robafen dm cough

Generic: dextromethorphan hbr, guaifenesin

Labeler: major pharmaceuticals
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name robafen dm cough
Generic Name dextromethorphan hbr, guaifenesin
Labeler major pharmaceuticals
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

dextromethorphan hydrobromide 20 mg/20mL, guaifenesin 200 mg/20mL

Manufacturer
Major Pharmaceuticals

Identifiers & Regulatory

Product NDC 0904-7441
Product ID 0904-7441_dbd87cb4-742b-4e03-8dbc-4914e8cdfd8b
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2027-12-31
Marketing Start 2024-04-05

Pharmacologic Class

Established (EPC)
expectorant [epc]
Physiologic Effect
decreased respiratory secretion viscosity [pe] increased respiratory secretions [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 09047441
Hyphenated Format 0904-7441

Supplemental Identifiers

RxCUI
1790650
UPC
0309047441204
UNII
9D2RTI9KYH 495W7451VQ
NUI
N0000193956 N0000008867 N0000009560

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name robafen dm cough (source: ndc)
Generic Name dextromethorphan hbr, guaifenesin (source: ndc)
Application Number M012 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/20mL
  • 200 mg/20mL
source: ndc
Packaging
  • 1 BOTTLE, PLASTIC in 1 CARTON (0904-7441-20) / 118 mL in 1 BOTTLE, PLASTIC
source: ndc

Packages (1)

0904-7441-20 1 BOTTLE, PLASTIC in 1 CARTON (0904-7441-20) / 118 mL in 1 BOTTLE, PLASTIC

Ingredients (2)

dextromethorphan hydrobromide (20 mg/20mL) guaifenesin (200 mg/20mL)

Linked Drug Pages (1)

Robafen DM Cough ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "dbd87cb4-742b-4e03-8dbc-4914e8cdfd8b", "openfda": {"nui": ["N0000193956", "N0000008867", "N0000009560"], "upc": ["0309047441204"], "unii": ["9D2RTI9KYH", "495W7451VQ"], "rxcui": ["1790650"], "spl_set_id": ["7c9660b7-cb00-449b-b65f-aa42d8ce1942"], "pharm_class_pe": ["Decreased Respiratory Secretion Viscosity [PE]", "Increased Respiratory Secretions [PE]"], "pharm_class_epc": ["Expectorant [EPC]"], "manufacturer_name": ["Major Pharmaceuticals"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, PLASTIC in 1 CARTON (0904-7441-20)  / 118 mL in 1 BOTTLE, PLASTIC", "package_ndc": "0904-7441-20", "marketing_start_date": "20240405"}], "brand_name": "Robafen DM Cough", "product_id": "0904-7441_dbd87cb4-742b-4e03-8dbc-4914e8cdfd8b", "dosage_form": "SOLUTION", "pharm_class": ["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]"], "product_ndc": "0904-7441", "generic_name": "Dextromethorphan HBr, Guaifenesin", "labeler_name": "Major Pharmaceuticals", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Robafen DM Cough", "active_ingredients": [{"name": "DEXTROMETHORPHAN HYDROBROMIDE", "strength": "20 mg/20mL"}, {"name": "GUAIFENESIN", "strength": "200 mg/20mL"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20240405", "listing_expiration_date": "20271231"}