FDA Registration for Antiemetic Drug Products
OTC antiemetic products for motion sickness and nausea (dimenhydrinate, meclizine HCl, cyclizine HCl) are regulated as OTC Monograph drugs by FDA.
FDA Requirements for Antiemetic Drug Products
OTC antiemetic drug products are regulated by FDA. Active ingredients permitted include dimenhydrinate, meclizine HCl, and cyclizine HCl for prevention and treatment of motion sickness.
- 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 a specific monograph, M009, outlining regulations for over-the-counter (OTC) antiemetic drugs used to treat nausea and vomiting. This monograph establishes which ingredients are safe and effective for OTC use, including cyclizine hydrochloride, dimenhydrinate, diphenhydramine hydrochloride, and meclizine hydrochloride. It also sets dosing limits for each ingredient to ensure safety. Essentially, OTC antiemetic products must adhere to this monograph to be legally sold over the counter.
| Active Ingredients | OTC Monograph Number |
|---|---|
| Cyclizine hydrochloride | M009.10 (Part 336) |
| Dimenhydrinate | M009.10 (Part 336) |
| Diphenhydramine hydrochloride | M009.10 (Part 336) |
| Meclizine hydrochloride | M009.10 (Part 336) |
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.
Antiemetic Drug Products — FAQs
Are motion sickness products OTC drugs?
What is the FDA OTC Monograph for antiemetics?
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