Home NDC 63824-535 Mucinex Fast-Max DM Max Honey and Berry Flavor
Product NDC 63824-535
11-digit product format 638240535
Labeler code 63824
Product ID 63824-535_59579ec9-f9da-4397-e063-6394a90ac4a0
Type HUMAN OTC DRUG
Nonproprietary name Dextromethorphan Hydrobromide and Guaifenesin
Dosage form SOLUTION
Route ORAL
Labeler Reckitt Benckiser LLC
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2020-06-01
Substance DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
Active strength 20; 400 mg/20mL; mg/20mL
Pharmacologic classes 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]
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 DM Max Honey and Berry Flavor
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DEXTROMETHORPHAN HYDROBROMIDE 20 mg/20mL GUAIFENESIN 400 mg/20mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 9D2RTI9KYH Internal UNII lookup 495W7451VQ Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1020138 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 63824-535-66 Mucinex Fast-Max DM Max Honey and Berry Flavor 180 mL in 1 BOTTLE SOLUTION 180 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63824-535 MUCINEX FAST-MAX DM MAX HONEY AND BERRY FLAVOR (DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN) SOLUTION [RB HEALTH (US) LLC] 4 Current NDC, Legacy NDC, 1 package rows 20240719_da1f1ef9-a974-4998-8e1d-c1d999596943.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 97 of 178 · 3,550 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 63824-535-66 63824053566 180 mL in 1 BOTTLE (63824-535-66) 180 ml 2020-06-01 0000-00-00 No No Current