Home NDC 81522-109 Allergy Relief
Product NDC 81522-109
11-digit product format 815220109
Labeler code 81522
Product ID 81522-109_24999d88-1a63-7029-e063-6394a90ad4a9
Type HUMAN OTC DRUG
Nonproprietary name DIPHENHYDRAMINE HYDROCHLORIDE
Dosage form TABLET, COATED
Route ORAL
Labeler FSA STORE INC.
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2023-01-11
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 2026-12-31
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 2026-12-31 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 1049630 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 81522-109-03 Allergy Relief 1 in 1 CARTON TABLET, COATED 1 3 81522-109-03 Allergy Relief 100 in 1 BOTTLE, PLASTIC TABLET, COATED 100 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 81522-109 ALLERGY RELIEF (DIPHENHYDRAMINE HYDROCHLORIDE) TABLET, COATED [FSA STORE INC.] 3 Current NDC, Legacy NDC, 2 package rows 20241018_ec6aef90-ece1-4fe6-e053-2995a90a9310.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 Marketing start Marketing end Sample Exclude flag Status 81522-109-03 81522010903 1 BOTTLE, PLASTIC in 1 CARTON (81522-109-03) / 100 TABLET, COATED in 1 BOTTLE, PLASTIC 2023-01-11 0000-00-00 No No Current