Home NDC 83324-134 Adult Cough Relief
Product NDC 83324-134
11-digit product format 833240134
Labeler code 83324
Product ID 83324-134_8bae585a-98a5-4e7b-8dab-6ff4c19c04ba
Type HUMAN OTC DRUG
Nonproprietary name Dextromethorphan HBr
Dosage form LIQUID
Route ORAL
Labeler QUALITY CHOICE (Chain Drug Marketing Association)
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-07-31
Substance DEXTROMETHORPHAN HYDROBROMIDE
Active strength 15 mg/5mL
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 2027-12-31
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 Adult Cough Relief
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DEXTROMETHORPHAN HYDROBROMIDE 15 mg/5mL
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 1090496 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 83324-134-04 Adult Cough Relief 1 in 1 BOX LIQUID 1 2 83324-134-04 Adult Cough Relief 118 mL in 1 BOTTLE, PLASTIC LIQUID 118 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 83324-134 ADULT COUGH RELIEF (DEXTROMETHORPHAN HBR) LIQUID [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)] 2 Current NDC, 2 package rows 20240731_6e35f30d-9b29-4468-9f5e-1ee2e9ac4b8c.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 Marketing start Sample Exclude flag Status 83324-134-04 83324013404 1 BOTTLE, PLASTIC in 1 BOX (83324-134-04) / 118 mL in 1 BOTTLE, PLASTIC 2024-07-31 No No Current