Home NDC 72854-084 Mucinex Childrens Mighty Chews Cold and Flu
Product NDC 72854-084
11-digit product format 728540084
Labeler code 72854
Product ID 72854-084_2ce1fc99-1f89-adb8-e063-6394a90a53a1
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen and Dextromethorphan Hydrobromide
Dosage form TABLET, CHEWABLE
Route ORAL
Labeler RB Health (US) LLC
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2025-06-01
Substance ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE
Active strength 162.5; 15 mg/1; 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 Mucinex Childrens Mighty Chews Cold and Flu
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ACETAMINOPHEN 162.5 mg/1 DEXTROMETHORPHAN HYDROBROMIDE 15 mg/1
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 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 72854-084-16 Mucinex Childrens Mighty Chews Cold and Flu 16 in 1 BOTTLE TABLET, CHEWABLE 16 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 73 of 178 · 3,551 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 72854-084-16 72854008416 16 TABLET, CHEWABLE in 1 BOTTLE (72854-084-16) 2025-06-01 No No Current