect a combined purchase of at least 400 units
  • Be written in English or Chinese
Additional Information:
  • Pricing information may be omitted (optional)
  • TikTok Shop reserves the right to verify the submitted documentation by contacting the product vendor listed on the invoice
  • Retail order confirmations or invoices are not accepted

Reseller Authorization

Resellers must provide documents confirming they are authorized by the brand owner or manufacturer to sell the product. Accepted forms of authorization include:
  • A letter of authorization from the brand owner or manufacturer
  • A distribution agreement confirming authorized reseller status
NOTE: Unauthorized resellers and sellers sourcing products through retail arbitrage or gray-market channels are not eligible for category access.

Product Lab Test Report

Resellers must submit at least 1 valid product lab test report from an approved laboratory. For detailed requirements, accepted report criteria, and the testing process, see the TikTok Shop Partner Laboratories & Testing Guide.
Accepted Test Report TypesThe test report must be issued by a TikTok Shop Accredited Partner Laboratory, including:
Test Report RequirementsAll submitted test reports must meet all of the following:
  • Issued within the last 180 days
  • Cover products that match the purchase invoice, including brand and manufacturer details
  • Display the same company name and address as the selling account
    • If the seller is the manufacturer, the manufacturer listed on the report must match the selling account
Required Test ContentA valid test report must include:
  • Microbiological testing
  • Heavy metals testing
  • Contaminant testing, such as pesticides or residual solvents (as labeled on the report)
  • Content claims / potency / label claim verification
    • The reported amount of each active ingredient per dosage unit must fall within the permitted tolerance range

Product Listing Requirements

All OTC product listings must meet the following requirements prior to being published on TikTok Shop.
Listing attributesRequired imagesLabeling requirementsClaims
Detail page fields
  • Item name (official drug name)
  • Brand name
  • Manufacturer name
  • National Drug Code (NDC) number
  • Item form (for example, cream, ointment, gel, or spray)
  • Active ingredients
  • Specific uses for the product
  • Age range description
  • Product benefits
  • Number of items
  • Whether product is expirable and expiration type
  • Shelf life
  • Appropriate cautionary statement
Must be visible in photos
  • Complete Drug Facts panel (and continued panels, if applicable)
  • NDC number, where applicable
  • Product identity statement (official drug name and category)
  • Name and address of manufacturer, importer, distributor, or authorized representative
  • Brand name or registered trademark
  • Any compliance or tamper-evident markings
Images must show all sides of the product packaging and demonstrate that the product matches what is tested and listed on the detail page.
Must appear on product
  • Name of the drug
  • Drug Facts panel, including active ingredients and purpose, uses, warnings, directions for use, and inactive ingredients
  • Name and address of manufacturer, packer, or distributor
  • Net quantity of contents
  • Lot number or batch code
  • Expiration date
  • All products must comply with 21 CFR Part 201
  • All OTC product labels, Drug Facts panels, and packaging must be in English
  • Additional languages are permitted alongside English, but English must always be present and legible on the Drug Facts panel, warnings, and directions for use
  • Products must either hold FDA approval for OTC sales or comply with an applicable FDA OTC monograph
Prohibited in listings
  • The FDA logo
  • The claim "FDA approved" unless the product holds a formal NDA or ANDA approval. OTC monograph drugs may not use this claim
  • Claims that contradict or exceed approved labeling
  • Unverified claims, such as effects of prescription medicines or conditions not covered by the relevant monograph, NDA, or ANDA

Toddler OTC Medications (Ages 2-3)

Toddler OTC Medications are OTC drug products labeled, advertised, or otherwise marketed for use by toddlers. All of the general OTC requirements above also apply to Toddler OTC. Where a Toddler OTC requirement is stricter than a general requirement, follow the stricter Toddler OTC requirement.
Only the following Toddler OTC subcategories are open for listing:
  • Pain Relief & Fever Reducers – acetaminophen, ibuprofen (children's liquid, chewable, dissolvable)
  • Digestive Relief – children's antacids, gas relief (simethicone)
Toddler cough and cold medications and toddler allergy relief medications are not permitted.

