Home NDC 83324-339 QUALITY CHOICE
Product NDC 83324-339
11-digit product format 833240339
Labeler code 83324
Product ID 83324-339_3cf1c37f-5278-d410-e063-6394a90a4132
Type HUMAN OTC DRUG
Nonproprietary name Diphenhydramine hydrochloride
Dosage form SOLUTION
Route ORAL
Labeler QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2025-08-01
Substance DIPHENHYDRAMINE HYDROCHLORIDE
Active strength 12.5 mg/5mL
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 QUALITY CHOICE
Brand name suffix Childrens Allergy Relief DYE FREE
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DIPHENHYDRAMINE HYDROCHLORIDE 12.5 mg/5mL
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 1049906 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 83324-339-04 QUALITY CHOICEChildrens Allergy Relief DYE FREE 1 in 1 CARTON SOLUTION 1 1 83324-339-04 QUALITY CHOICEChildrens Allergy Relief DYE FREE 118 mL in 1 BOTTLE, PLASTIC SOLUTION 118 1
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 97 of 178 · 3,551 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 83324-339-04 83324033904 1 BOTTLE, PLASTIC in 1 CARTON (83324-339-04) / 118 mL in 1 BOTTLE, PLASTIC 2025-08-01 No No Current