Home NDC 63824-943 Mucinex Childrens
Product NDC 63824-943
11-digit product format 638240943
Labeler code 63824
Product ID 63824-943_51a4f960-294a-48c2-e063-6394a90a3ff2
Type HUMAN OTC DRUG
Nonproprietary name Dextromethorphan Hydrobromide and Guaifenesin
Dosage form GRANULE
Route ORAL
Labeler Reckitt Benckiser LLC
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2022-01-27
Substance DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
Active strength 5; 100 mg/1; mg/1
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 Childrens
Brand name suffix Cough and Chest Congestion Mini-Melts Orange Creme
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DEXTROMETHORPHAN HYDROBROMIDE 5 mg/1 GUAIFENESIN 100 mg/1
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 2122356 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 63824-943-02 Mucinex ChildrensCough and Chest Congestion Mini-Melts Orange Creme 1 in 1 PACKET GRANULE 1 3 63824-943-02 Mucinex ChildrensCough and Chest Congestion Mini-Melts Orange Creme 2 in 1 PACKAGE GRANULE 2 3 63824-943-12 Mucinex ChildrensCough and Chest Congestion Mini-Melts Orange Creme 12 in 1 CARTON GRANULE 12 3 63824-943-12 Mucinex ChildrensCough and Chest Congestion Mini-Melts Orange Creme 1 in 1 PACKET GRANULE 1 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63824-943 MUCINEX CHILDRENS COUGH AND CHEST CONGESTION MINI-MELTS ORANGE CREME (DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN) GRANULE [RB HEALTH (US) LLC] 2 Current NDC, Legacy NDC, 4 package rows 20241220_66543190-1d3d-4259-ae73-d366ecbf9e52.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 63824-943-02 63824094302 2 PACKET in 1 PACKAGE (63824-943-02) / 1 GRANULE in 1 PACKET 2 packet 2022-01-27 0000-00-00 Yes No Current 63824-943-12 63824094312 12 PACKET in 1 CARTON (63824-943-12) / 1 GRANULE in 1 PACKET 12 packet 2022-01-27 0000-00-00 No No Current