TopCare health NIGHTTIME MAXIMUM STRENGTH Sleep Aid

Product NDC
76162-438
11-digit product format
761620438
Labeler code
76162
Product ID
76162-438_267da9a1-6c85-4316-9aad-3fe5762c347a
Type
HUMAN OTC DRUG
Nonproprietary name
Diphenhydramine hydrochloride
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
Topco Associates LLC
Application
M010
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-08-01
Substance
DIPHENHYDRAMINE HYDROCHLORIDE
Active strength
50 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 formatDescriptionMarketing startSampleExclude flagStatus
76162-438-967616204389696 CAPSULE, LIQUID FILLED in 1 BOTTLE (76162-438-96) 2025-08-01NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
TopCare® health NIGHTTIME MAXIMUM STRENGTH Sleep AidTopco Associates LLC2025-08-01HUMAN OTC DRUG LABEL2