This product has been identified as an unapproved drug product. Amazon policy prohibits the listing or sale of unapproved drugs

The notice is short and gives you almost nothing to work with:

This product has been identified as an unapproved drug product. Amazon policy prohibits the listing or sale of unapproved drugs.

Then Seller Support starts asking for drug documentation — frequently an NDC code, which your dietary supplement does not have and never will, because NDC codes identify drug products.

Sellers respond to this by explaining, at increasing length, that their product is a dietary supplement. That is understandable and it does not work, because Amazon is not confused about what you are selling. Something about the product has met its definition of a drug.

Three different situations, three different fixes

Work out which one you are in before you do anything else.

1. Your claims moved the product into drug territory

The most common cause by a wide margin. In regulatory terms, a product that claims to treat, prevent, cure or mitigate a disease is a drug — and if it has not been through drug approval, it is an unapproved one. That is not Amazon being pedantic; it is how the classification works.

This is the recoverable version. Remove the claims everywhere they appear — listing copy, A+ content, backend fields, image overlays — and appeal.

The critical qualifier: if the claim is printed on your physical packaging, this stops being a listing fix. See prohibited disease claims on a supplement or consumable, because that route often has no path back for the ASIN at all.

2. Your product genuinely is an OTC drug under a monograph

A real and frustrating variant. Products legitimately covered by an FDA OTC monograph get flagged as unapproved drugs, which is a different thing entirely — monograph coverage is precisely what makes them approved for sale.

This is a categorisation problem, not a claims problem. You need the ASIN correctly classified, which means reaching someone who can reclassify it rather than appealing on compliance grounds. Sellers report this being the slowest of the three, because the standard appeal path has no route for “your classification is wrong.”

3. Plain misclassification

Electrolyte tablets, vitamin blends and ordinary supplements sometimes land here with no disease claims anywhere. Detection is automated and it makes mistakes.

The tell is the NDC request: support asks for drug paperwork and keeps asking regardless of what you send, because the case is being handled against a drug checklist.

What to do

1. Audit your claims first, even when you are certain there are none. Include the physical label and every product image. This is the cause in most cases, and ruling it out is fast.
2. Check your ingredients against pharmaceutical associations. An ingredient with a known drug use can trigger the classification on its own.
3. Identify which of the three situations applies and say so explicitly in your first response. A case that opens with “this ASIN has been classified as a drug; it is a dietary supplement and the classification needs correcting” goes somewhere different from one that argues about claims.
4. Do not supply drug documentation you do not have. Requests for an NDC code are a symptom of the misclassification. Attempting to satisfy them confirms the wrong frame.
5. Escalate on categorisation if claims are genuinely clean. This is one of the cases where a forum moderator with a case ID has produced movement that support cases did not.

Do not let it sit

These notices usually carry account-level language — that leaving violations unaddressed may result in account deactivation. That is not boilerplate you can safely ignore while you work out your response. Even a holding reply that states which situation you believe applies is better than silence.

The wider pattern

Amazon’s classification runs on what your listing and label say, not on what your product legally is. A supplement that claims a disease benefit is a drug by definition, and no amount of insisting on the word “supplement” changes the sentence that triggered it.

Keep reading: How to fix a listing suppressed for an ingredient claim · Reinstating after a cGMP deactivation · The Dietary Supplement Listing Act, explained