Why is my OTC product showing up on the Daily Med?

Answer:

The FDA has started the process of uploading OTC Final and OTC Not Final products onto the Daily Med. The FDA has uploaded backlogged submissions and will now upload any future submissions onto the Daily Med.

Please note that drugs marked "OTC monograph final" or "OTC monograph not final" are not checked for conformance to the monograph. Drugs marked "unapproved" on this Web site have not been reviewed by FDA for safety and efficacy and their labeling has not been approved.