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.
• All OTC medications must comply with 21 CFR Part 201 and be labeled in English. Additional languages may appear alongside English (for example, English and French), but English must always be present and legible on the Drug Facts panel, warnings, and directions for use. Listings where required label content appears only in a language other than English will fail listing review. Previously approved listings may also be removed if identified during a recall review, regardless of prior approval status.

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
  • Acetaminophen
  • Ibuprofen
• 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

For toddler-specific OTC medications (ages 2-3), see Toddler OTC Medications below.

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
• Hydrocortisone: Above 1% concentration
• Diclofenac: Above 1% concentration
• Ketoconazole: Above 1% concentration

Quantity-Restricted Ingredients

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

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

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)

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:

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.

General Certificate of Conformity (GCC)

Manufacturers, importers, and repackers must submit a General Certificate of Conformity (GCC) for each ingestible OTC product. The GCC must include:

• Product description: A clear and specific description of the product covered by the GCC.
• Applicable product safety rules, including:
  • 21 CFR Part 73, Subpart B – Drugs (approved color additives in OTC medications)
  • 16 CFR Part 1700 – Poison Prevention Packaging Act
  • 21 CFR Part 207, Subpart C – National Drug Code (NDC) requirements. All pharmaceutical OTC products must include a valid NDC on the product packaging and in the product documentation.
• Testing details: The date(s) and location(s) where the product was tested for each applicable safety rule.
• Certifying party: The name, full mailing address, and phone number of the U.S. manufacturer or importer certifying the product.
• Record keeper: The name, full mailing address, email address, and phone number of the person responsible for maintaining the test records.
• Manufacturing details:
  • Month and year of manufacture
  • Country of manufacture, and if applicable, the state and city or administrative region where the product was manufactured or assembled
  • If the manufacturer operates more than one facility in the same city, the full street address of the specific manufacturing location

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

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:

• Eurofins
• NSF (National Sanitation Foundation) International
• SGS (General Society of Surveillance)
• UL (Underwriters Laboratories) Solutions
• TÜV Sud
• Mérieux NutriSciences
• Intertek
• Certified Laboratories

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 attributes	Required images	Labeling requirements	Claims
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, 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)

TikTok Shop allows eligible sellers to list over-the-counter medications with explicit manufacturer dosing for toddlers ages 2-3. Access to this category is invite-only. Sellers must be nominated by an account manager, complete a pre-screening questionnaire, and submit the qualification documents listed below.
Sellers must be vetted healthcare brands or authorized distributors with documented FDA compliance history. Approval applies at both the seller level and the product level, so each product listing requires its own review. Sellers are also subject to periodic revalidation, and eligibility may be revoked due to documentation gaps, enforcement actions, or product integrity issues.

Permitted Products (Ages 2-3)

The following product types are permitted where the product label includes explicit manufacturer dosing for ages 2-3 and a complete Drug Facts panel.
Fever and Pain

• Acetaminophen
• Ibuprofen (only where the product label includes dosing for ages 2-3)

Digestive

• Stomach relief products (for example, simethicone-based products)

Prohibited Products (Ages 2-3)

The following products are not permitted for toddlers ages 2-3, regardless of general OTC eligibility:

• 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

Documentation Requirements (Ages 2-3)

In addition to the general documentation requirements in this document, sellers listing toddler OTC medications must submit:

• NDA/ANDA products: Submit the NDA or ANDA application number and a screenshot from the FDA NDC Directory confirming the product listing, approved application number, and marketing status.
• OTC Monograph products: Submit the National Drug Code (NDC) and a screenshot from the FDA NDC Directory confirming the product's OTC Monograph listing.
• Manufacturers: Submit the FDA Drug Establishment Registration and a valid cGMP certificate.
• Resellers: Submit a purchase invoice or proof of purchase dated within the last 180 days that:
  • matches the selling account name and address
  • includes the full name and address of the manufacturer or distributor
  • covers products in this category
  • reflects a combined purchase of at least 400 units
  • Documents must be in English or Chinese. Retail order confirmations are not accepted.
• Reseller authorization: Submit a brand authorization letter or distribution agreement confirming authorized reseller status, plus a compliance attestation.
• Certificate of Analysis (COA) or laboratory test report: Submit a valid COA or laboratory test report issued within the last 180 days. The report must match the product and selling account details and confirm testing for:
  • 21 CFR Part 201, Subpart C
  • 21 CFR Part 207, Subpart C
  • microbiological testing
  • heavy metals
  • contaminants (such as pesticides or residual solvents)
  • active ingredient potency or label claim verification

Listing Requirements (Ages 2-3)

Product listings for toddler OTC medications must include the following information, images, and labeling to accurately represent the product and support compliance with FDA requirements.

Required Product Information

The product detail page must include:

• Official drug name and brand name
• Manufacturer name
• Country or region of origin
• Regulatory pathway details:
  • NDA or ANDA application number for approved products
  • National Drug Code (NDC) for OTC Monograph products
• Active ingredients, strength, and product benefits or labeled uses
• Dosage form
• Directions for use, including age- and weight-based dosing guidance
• Net contents
• Lot or batch code
• Expiration date or shelf life
• Recommended age range (must explicitly reflect ages 2-3)
• Safety warnings and any other cautionary statements required on the approved label

Product Images

Product images must accurately represent the product and clearly display all required labeling information.

• Show all sides of the product packaging.
• Clearly display:
  • The complete Drug Facts panel, including any continued Drug Facts panels
  • The product identity statement
  • The NDC, where applicable
  • The manufacturer, importer, or distributor name and address
  • The brand name
  • Any tamper-evident or other required compliance markings
• Product images must exactly match the current approved label artwork.
• Hidden or extended packaging information must be fully captured.

Labeling and Claims

Product listings and labels must accurately reflect the approved product labeling.

• The product detail page must surface the complete Drug Facts panel, dosage directions, age- and weight-based dosing guidance, and all warnings before purchase.
• All labels, Drug Facts panels, and packaging must be in English. Additional languages are permitted only if English is also present and legible on the Drug Facts panel, warnings, and directions for use.
• Sellers may not use the FDA logo.
• Sellers may not claim "FDA approved" unless the product has formal NDA or ANDA approval.
• Sellers may not make claims that contradict, exceed, or are not supported by the approved label or applicable OTC monograph.

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.