Home NDC 72854-064 Mucinex Childrens Fever Sore Throat and Cough
Product NDC 72854-064
11-digit product format 728540064
Labeler code 72854
Product ID 72854-064_521a6749-00e2-9ddc-e063-6294a90a909a
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen, Dextromethorphan Hydrobromide
Dosage form SOLUTION
Route ORAL
Labeler Reckitt Benckiser LLC
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-05-01
Substance ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE
Active strength 325; 10 mg/10mL; mg/10mL
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 Mucinex Childrens Fever Sore Throat and Cough
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ACETAMINOPHEN 325 mg/10mL DEXTROMETHORPHAN HYDROBROMIDE 10 mg/10mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 362O9ITL9D Internal UNII lookup 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 1919076 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 72854-064-04 Mucinex Childrens Fever Sore Throat and Cough 118 mL in 1 BOTTLE SOLUTION 118 2 72854-064-04 Mucinex Childrens Fever Sore Throat and Cough 1 in 1 CARTON SOLUTION 1 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 72854-064 MUCINEX CHILDRENS FEVER SORE THROAT AND COUGH (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE) SOLUTION [RB HEALTH (US) LLC] 1 Current NDC, 2 package rows 20240501_1538a75d-582a-9501-e063-6394a90a6c55.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 72854-064-04 72854006404 1 BOTTLE in 1 CARTON (72854-064-04) / 118 mL in 1 BOTTLE 1 bottle 2024-05-01 No No Current