Home NDC 68071-3877 Diphenhydramine HCl
Product NDC 68071-3877
11-digit product format 680713877
Labeler code 68071
Product ID 68071-3877_47acca00-4497-1432-e063-6294a90a7bc8
Type HUMAN OTC DRUG
Nonproprietary name Diphenhydramine HCl
Dosage form CAPSULE
Route ORAL
Labeler NuCare Pharmaceuticals,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 2027-12-31
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 2027-12-31 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 · 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 68071-3877-3 Diphenhydramine HCl 30 in 1 BOTTLE CAPSULE 30 3 68071-3877-5 Diphenhydramine HCl 15 in 1 BOTTLE CAPSULE 15 3 68071-3877-6 Diphenhydramine HCl 60 in 1 BOTTLE CAPSULE 60 3
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 Sample Exclude flag Status 68071-3877-3 68071387703 30 CAPSULE in 1 BOTTLE (68071-3877-3) 30 capsule 2025-08-12 No No Current 68071-3877-5 68071387705 15 CAPSULE in 1 BOTTLE (68071-3877-5) 15 capsule 2026-01-05 No No Current 68071-3877-6 68071387706 60 CAPSULE in 1 BOTTLE (68071-3877-6) 60 capsule 2025-08-14 No No Current