SLEEP AID

Product NDC
76162-911
11-digit product format
761620911
Labeler code
76162
Product ID
76162-911_4279e0bd-a592-d469-e063-6294a90aff1b
Type
HUMAN OTC DRUG
Nonproprietary name
DIPHENHYDRAMINE HYDROCHLORIDE
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
Company name: Topco Associates, LLC
Application
M010
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-09-26
Substance
DIPHENHYDRAMINE HYDROCHLORIDE
Active strength
25 mg/1
Pharmacologic classes
Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
TC2D6JAD40DIPHENHYDRAMINE HYDROCHLORIDE147-24-0DIPHENHYDRAMINE HYDROCHLORIDE

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
76162-911-12761620911121 BLISTER PACK in 1 CARTON (76162-911-12) / 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK1 blister pack2024-09-26NoNoHistorical
76162-911-24761620911242 BLISTER PACK in 1 CARTON (76162-911-24) / 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK2 blister pack2024-09-26NoNoHistorical
76162-911-48761620911484 BLISTER PACK in 1 CARTON (76162-911-48) / 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK4 blister pack2024-09-26NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
NIGHTTIME SLEEP-AIDCompany name: Topco Associates, LLC2025-10-31HUMAN OTC DRUG LABEL4
NIGHTTIME SLEEP-AIDCompany name: Topco Associates, LLC2024-12-26HUMAN OTC DRUG LABEL3