GroundRules
21 CFR 338.10: Nighttime sleep-aid active ingredients.
Where this section sits in the code
- Title 21—Food and Drugs
- CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES
- SUBCHAPTER D—DRUGS FOR HUMAN USE
- PART 338—NIGHTTIME SLEEP-AID DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
- Subpart B—Active Ingredients
The active ingredient of the product consists of any of the following when used within the dosage limits established for each ingredient in § 338.50(d):
(a) Diphenhydramine hydrochloride.
(b) Diphenhydramine citrate.
Collected 2026-08-27T02:24:47Z. Source file · JSON