Home NDC 83720-502 Diphenhydramine Hydrochloride
Product NDC 83720-502
11-digit product format 837200502
Labeler code 83720
Product ID 83720-502_31583c7e-3649-d899-e063-6394a90aa63f
Type HUMAN OTC DRUG
Nonproprietary name Diphenhydramine Hydrochloride
Dosage form SOLUTION
Route ORAL
Labeler Oncor Pharmaceuticals
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2025-03-27
Substance DIPHENHYDRAMINE HYDROCHLORIDE
Active strength 12.5 mg/5mL
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 Hydrochloride
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DIPHENHYDRAMINE HYDROCHLORIDE 12.5 mg/5mL
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 83720-502-04 Diphenhydramine Hydrochloride 118 mL in 1 BOTTLE SOLUTION 118 2 83720-502-16 Diphenhydramine Hydrochloride 473 mL in 1 BOTTLE SOLUTION 473 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 83720-502 DIPHENHYDRAMINE HYDROCHLORIDE SOLUTION [ONCOR PHARMACEUTICALS] 2 Current NDC, 2 package rows 20250330_06ecba97-c790-4672-a8c3-f9caf6272d26.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 · 3,550 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 83720-502-04 83720050204 118 mL in 1 BOTTLE (83720-502-04) 118 ml 2025-03-27 No No Current 83720-502-16 83720050216 473 mL in 1 BOTTLE (83720-502-16) 473 ml 2025-03-27 No No Current