Home NDC 41163-585 allergy relief
Product NDC 41163-585
11-digit product format 411630585
Labeler code 41163
Product ID 41163-585_63f7d288-decf-44cd-8e08-9af3ced4eaa3
Type HUMAN OTC DRUG
Nonproprietary name Diphenhydramine HCl
Dosage form TABLET, CHEWABLE
Route ORAL
Labeler United Natural Foods, Inc. dba UNFI
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2009-03-20
Marketing end 2027-04-30
Substance DIPHENHYDRAMINE HYDROCHLORIDE
Active strength 12.5 mg/1
Pharmacologic classes Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
NDC exclude flag No
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
Brand name suffix Childrens Active Ingredients# Ingredient, Strength table Ingredient Strength DIPHENHYDRAMINE HYDROCHLORIDE 12.5 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 1049900 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 41163-585-44 allergy reliefChildrens 6 in 1 BLISTER PACK TABLET, CHEWABLE 6 16 41163-585-44 allergy reliefChildrens 3 in 1 CARTON TABLET, CHEWABLE 3 16
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 41163-585 ALLERGY RELIEF CHILDRENS (DIPHENHYDRAMINE HCL) TABLET, CHEWABLE [UNITED NATURAL FOODS, INC. DBA UNFI] 15 Current NDC, Legacy NDC, 2 package rows 20240927_e34d8bf5-e12e-453c-93ea-9c7988c4f13d.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 · 3,551 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 41163-585-44 41163058544 3 BLISTER PACK in 1 CARTON (41163-585-44) / 6 TABLET, CHEWABLE in 1 BLISTER PACK 3 blister pack 2009-03-20 2027-04-30 No No Current