Home NDC 72854-267 MUCINEX INSTASOOTHE
Product NDC 72854-267
11-digit product format 728540267
Labeler code 72854
Product ID 72854-267_582c85e6-2982-ef3b-e063-6394a90a383a
Type HUMAN OTC DRUG
Nonproprietary name DEXTROMETHORPHAN HYDROBROMIDE
Dosage form LOZENGE
Route ORAL
Labeler Reckitt Benckiser LLC
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-04-01
Substance DEXTROMETHORPHAN HYDROBROMIDE
Active strength 5 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 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 INSTASOOTHE
Brand name suffix COUGH
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DEXTROMETHORPHAN HYDROBROMIDE 5 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 1370219 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 72854-267-20 MUCINEX INSTASOOTHECOUGH 1 in 1 POUCH LOZENGE 1 4 72854-267-20 MUCINEX INSTASOOTHECOUGH 20 in 1 BAG LOZENGE 20 4 72854-267-40 MUCINEX INSTASOOTHECOUGH 1 in 1 POUCH LOZENGE 1 4 72854-267-40 MUCINEX INSTASOOTHECOUGH 40 in 1 BAG LOZENGE 40 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 72854-267 MUCINEX INSTASOOTHE COUGH (DEXTROMETHORPHAN HYDROBROMIDE) LOZENGE [RB HEALTH (US) LLC] 3 Current NDC, 4 package rows 20250410_0d99237c-0b52-0af6-e063-6394a90aba14.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 72854-267-20 72854026720 20 POUCH in 1 BAG (72854-267-20) / 1 LOZENGE in 1 POUCH 20 pouch 2024-04-01 No No Current 72854-267-40 72854026740 40 POUCH in 1 BAG (72854-267-40) / 1 LOZENGE in 1 POUCH 40 pouch 2024-04-01 No No Current