Home NDC 69452-452 Allergy Relief
Product NDC 69452-452
11-digit product format 694520452
Labeler code 69452
Product ID 69452-452_4bd1057c-3ae7-5275-e063-6394a90af757
Type HUMAN OTC DRUG
Nonproprietary name Diphenhydramine HCl
Dosage form CAPSULE, LIQUID FILLED
Route ORAL
Labeler BIONPHARMA INC.
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-10-01
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 1020477 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 69452-452-20 Allergy Relief 1 in 1 CARTON CAPSULE, LIQUID FILLED 1 3 69452-452-20 Allergy Relief 100 in 1 BOTTLE CAPSULE, LIQUID FILLED 100 3 69452-452-83 Allergy Relief 300 in 1 BOTTLE CAPSULE, LIQUID FILLED 300 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 69452-452 ALLERGY RELIEF (DIPHENHYDRAMINE HCL) CAPSULE, LIQUID FILLED [BIONPHARMA INC.] 1 Current NDC, 3 package rows 20241003_1f737b76-14b5-618a-e063-6294a90a19c2.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 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 69452-452-20 69452045220 1 BOTTLE in 1 CARTON (69452-452-20) / 100 CAPSULE, LIQUID FILLED in 1 BOTTLE 1 bottle 2024-10-01 No No Current 69452-452-83 69452045283 300 CAPSULE, LIQUID FILLED in 1 BOTTLE (69452-452-83) 2026-03-02 No No Current