21 C.F.R. § 338.3 Definition.
Title 21 - Food and Drugs
As used in this part: Nighttime sleep-aid. A drug that is useful for the relief of occasional sleeplessness by individuals who have difficulty falling asleep.
Title 21: Food and Drugs
PART 338—NIGHTTIME SLEEP-AID DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
Subpart A—General Provisions
§ 338.3 Definition.