Home NDC 72854-153 Mucinex Fast-Max Severe Congestion and Cough
Product NDC 72854-153
11-digit product format 728540153
Labeler code 72854
Product ID 72854-153_521aa0f2-d86d-b1ba-e063-6294a90ad3df
Type HUMAN OTC DRUG
Nonproprietary name Dextromethorphan Hydrobromide, Guaifenesin
Dosage form CAPSULE, LIQUID FILLED
Route ORAL
Labeler Reckitt Benckiser LLC
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-06-01
Substance DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
Active strength 10; 200 mg/1; mg/1
Pharmacologic classes Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], 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 Fast-Max Severe Congestion and Cough
Brand name suffix Maximum Strength
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DEXTROMETHORPHAN HYDROBROMIDE 10 mg/1 GUAIFENESIN 200 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 495W7451VQ Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1111663 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 72854-153-16 Mucinex Fast-Max Severe Congestion and CoughMaximum Strength 8 in 1 BLISTER PACK CAPSULE, LIQUID FILLED 8 3 72854-153-16 Mucinex Fast-Max Severe Congestion and CoughMaximum Strength 2 in 1 CARTON CAPSULE, LIQUID FILLED 2 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 72854-153 MUCINEX FAST-MAX SEVERE CONGESTION AND COUGH MAXIMUM STRENGTH (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) CAPSULE, LIQUID FILLED [RB HEALTH (US) LLC] 1 Current NDC, 2 package rows 20240601_14be3ab0-d6ae-e342-e063-6294a90ab851.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 Units Marketing start Sample Exclude flag Status 72854-153-16 72854015316 2 BLISTER PACK in 1 CARTON (72854-153-16) / 8 CAPSULE, LIQUID FILLED in 1 BLISTER PACK 2 blister pack 2024-06-01 No No Current