Home NDC 72854-161 Mucinex Fast-Max Cold and Flu
Product NDC 72854-161
11-digit product format 728540161
Labeler code 72854
Product ID 72854-161_5e31e604-3344-b6ce-e063-6294a90a4ded
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen, Dextromethorphan Hydrobromide
Dosage form TABLET
Route ORAL
Labeler Reckitt Benckiser LLC
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2025-04-01
Substance ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE
Active strength 325; 10 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 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 Cold and Flu
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ACETAMINOPHEN 325 mg/1 DEXTROMETHORPHAN HYDROBROMIDE 10 mg/1
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 72854-161-02 Mucinex Fast-Max Cold and Flu 2 in 1 POUCH TABLET 2 2 72854-161-04 Mucinex Fast-Max Cold and Flu 2 in 1 CARTON TABLET 2 2 72854-161-04 Mucinex Fast-Max Cold and Flu 2 in 1 POUCH TABLET 2 2 72854-161-10 Mucinex Fast-Max Cold and Flu 10 in 1 BLISTER PACK TABLET 10 2 72854-161-10 Mucinex Fast-Max Cold and Flu 1 in 1 CARTON TABLET 1 2 72854-161-20 Mucinex Fast-Max Cold and Flu 10 in 1 BLISTER PACK TABLET 10 2 72854-161-20 Mucinex Fast-Max Cold and Flu 2 in 1 CARTON TABLET 2 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 72854-161 MUCINEX FAST-MAX COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE) TABLET [RB HEALTH (US) LLC] 1 Current NDC, 7 package rows 20250403_31ac6883-ffcd-39de-e063-6294a90a52dd.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 72854-161-02 72854016102 2 TABLET in 1 POUCH (72854-161-02) 2 tablet 2025-04-01 No No Current 72854-161-04 72854016104 2 POUCH in 1 CARTON (72854-161-04) / 2 TABLET in 1 POUCH 2 pouch 2025-04-01 No No Current 72854-161-10 72854016110 1 BLISTER PACK in 1 CARTON (72854-161-10) / 10 TABLET in 1 BLISTER PACK 1 blister pack 2025-04-01 No No Current 72854-161-20 72854016120 2 BLISTER PACK in 1 CARTON (72854-161-20) / 10 TABLET in 1 BLISTER PACK 2 blister pack 2025-04-01 No No Current