Policy AdvisorPolicyTikTok Source

Over-the-Counter (OTC) Medications Requirements

Captured: TikTok page date: Hash: 163aebe25cec

Creator TL;DR

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

TikTok Shop allows only eligible sellers to list certain OTC medications, and sellers must also follow applicable laws, FDA labeling rules, DEA rules, and the Restricted Products Policy. The policy lists permitted OTC categories, prohibited ingredients/products, and documentation needed for sellers, manufacturers, importers, repackers, and resellers.

Key points

  • Only eligible sellers can list or sell OTC medications.
  • Check both this OTC policy and the Restricted Products Policy before listing.
  • Follow federal, state, and local laws, plus FDA labeling and DEA rules.
  • Permitted OTC items are limited to the categories listed in the source.
  • Some ingredients and product types are prohibited, including controlled substances, CBD, homeopathic products, injectable drug products, and drug paraphernalia.
  • DXM products may be subject to state-level sales or shipping restrictions.
  • Eligible sellers may need cGMP documents and product lab test reports.
  • Resellers need a qualifying purchase invoice, reseller authorization, and a lab test report.
  • TikTok may remove listings, restrict access, issue refunds, or take other enforcement action for violations.

Say / show

  • Only eligible sellers may list OTC medications.
  • Verify the product fits a permitted OTC category before listing.
  • Make sure listings accurately disclose all active ingredients, including DXM where applicable.
  • Use authentic, unmodified documents in original format.
  • Use accepted lab testing sources and meet the listed test-report requirements.
  • Confirm reseller invoices are dated within the last 180 days and meet all stated fields.
  • Verify against the TikTok source before acting.

Do not say / show

  • Do not claim any seller can list OTC medications without eligibility review.
  • Do not list prohibited ingredients or products such as CBD, controlled substances, or injectable drug products.
  • Do not use retail arbitrage or gray-market sourcing for reseller access.
  • Do not submit retail order confirmations or invoices as reseller proof of purchase.
  • Do not imply TikTok allows OTC products beyond the listed permitted categories.
  • Do not state requirements not supported by the source.

Violation risks

  • Listing without eligibility.
  • Listing prohibited ingredients or product types.
  • Missing or invalid documentation.
  • Incorrect or incomplete product ingredient disclosure.
  • Noncompliant reseller sourcing or authorization.
  • Policy enforcement actions including listing removal, loss of access, refunds, and Account Health Rating deductions.

Who it affects

  • Sellers
  • Resellers
  • Manufacturers
  • Importers
  • Repackers

Source notes

  • This summary is based only on the provided TikTok source text.
  • Some sections referenced in the source say to open sections or consult other guides for details; those details are not included here.
  • Verify all requirements directly against the TikTok source before listing or selling.

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.
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:
  • 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
  • Scars & Stretch Marks
    • Stretch mark removal creams, gels, lotions, and oils
    • Scar tapes or patches

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

  • Pseudoephedrine (DEA List I Chemical)
  • Ephedrine (DEA List I Chemical)
  • Phenylpropanolamine
  • Ergotamine
  • 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
  • Kratom
  • Salvia divinorum
  • Jimson weed
  • Peyote and mescaline
  • 1,4-Butanediol
  • Amanita muscaria and Panther amanitas
  • Poppy pods, poppy straw, poppy straw concentrate, and poppy tea
  • GLP-1 (glucagon-like peptide-1) agonists

Concentration-Restricted Ingredients

  • Iodine above 2.2% concentration (including Lugol’s Solution)
  • Lidocaine above 4% concentration

Quantity-Restricted Ingredients

  • Loperamide – limited to ≤48 mg per package; capsule and tablet formats must be packaged in blister packs only

Other Prohibited Products

  • Homeopathic products of any form (oral, topical, or ophthalmic)
  • Products containing cannabidiol (CBD)
  • 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)

State-Based Restrictions for DXM Products

Some OTC medications may contain dextromethorphan (DXM), an active ingredient commonly used in cough suppressant products. DXM products may be subject to state-level sales or shipping restrictions.If a product contains DXM, customers in states where DXM cannot be sold or shipped will be unable to purchase the product. Sellers must make sure product listings accurately disclose all active ingredients, including DXM, where applicable.

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 may be required to submit the following:

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

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 TypesThe 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 LaboratoriesAccepted partner laboratories include:
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

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 (where applicable)
  • 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 (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 and be labeled in English. Products must either hold FDA approval for OTC sale 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

Enforcement Actions and Appeals

We regularly review shops for compliance with this document and our Restricted Products Policy. 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.

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