Home NDC 50844-633 Mucus Relief DM Cough
Product NDC 50844-633
11-digit product format 508440633
Labeler code 50844
Product ID 50844-633_149a0797-addc-4029-b646-5ce00b50664e
Type HUMAN OTC DRUG
Nonproprietary name Dextromethorphan HBr and Guaifenesin
Dosage form TABLET, FILM COATED
Route ORAL
Labeler L.N.K. International, Inc.
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2023-08-07
Substance DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
Active strength 20; 400 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 Mucus Relief DM Cough
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DEXTROMETHORPHAN HYDROBROMIDE 20 mg/1 GUAIFENESIN 400 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 1147685 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 50844-633-11 Mucus Relief DM Cough 60 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 60 5 50844-633-11 Mucus Relief DM Cough 1 in 1 CARTON TABLET, FILM COATED 1 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50844-633 MUCUS RELIEF DM COUGH (DEXTROMETHORPHAN HBR AND GUAIFENESIN) TABLET, FILM COATED [L.N.K. INTERNATIONAL, INC.] 4 Current NDC, 2 package rows 20250418_2fea3533-8218-4875-affe-5b33a22c553a.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 98 of 180 · 3,583 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 50844-633-11 50844063311 1 BOTTLE, PLASTIC in 1 CARTON (50844-633-11) / 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC 2023-08-07 No No Current