Diphenhydramine HCL

Product NDC
72789-532
11-digit product format
727890532
Labeler code
72789
Product ID
72789-532_43800734-7ff6-fb15-e063-6394a90aa530
Type
HUMAN OTC DRUG
Nonproprietary name
Diphenhydramine HCL
Dosage form
CAPSULE
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2010-01-27
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 formatDescriptionUnitsMarketing startSampleExclude flagStatus
72789-532-207278905322020 CAPSULE in 1 BOTTLE, PLASTIC (72789-532-20) 20 capsule2025-11-13NoNoHistorical
72789-532-307278905323030 CAPSULE in 1 BOTTLE, PLASTIC (72789-532-30) 30 capsule2025-10-16NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Drug FactsPD-Rx Pharmaceuticals, Inc.2025-11-13HUMAN OTC DRUG LABEL5