Home NDC 83324-303 QUALITY CHOICE Long Acting Cough Softgel
Product NDC 83324-303
11-digit product format 833240303
Labeler code 83324
Product ID 83324-303_b9864639-8295-437e-bcba-e7cc9fce1a30
Type HUMAN OTC DRUG
Nonproprietary name Dextromethorphan hydrobromide
Dosage form CAPSULE, LIQUID FILLED
Route ORAL
Labeler Chain Drug Marketing Association, Inc.
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-08-16
Substance DEXTROMETHORPHAN HYDROBROMIDE
Active strength 15 mg/1
Pharmacologic classes Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]
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 Long Acting Cough Softgel
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DEXTROMETHORPHAN HYDROBROMIDE 15 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 9D2RTI9KYH Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1090487 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 83324-303-20 QUALITY CHOICE Long Acting Cough Softgel 20 in 1 BOTTLE CAPSULE, LIQUID FILLED 20 1 83324-303-20 QUALITY CHOICE Long Acting Cough Softgel 1 in 1 CARTON CAPSULE, LIQUID FILLED 1 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 83324-303 QUALITY CHOICE LONG ACTING COUGH SOFTGEL (DEXTROMETHORPHAN HYDROBROMIDE) CAPSULE, LIQUID FILLED [CHAIN DRUG MARKETING ASSOCIATION, INC.] 1 Current NDC, 2 package rows 20240828_f1ea7dfc-c605-45a1-ad1d-6e636a8a7b1c.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 177 · 3,534 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 83324-303-20 83324030320 1 BOTTLE in 1 CARTON (83324-303-20) / 20 CAPSULE, LIQUID FILLED in 1 BOTTLE 1 bottle 2024-08-16 No No Current