FDA Registration for Antiflatulent Drug Products
Antiflatulent products containing simethicone are regulated as OTC Monograph drugs by FDA — requiring drug establishment registration, NDC labeler code, and Drug Facts labeling.
FDA Requirements for Antiflatulent Drug Products
Antiflatulent (anti-gas) drug products are regulated by FDA. Simethicone (maximum daily dose 500mg) is the only active ingredient recognized in the OTC Antiflatulent Monograph.
- 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 regulates simethicone-based antiflatulent products. Simethicone is the only active ingredient allowed by the monograph, and it works by breaking up gas bubbles in the digestive system to relieve bloating, discomfort, and pressure.
| Active Ingredients | OTC Monograph Number |
|---|---|
| Simethicone; maximum daily dose 500 mg | M002.10 (Part 332) |
These are not complete list of ingredients in FDA OTC drug monograph. The status of ingredient in OTC monograph may change please contact FDA for updated information.
Antiflatulent Drug Products — FAQs
Are gas relief products regulated as drugs?
What is the permitted simethicone dosage in OTC antiflatulents?
Ready to Register Your Antiflatulent Drug Products?
LMG handles drug establishment registration, OTC drug listing, and NDC labeler code for antiflatulent drug products manufacturers worldwide.
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