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 GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE
Active strength 200; 5; 10 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 · 6 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…
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 Severe Congestion and Cough
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength GUAIFENESIN 200 mg/1 PHENYLEPHRINE HYDROCHLORIDE 5 mg/1 DEXTROMETHORPHAN HYDROBROMIDE 10 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 495W7451VQ Internal UNII lookup 04JA59TNSJ Internal UNII lookup 9D2RTI9KYH Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1372652 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
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
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 74 of 180 · 3,583 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 63824-515-01 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