Home NDC 69452-445 Allergy Relief
Product NDC 69452-445
11-digit product format 694520445
Labeler code 69452
Product ID 69452-445_54dcfbdc-23e6-c4e3-e063-6294a90ad945
Type HUMAN OTC DRUG
Nonproprietary name Diphenhydramine HCl
Dosage form TABLET
Route ORAL
Labeler BIONPHARMA INC.
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2025-08-11
Substance DIPHENHYDRAMINE HYDROCHLORIDE
Active strength 50 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 Allergy Relief
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DIPHENHYDRAMINE HYDROCHLORIDE 50 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 1085945 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 69452-445-24 Allergy Relief 1 in 1 CARTON TABLET 1 3 69452-445-24 Allergy Relief 150 in 1 BOTTLE TABLET 150 3 69452-445-77 Allergy Relief 12 in 1 BLISTER PACK TABLET 12 3 69452-445-77 Allergy Relief 4 in 1 CARTON TABLET 4 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 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 69452-445-24 69452044524 1 BOTTLE in 1 CARTON (69452-445-24) / 150 TABLET in 1 BOTTLE 1 bottle 2025-08-11 No No Current 69452-445-77 69452044577 4 BLISTER PACK in 1 CARTON (69452-445-77) / 12 TABLET in 1 BLISTER PACK 4 blister pack 2025-08-11 No No Current