I noticed several posts in the forums with a similar issue and no resolution, but I do believe I have figured out why. Unfortunately, I haven't been able to get this explanation to somebody in Amazon with the ability to fix it.

Amazon keeps requesting an NDC code, which I and other sellers have provided, but Amazon has started rejecting those NDC codes as "invalid".

I was told at one point in my back-and-forth with the restricted products team (active case 16488912501) that "Provided NDC Code is invalid, and the marketing category field result is not matching our database."

I believe Amazon's database has not been updated to recognize that the Marketing Category field for OTC Monograph Drugs has changed.

Starting in September 2023, the FDA changed how OTC monograph drugs are listed in the NDC Directory. I can't post a link, but the FDA page for "Electronic Drug Registration and Listing System (eDRLS)" indicates that, as of 9/14/2023:

• For Marketing Category: "OTC monograph final" and "OTC monograph not final" have been replaced with "OTC Monograph Drug"
• For Application Number, the "part###" reference has been replaced with a new monograph reference "M###"
• These changes were available starting 9/14/2023, but are now mandatory as of 10/1/2024

Amazon's database is still looking for the Marketing Category to match either "OTC monograph final" or "OTC monograph not final", but it is rejecting "OTC Monograph Drug".

I had one of our products (ASIN B08C78PBJB) flagged as restricted on 9/26 (case 16169055521). I was able to provide the requested information (packaging images, Drug Facts label, and NDC code), and it was reinstated the same day. It was still listed in the NDC Directory using "OTC monograph final".

On 10/1/2024, I updated my product information in the NDC Directory to reflect the new requirements.

Now, after providing the same set of information for four other ASINs that are the exact same type of product that was reinstated, they are having their NDC code rejected as invalid, due to Amazon not recognizing "OTC Monograph Drug".

Can an Amazon employee help get this information to somebody that can make this correction? This isn't asking Amazon to change any policy - Amazon isn't implementing it's own policy correctly as a result of FDA changes.