Home NDC 72789-532 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 Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Diphenhydramine HCL
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DIPHENHYDRAMINE HYDROCHLORIDE 50 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination TC2D6JAD40 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1020477 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 72789-532-20 Diphenhydramine HCL 20 in 1 BOTTLE, PLASTIC CAPSULE 20 5 72789-532-30 Diphenhydramine HCL 30 in 1 BOTTLE, PLASTIC CAPSULE 30 5
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 74 of 180 · 3,583 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 72789-532-20 72789053220 20 CAPSULE in 1 BOTTLE, PLASTIC (72789-532-20) 20 capsule 2025-11-13 No No Current 72789-532-30 72789053230 30 CAPSULE in 1 BOTTLE, PLASTIC (72789-532-30) 30 capsule 2025-10-16 No No Current