Home NDC 72789-317 Diphenhydramine Hydrochloride
Product NDC 72789-317
11-digit product format 727890317
Labeler code 72789
Product ID 72789-317_56d551ca-b3ee-5d72-e063-6294a90af6c8
Type HUMAN OTC DRUG
Nonproprietary name Diphenhydramine Hydrochloride
Dosage form CAPSULE
Route ORAL
Labeler PD-Rx Pharmaceuticals, Inc.
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2022-04-14
Marketing end 2028-04-30
Substance DIPHENHYDRAMINE HYDROCHLORIDE
Active strength 25 mg/1
Pharmacologic classes Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
NDC exclude flag No
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 Hydrochloride Active Ingredients# Ingredient, Strength table Ingredient Strength DIPHENHYDRAMINE HYDROCHLORIDE 25 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 1049909 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 72789-317-10 Diphenhydramine Hydrochloride 10 in 1 BOTTLE, PLASTIC CAPSULE 10 6 72789-317-12 Diphenhydramine Hydrochloride 12 in 1 BOTTLE, PLASTIC CAPSULE 12 6 72789-317-15 Diphenhydramine Hydrochloride 15 in 1 BOTTLE, PLASTIC CAPSULE 15 6 72789-317-20 Diphenhydramine Hydrochloride 20 in 1 BOTTLE, PLASTIC CAPSULE 20 6 72789-317-30 Diphenhydramine Hydrochloride 30 in 1 BOTTLE, PLASTIC CAPSULE 30 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 72789-317 DIPHENHYDRAMINE HYDROCHLORIDE CAPSULE [PD-RX PHARMACEUTICALS, INC.] 5 Current NDC, 5 package rows 20250221_879a7804-f3d4-4a3d-bc92-b473499d6c95.zip
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 73 of 178 · 3,551 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 72789-317-10 72789031710 10 CAPSULE in 1 BOTTLE, PLASTIC (72789-317-10) 10 capsule 2023-04-05 2028-02-29 No No Historical 72789-317-12 72789031712 12 CAPSULE in 1 BOTTLE, PLASTIC (72789-317-12) 12 capsule 2023-04-05 2028-02-29 No No Historical 72789-317-15 72789031715 15 CAPSULE in 1 BOTTLE, PLASTIC (72789-317-15) 15 capsule 2023-04-05 2028-02-29 No No Historical 72789-317-20 72789031720 20 CAPSULE in 1 BOTTLE, PLASTIC (72789-317-20) 20 capsule 2023-04-05 2028-02-29 No No Historical 72789-317-30 72789031730 30 CAPSULE in 1 BOTTLE, PLASTIC (72789-317-30) 30 capsule 2023-04-05 2028-02-29 No No Historical