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 make sure they follow applicable federal, state, and local laws and regulations, including 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. 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.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're 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 will 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)
• 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 (e.g., bongs, pipes, vaporizers, pill presses, 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 (e.g., 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 ISO 17065-accredited certification body, demonstrating compliance with 21 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 one 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 one 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:

• 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

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 one 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.

Enforcement Actions and Appeals

We regularly review your shop’s adherence to 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:

• 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. If you would like to appeal an enforcement action, visit the Appeals section for guidance.