Seller Qualification

Toddler OTC is invite only and restricted to vetted sellers.
  • Eligible sellers must be established healthcare brands or authorized distributors with a documented FDA compliance history
  • Sellers are subject to periodic revalidation. Continued eligibility may be revoked upon documentation gaps, enforcement actions, or product integrity failures

Product-Level Requirements

  • Product label images showing all sides of the packaging, including: Drug Facts, active ingredients, purpose, uses, warnings, directions, inactive ingredients, manufacturer/distributor, NDC, lot number, and expiration date
  • A Regulatory Pathway Declaration for each product, as described above
  • Supply-chain legitimacy proof:
    • Manufacturers: FDA Drug Establishment Registration and cGMP Certificate
    • Resellers: Proof of Purchase (invoice), Brand Authorization Letter, and Compliance Attestation
  • A valid Certificate of Analysis (COA) issued within the last 180 days, confirming the product was tested to and meets 16 CFR Part 1700, 21 CFR 201 Subpart C, and 21 CFR 207 Subpart C. Accepted laboratory types are the same as those listed under Product Lab Test Report above

Product Detail Page (PDP) Requirements

  • The product detail page must surface the full Drug Facts panel, dosage directions, age and weight-based dosing guidance, and all warnings before purchase
  • Product images submitted must be exact matches to current approved label artwork; hidden or extended packaging information must be fully captured

Prohibited in Toddler OTC

Products that are not permitted for toddlers ages 2-3, regardless of general OTC eligibility include, but are not limited to:
  • Products labeled "consult a doctor for children under 4 years"
  • Products without explicit manufacturer dosing for ages 2-3 on the label
  • Cold and cough medications
  • Combination cold medications
  • Allergy, sinus, and asthma medications
  • Decongestants
  • Antidiarrheal drug products (including loperamide and bismuth subsalicylate)
  • Topical anesthetic drug products (including lidocaine and benzocaine)
  • Products containing loperamide or bismuth subsalicylate

Claims and Data Use

  • Prohibited claims include, but are not limited to: "natural," "safe," "doctor recommended," and any pediatric efficacy or safety claim not substantiated by and aligned with the manufacturer-approved label
  • Purchase data and health-condition signals from this category may not be used for ad targeting or personalized recommendations
Required Listing AttributesIn addition to the attributes in Product Listing Requirements above, Toddler OTC listings must include:
MandatoryOptional
Brand nameManufacturerCountry / region of originActive ingredientsStrengthRegulatory pathway (NDA/ANDA application number, or NDC for monograph products)Dosage form (liquid, chewable tablet, dissolvable strip, drops, suppository, and similar)Medication functionDirections for useRecommended age rangeDosing guidance (age and weight-based)Net contentsSafety warningShelf life/expirationFlavorQuantity / count per packInactive ingredientsDye-free or alcohol-free claims

Enforcement Actions and Appeals

We regularly review shops for compliance with this document and our Restricted Products Policy. Violations include, but are not limited to:
  • Listing OTC products without an active invitation to the category
  • Submitting documentation that is inaccurate, fraudulent, or modified
  • Listing prohibited ingredients or product types
  • Failing to display the Drug Facts panel or other required labeling in product listings
  • Selling products in packaging that is not tamper-evident, sealed, or new [All OTC drug products must be in sealed, tamper-evident packaging. The packaging must include a tamper-evident feature that visibly shows if the package has been opened]
  • Using the FDA logo or claiming "FDA approved" inappropriately
If any violations are identified, TikTok Shop may take enforcement action at our sole discretion. This may include, but is not limited to:
  • Removing access to offer OTC products
  • Deducting points from your Account Health Rating
  • Removing product listings
  • Revoking your access to offer products for sale
  • Issuing refunds to customers
For more information on enforcement actions, refer to our Seller Enforcement Policy. To appeal an enforcement action, visit the Appeals section for guidance.
This policy is provided for informational purposes to help sellers understand TikTok Shop's requirements. It is not legal advice and does not create any additional legal obligation beyond applicable law. Sellers are solely responsible for complying with all applicable federal, state, and local laws and regulations, including any changes to those laws or regulations after publication of this policy, and should consult their own legal counsel with questions about their specific obligations.

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