Home NDC 67091-425 Allergy Relief
Product NDC 67091-425
11-digit product format 670910425
Labeler code 67091
Product ID 67091-425_e55e7a67-ccc5-48ae-a8aa-0f2b232a4c2d
Type HUMAN OTC DRUG
Nonproprietary name Diphenhydramine HCl
Dosage form TABLET, CHEWABLE
Route ORAL
Labeler WinCo Foods, LLC
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-03-28
Marketing end 2027-07-31
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 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 67091-425-20 Allergy Relief 4 in 1 CARTON TABLET, CHEWABLE 4 3 67091-425-20 Allergy Relief 5 in 1 BLISTER PACK TABLET, CHEWABLE 5 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 67091-425 ALLERGY RELIEF (DIPHENHYDRAMINE HCL) TABLET, CHEWABLE [WINCO FOODS, LLC] 2 Current NDC, 2 package rows 20240828_2cbf27b6-217c-46d8-89c9-e46f3668f002.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 Marketing end Sample Exclude flag Status 67091-425-20 67091042520 4 BLISTER PACK in 1 CARTON (67091-425-20) / 5 TABLET, CHEWABLE in 1 BLISTER PACK 4 blister pack 2024-03-28 2027-07-31 No No Historical