Home NDC 63824-250 Mucinex Sinus-Max
Product NDC 63824-250
11-digit product format 638240250
Labeler code 63824
Product ID 63824-250_51b4bf02-1e4f-7b8f-e063-6294a90a678e
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, and Phenylephrine Hydrochloride
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Reckitt Benckiser LLC
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2018-11-15
Substance ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
Active strength 325; 10; 200; 5 mg/1; mg/1; ug/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 Sinus-Max
Brand name suffix Pressure, Pain and Cough
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ACETAMINOPHEN 325 mg/1 DEXTROMETHORPHAN HYDROBROMIDE 10 mg/1 GUAIFENESIN 200 ug/1 PHENYLEPHRINE HYDROCHLORIDE 5 mg/1
Harmonized Identifiers# Field, Values table Field Values Unii 362O9ITL9D, 9D2RTI9KYH, 495W7451VQ, 04JA59TNSJ
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 63824-250-01 Mucinex Sinus-MaxPressure, Pain and Cough 2 in 1 CARTON TABLET, FILM COATED 2 4 63824-250-01 Mucinex Sinus-MaxPressure, Pain and Cough 10 in 1 BLISTER PACK TABLET, FILM COATED 10 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63824-250 MUCINEX SINUS-MAX PRESSURE, PAIN AND COUGH (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) TABLET, FILM COATED [RB HEALTH (US) LLC] 3 Current NDC, Legacy NDC, 2 package rows 20241222_8905706b-b9da-4520-8cf2-87d7c125edf3.zip
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 63824-250-01 63824025001 2 BLISTER PACK in 1 CARTON (63824-250-01) / 10 TABLET, FILM COATED in 1 BLISTER PACK 2 blister pack 2018-11-15 0000-00-00 No No Current