Home NDC 63824-591 Mucinex Fast-Max
Product NDC 63824-591
11-digit product format 638240591
Labeler code 63824
Product ID 63824-591_51b46950-2d62-8fbc-e063-6294a90a76e6
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen, Dextromethorphan hydrobromide, Guaifenesin, and Phenylephrine Hydrochloride
Dosage form CAPSULE, LIQUID FILLED
Route ORAL
Labeler Reckitt Benckiser LLC
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2015-07-15
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 Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 4 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2022-04-09 23:13 UTC · source 2022-04-08 excluded product product 86f5da6cb304…a595104c45d7…2022-04-09 23:13 UTC · source 2022-04-08 excluded package package 63824-591-16 86f5da6cb304…a595104c45d7…2022-04-04 05:40 UTC · source 2022-04-01 excluded product product bd6a592717d7…303034d00443…2022-04-04 05:40 UTC · source 2022-04-01 excluded package package 63824-591-16 bd6a592717d7…303034d00443…
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 1656815 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 63824-591-16 Mucinex Fast-MaxCold, Flu and Sore Throat 8 in 1 BLISTER PACK CAPSULE, LIQUID FILLED 8 10 63824-591-16 Mucinex Fast-MaxCold, Flu and Sore Throat 2 in 1 CARTON CAPSULE, LIQUID FILLED 2 10
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded Acetaminophen ACTIVE INGREDIENT 362O9ITL9D MUCINEX FAST-MAX COLD, FLU AND SORE THROAT (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [RECKITT BENCKISER LLC] 2 Dextromethorphan hydrobromide ACTIVE INGREDIENT 9D2RTI9KYH MUCINEX FAST-MAX COLD, FLU AND SORE THROAT (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [RECKITT BENCKISER LLC] 2 Guaifenesin ACTIVE INGREDIENT 495W7451VQ MUCINEX FAST-MAX COLD, FLU AND SORE THROAT (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [RECKITT BENCKISER LLC] 2 Phenylephrine Hydrochloride ACTIVE INGREDIENT 04JA59TNSJ MUCINEX FAST-MAX COLD, FLU AND SORE THROAT (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [RECKITT BENCKISER LLC] 2 Acetaminophen ACTIVE MOIETY 362O9ITL9D MUCINEX FAST-MAX COLD, FLU AND SORE THROAT (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [RECKITT BENCKISER LLC] 2 Dextromethorphan ACTIVE MOIETY 7355X3ROTS MUCINEX FAST-MAX COLD, FLU AND SORE THROAT (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [RECKITT BENCKISER LLC] 2 Guaifenesin ACTIVE MOIETY 495W7451VQ MUCINEX FAST-MAX COLD, FLU AND SORE THROAT (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [RECKITT BENCKISER LLC] 2 Phenylephrine ACTIVE MOIETY 1WS297W6MV MUCINEX FAST-MAX COLD, FLU AND SORE THROAT (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [RECKITT BENCKISER LLC] 2 FD&C red no. 40 INACTIVE INGREDIENT WZB9127XOA MUCINEX FAST-MAX COLD, FLU AND SORE THROAT (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [RECKITT BENCKISER LLC] 2 FD&C yellow no. 6 INACTIVE INGREDIENT H77VEI93A8 MUCINEX FAST-MAX COLD, FLU AND SORE THROAT (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [RECKITT BENCKISER LLC] 2 gelatin INACTIVE INGREDIENT 2G86QN327L MUCINEX FAST-MAX COLD, FLU AND SORE THROAT (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [RECKITT BENCKISER LLC] 2 glycerin INACTIVE INGREDIENT PDC6A3C0OX MUCINEX FAST-MAX COLD, FLU AND SORE THROAT (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [RECKITT BENCKISER LLC] 2 lecithin, soybean INACTIVE INGREDIENT 1DI56QDM62 MUCINEX FAST-MAX COLD, FLU AND SORE THROAT (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [RECKITT BENCKISER LLC] 2 mineral oil INACTIVE INGREDIENT T5L8T28FGP MUCINEX FAST-MAX COLD, FLU AND SORE THROAT (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [RECKITT BENCKISER LLC] 2 polyethylene glycols INACTIVE INGREDIENT 3WJQ0SDW1A MUCINEX FAST-MAX COLD, FLU AND SORE THROAT (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [RECKITT BENCKISER LLC] 2 povidones INACTIVE INGREDIENT FZ989GH94E MUCINEX FAST-MAX COLD, FLU AND SORE THROAT (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [RECKITT BENCKISER LLC] 2 propylene glycol INACTIVE INGREDIENT 6DC9Q167V3 MUCINEX FAST-MAX COLD, FLU AND SORE THROAT (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [RECKITT BENCKISER LLC] 2 sorbitol INACTIVE INGREDIENT 506T60A25R MUCINEX FAST-MAX COLD, FLU AND SORE THROAT (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [RECKITT BENCKISER LLC] 2 titanium dioxide INACTIVE INGREDIENT 15FIX9V2JP MUCINEX FAST-MAX COLD, FLU AND SORE THROAT (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [RECKITT BENCKISER LLC] 2 water INACTIVE INGREDIENT 059QF0KO0R MUCINEX FAST-MAX COLD, FLU AND SORE THROAT (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [RECKITT BENCKISER LLC] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63824-591 MUCINEX FAST-MAX COLD, FLU AND SORE THROAT (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [RB HEALTH (US) LLC] 9 Current NDC, Legacy NDC, 2 package rows 20241222_a3523aa3-9ed1-472d-9986-438440d0a3eb.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 63824-591-16 63824059116 2 BLISTER PACK in 1 CARTON (63824-591-16) / 8 CAPSULE, LIQUID FILLED in 1 BLISTER PACK 2 blister pack 2015-07-15 0000-00-00 No No Current