Home NDC 0904-7559 Diphenhydramine HCl
Product NDC 0904-7559
11-digit product format 009047559
Labeler code 0904
Product ID 0904-7559_45b07e82-0ce9-492f-8303-65c992c7dc32
Type HUMAN OTC DRUG
Nonproprietary name diphenhydramine hydrochloride
Dosage form SOLUTION
Route ORAL
Labeler Major Pharmaceuticals
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2025-07-15
Substance DIPHENHYDRAMINE HYDROCHLORIDE
Active strength 25 mg/10mL
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 25 mg/10mL
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 1049906 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 0904-7559-66 Diphenhydramine HCl 10 mL in 1 CUP, UNIT-DOSE SOLUTION 10 2 0904-7559-72 Diphenhydramine HCl 10 in 1 CASE SOLUTION 10 2 0904-7559-72 Diphenhydramine HCl 10 in 1 TRAY SOLUTION 10 2
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 0904-7559-66 00904755966 10 mL in 1 CUP, UNIT-DOSE 10 ml Historical 0904-7559-72 00904755972 10 TRAY in 1 CASE (0904-7559-72) / 10 CUP, UNIT-DOSE in 1 TRAY / 10 mL in 1 CUP, UNIT-DOSE (0904-7559-66) 10 tray 2025-08-01 No No Current