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:
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:
|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)
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:
In Seller Central, select the Performance tab and choose
Under Manage your compliance in the bottom right corner, click
Product Compliance Requests.
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.
Provide compliance documents and information in the Provide
Documents section, or provide appeal information and documents in the
Appeal Request section.
Click Submit for Approval to send your submission for review by
Note: Test reports must contain images of the tested
products that are sufficient to demonstrate that the product tested is the same as the
product listed on the detail page.
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.
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.