FDA Registration for OTC Sleep-Aid Drug Products
OTC sleep-aid products containing diphenhydramine HCl or diphenhydramine citrate are regulated as OTC Monograph drugs by FDA — requiring drug establishment registration and listing.
FDA Requirements for OTC Sleep-Aid Drug Products
OTC sleep-aid drug products are regulated under FDA’s OTC Nighttime Sleep-Aid Monograph. Permitted active ingredients include diphenhydramine HCl and diphenhydramine citrate.
- FDA Drug Establishment Registration
- NDC Labeler Code
- Drug Listing with Drug Facts labeling
- Annual renewal October 1–December 31
The FDA has an OTC monograph, M010, that outlines the regulations for over-the-counter nighttime sleep-aids. This ensures these medications are safe and effective for occasional sleep problems. These sleep-aids are typically meant for adults who have difficulty falling asleep, not staying asleep. The only approved active ingredients are diphenhydramine hydrochloride and citrate, which cause drowsiness. These medications come with labeling requirements to inform consumers about proper use and potential side effects.
| Active Ingredients | OTC Monograph Number |
|---|---|
| Diphenhydramine hydrochloride | M010.10 (Part 338) |
| Diphenhydramine citrate | M010.10 (Part 338) |
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.
OTC Sleep-Aid Drug Products — FAQs
Are OTC sleep-aids regulated as drugs?
What active ingredients are allowed in OTC sleep-aids?
Ready to Register Your OTC Sleep-Aid Drug Products?
LMG handles drug establishment registration, OTC drug listing, and NDC labeler code for otc sleep-aid drug products manufacturers worldwide.
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