Home NDC 63824-237 Mucinex Fast-Max
Product NDC 63824-237
11-digit product format 638240237
Labeler code 63824
Product ID 63824-237_51a49ad7-95b0-5066-e063-6294a90ab8a7
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, and Phenylephrine Hydrochloride
Dosage form TABLET, COATED
Route ORAL
Labeler Reckitt Benckiser LLC
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2017-10-01
Substance ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
Active strength 325; 10; 200; 5 mg/1; mg/1; mg/1; mg/1
Pharmacologic classes Adrenergic alpha1-Agonists [MoA], 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], alpha-1 Adrenergic Agonist [EPC]
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
Brand name suffix Cold, Flu and Sore Throat
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ACETAMINOPHEN 325 mg/1 DEXTROMETHORPHAN HYDROBROMIDE 10 mg/1 GUAIFENESIN 200 mg/1 PHENYLEPHRINE HYDROCHLORIDE 5 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 4 matching rows.
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1110988 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 63824-237-20 Mucinex Fast-MaxCold, Flu and Sore Throat 2 in 1 CARTON TABLET, COATED 2 9 63824-237-20 Mucinex Fast-MaxCold, Flu and Sore Throat 10 in 1 BLISTER PACK TABLET, COATED 10 9 63824-237-21 Mucinex Fast-MaxCold, Flu and Sore Throat 10 in 1 BLISTER PACK TABLET, COATED 10 9 63824-237-21 Mucinex Fast-MaxCold, Flu and Sore Throat 2 in 1 CARTON TABLET, COATED 2 9 63824-237-44 Mucinex Fast-MaxCold, Flu and Sore Throat 4 in 1 CARTON TABLET, COATED 4 9 63824-237-72 Mucinex Fast-MaxCold, Flu and Sore Throat 2 in 1 POUCH TABLET, COATED 2 9
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63824-237 MUCINEX FAST-MAX COLD, FLU AND SORE THROAT (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, COATED [RB HEALTH (US) LLC] 8 Current NDC, Legacy NDC, 6 package rows 20241222_d7c18e95-8d7b-4550-9a20-fc704a114adb.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 Marketing end Sample Exclude flag Status 63824-237-20 63824023720 2 BLISTER PACK in 1 CARTON (63824-237-20) / 10 TABLET, COATED in 1 BLISTER PACK 2 blister pack 2017-10-01 0000-00-00 No No Current 63824-237-21 63824023721 2 BLISTER PACK in 1 CARTON (63824-237-21) / 10 TABLET, COATED in 1 BLISTER PACK 2 blister pack 2020-10-01 0000-00-00 No No Current 63824-237-44 63824023744 4 POUCH in 1 CARTON (63824-237-44) / 2 TABLET, COATED in 1 POUCH (63824-237-72) 4 pouch 2017-12-20 0000-00-00 No No Current 63824-237-72 63824023772 2 in 1 POUCH Historical