Home NDC 72854-082 Mucinex Childrens Mighty Chews Cough Nighttime
Product NDC 72854-082
11-digit product format 728540082
Labeler code 72854
Product ID 72854-082_531e853d-03ed-6e23-e063-6294a90afb0f
Type HUMAN OTC DRUG
Nonproprietary name Dextromethorphan HBr and Doxylamine Succinate
Dosage form TABLET, CHEWABLE
Route ORAL
Labeler Reckitt Benckiser LLC
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-06-03
Substance DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE
Active strength 10; 6.25 mg/1; mg/1
Pharmacologic classes Antihistamine [EPC], Histamine Receptor Antagonists [MoA], 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 Mighty Chews Cough Nighttime
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DEXTROMETHORPHAN HYDROBROMIDE 10 mg/1 DOXYLAMINE SUCCINATE 6.25 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 9D2RTI9KYH Internal UNII lookup V9BI9B5YI2 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2683423 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 72854-082-16 Mucinex Childrens Mighty Chews Cough Daytime and Nighttime Combo Pack 16 in 1 BOTTLE TABLET, CHEWABLE 16 6.25 mg 3 72854-082-16 Mucinex Childrens Mighty Chews Cough Nighttime 16 in 1 BOTTLE TABLET, CHEWABLE 16 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 72854-082 MUCINEX CHILDRENS MIGHTY CHEWS COUGH DAYTIME AND NIGHTTIME COMBO PACK (DEXTROMETHORPHAN HBR AND DOXYLAMINE SUCCINATE) KIT [RB HEALTH (US) LLC] 2 Current NDC 20241121_16637d54-8049-d3ce-e063-6394a90aafc9.zip 72854-082 MUCINEX CHILDRENS MIGHTY CHEWS COUGH NIGHTTIME (DEXTROMETHORPHAN HBR AND DOXYLAMINE SUCCINATE) TABLET, CHEWABLE [RB HEALTH (US) LLC] 1 Current NDC, 1 package rows 20240603_156033ae-b16a-007b-e063-6294a90a7445.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 74 of 180 · 3,583 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 72854-082-16 72854008216 16 TABLET, CHEWABLE in 1 BOTTLE (72854-082-16) 2024-06-03 No No Current