Home NDC 82568-0004 Diphenhydramine HCl
Product NDC 82568-0004
11-digit product format 825680004
Labeler code 82568
Product ID 82568-0004_365baf41-5399-4fd7-e063-6294a90a81e1
Type HUMAN OTC DRUG
Nonproprietary name Diphenhydramine HCl
Dosage form CAPSULE
Route ORAL
Labeler AARNA USA INC.
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-12-06
Substance DIPHENHYDRAMINE HYDROCHLORIDE
Active strength 25 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 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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1020477 Internal RxNorm lookup 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 82568-0004-1 Diphenhydramine HCl 100 in 1 BOTTLE CAPSULE 100 4 82568-0004-2 Diphenhydramine HCl 1000 in 1 BOTTLE CAPSULE 1000 4
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 177 · 3,534 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 82568-0004-1 82568000401 100 CAPSULE in 1 BOTTLE (82568-0004-1) 100 capsule 2025-05-30 No No Current 82568-0004-2 82568000402 1000 CAPSULE in 1 BOTTLE (82568-0004-2) 1000 capsule 2025-05-30 No No Current