FDA Registration for Antidiarrheal Drug Products
Antidiarrheal products containing kaolin or bismuth subsalicylate are regulated as OTC Monograph drugs by FDA — requiring drug establishment registration and product listing.
FDA Requirements for Antidiarrheal Drug Products
Antidiarrheal drug products are regulated as OTC drugs. FDA-approved active ingredients include kaolin and bismuth subsalicylate.
- FDA Drug Establishment Registration
- NDC Labeler Code
- Drug Listing with Drug Facts labeling
- Annual renewal October 1–December 31
The U.S. Food and Drug Administration (FDA) has an over-the-counter (OTC) monograph that establishes safety and effectiveness standards for certain antidiarrheal ingredients. This monograph applies to products containing bismuth subsalicylate or kaolin, which help relieve diarrhea symptoms like frequent loose stools. The FDA considers these ingredients safe and effective for OTC use when used according to the monograph’s dosing instructions.
| Active Ingredients | OTC Monograph Number |
|---|---|
| Bismuth subsalicylate | M008.10 (Part 335) |
| Kaolin | M008.10 (Part 335) |
These are not complete lists of ingredients in the FDA OTC drug monograph. The status of ingredients in the OTC monograph may change. Please contact the FDA for updated information.
Antidiarrheal Drug Products — FAQs
Are antidiarrheal products regulated as drugs by FDA?
What active ingredients are allowed in OTC antidiarrheal products?
Ready to Register Your Antidiarrheal Drug Products?
LMG handles drug establishment registration, OTC drug listing, and NDC labeler code for antidiarrheal drug products manufacturers worldwide.
Start Registration Contact Us