Ingestible over-the-counter (OTC) pain relievers

If you list products on our store, you must comply with all federal, state, and local laws and our policies applicable to those products and product listings, including this policy.

Ingestible over-the-counter (OTC) pain relievers covered by this policy

Ingestible OTC pain relievers are medications that are taken to reduce or relieve headaches, sore muscles, arthritis, or other aches and pains. A doctor’s prescription is not required to purchase OTC medications.

Two main types of ingestible OTC pain relievers are available to consumers:

• Acetaminophen; and
• Nonsteroidal anti-inflammatory drugs (NSAIDs)
  • Aspirin, naproxen sodium, and ibuprofen are all examples of NSAIDs.

Common dosage forms include tablets, gel capsules, powder, or liquid. These products vary in dosage concentration depending on strength and intended use.

Our policy for ingestible over-the-counter (OTC) pain relievers

Amazon requires that all ingestible OTC pain relievers have been tested to and comply with the specific regulations or standard requirements listed below:

Product	Regulation/Standard requirements
Ingestible over-the-counter (OTC) pain relievers	16 CFR Part 1700 (Poison Prevention Packaging Act); and 21 CFR 201 Subpart C (Labeling Requirements for Over-the-Counter Drugs); and 21 CFR 207 Subpart C (National Drug Code)

Required information

We may request this information from you at any time, so we recommend that you have it easily accessible:

• Your company name (if applicable) and seller ID
• Your contact information: email address and phone number
• A list of all ingestible OTC pain relievers that you list
• Product packaging and label images for all ingestible OTC pain relievers that you list
  • Product images must show all sides of the product packaging
  • Product images and detail page content must comply with FDA Labeling (21 CFR 201 Subpart C), as well as Amazon’s policy for OTC drugs. For more information on this specific policy and our requirements, visit Amazon’s policy on drugs and drug paraphernalia
• A General Certificate of Conformity (GCC) for all ingestible OTC pain relievers that you are applying to list
• Test reports from an ISO 17025 accredited lab that confirm that each product was tested to and meets the regulations of 16 CFR Part 1700 (Poison Prevention Packaging Act)

Some labs provide special Amazon rates for testing. To find more information about these providers, visit the Service Provider Network.

How to submit information

If you receive a request from us for compliance documents, complete the following steps to submit the requested information:

1. In Seller Central, select the Performance tab and choose Account Health.
2. Under Manage your compliance in the bottom right corner, click Product Compliance Requests.
3. To add compliance or appeal for a single product, click Add/Appeal Compliance. To add compliance or appeal for multiple products, select each product on the left hand side of the product and click Action Selected Products at the top of the product requirement table to make a selection about how you would like to submit documents and information.
4. Provide compliance documents and information in the Provide Documents section, or provide appeal information and documents in the Appeal Request section.
5. Click Submit for Approval to send your submission for review by Amazon.

Policy violations

If you do not provide the required information by the applicable deadline, we may:

• Remove the relevant product listings
• Suspend your ability to add new products, your listing privileges, or both
• Withhold any payments due to you
• Pursue legal action

We reserve the right to take any further actions that may be necessary in our sole discretion.

Additional resources

• Amazon services business solutions agreement
• Remove inventory overview
• Fix stranded inventory
• CPSC's Poison Prevention Packaging Act Business Guidance
• FDA’s OTC Drug Facts Label
• FDA’s National Drug Code Background Information

Disclaimer: The information provided on this page does not, and is not intended to, constitute legal advice. All information, content, and materials available on this site are for general informational purposes only.