Home NDC 63824-515 Mucinex Fast-Max
Product NDC 63824-515
11-digit product format 638240515
Labeler code 63824
Product ID 63824-515_51b45cdb-42b6-7a6f-e063-6294a90a5039
Type HUMAN OTC DRUG
Nonproprietary name Guaifenesin, Phenylephrine Hydrochloride, and Dextromethorphan Hydrobromide
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Reckitt Benckiser LLC
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2018-08-01
Substance DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
Active strength 10; 200; 5 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 Additional Listing Data#
Finished product Yes
Brand name base Mucinex Fast-Max
Brand name suffix Severe Congestion and Cough
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DEXTROMETHORPHAN HYDROBROMIDE 10 mg/1 GUAIFENESIN 200 mg/1 PHENYLEPHRINE HYDROCHLORIDE 5 mg/1
Harmonized Identifiers# Field, Values table Field Values Unii 9D2RTI9KYH, 495W7451VQ, 04JA59TNSJ Rxcui 1372652
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 63824-515-01 Mucinex Fast-MaxSevere Congestion and Cough 10 in 1 BLISTER PACK TABLET, FILM COATED 10 8 63824-515-01 Mucinex Fast-MaxSevere Congestion and Cough 2 in 1 CARTON TABLET, FILM COATED 2 8 63824-515-20 Mucinex Fast-MaxSevere Congestion and Cough 5 in 1 BLISTER PACK TABLET, FILM COATED 5 8 63824-515-20 Mucinex Fast-MaxSevere Congestion and Cough 4 in 1 CARTON TABLET, FILM COATED 4 8
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63824-515 MUCINEX FAST-MAX SEVERE CONGESTION AND COUGH (GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, AND DEXTROMETHORPHAN HYDROBROMIDE) TABLET, FILM COATED [RB HEALTH (US) LLC] 7 Current NDC, Legacy NDC, 4 package rows 20231202_1991d5ee-fc90-4070-8965-cd6f4abc45cf.zip
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 63824-515-01 63824051501 2 BLISTER PACK in 1 CARTON (63824-515-01) > 10 TABLET, FILM COATED in 1 BLISTER PACK 2 blister pack 2018-08-01 0000-00-00 No No Current 63824-515-20 63824051520 4 BLISTER PACK in 1 CARTON (63824-515-20) / 5 TABLET, FILM COATED in 1 BLISTER PACK 4 blister pack 2024-01-01 No No Current