Home NDC 0904-7441 Robafen DM Cough
Product NDC 0904-7441
11-digit product format 009047441
Labeler code 0904
Product ID 0904-7441_dbd87cb4-742b-4e03-8dbc-4914e8cdfd8b
Type HUMAN OTC DRUG
Nonproprietary name Dextromethorphan HBr, Guaifenesin
Dosage form SOLUTION
Route ORAL
Labeler Major Pharmaceuticals
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-04-05
Substance DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
Active strength 20; 200 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 Robafen DM Cough
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DEXTROMETHORPHAN HYDROBROMIDE 20 mg/20mL GUAIFENESIN 200 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 1790650 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 0904-7441-20 Robafen DM Cough 1 in 1 CARTON SOLUTION 1 3 0904-7441-20 Robafen DM Cough 118 mL in 1 BOTTLE, PLASTIC SOLUTION 118 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0904-7441 ROBAFEN DM COUGH (DEXTROMETHORPHAN HBR, GUAIFENESIN) SOLUTION [MAJOR PHARMACEUTICALS] 2 Current NDC, 2 package rows 20250413_7c9660b7-cb00-449b-b65f-aa42d8ce1942.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 Marketing start Sample Exclude flag Status 0904-7441-20 00904744120 1 BOTTLE, PLASTIC in 1 CARTON (0904-7441-20) / 118 mL in 1 BOTTLE, PLASTIC 2024-04-05 No No Current