robafen dm

Generic: dextromethorphan hydrobromide, guaifenesin

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

Drug Facts

Product Profile

Brand Name robafen dm
Generic Name dextromethorphan hydrobromide, 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 0904-7223
Product ID 0904-7223_72399607-018b-48dd-b1c7-44fecd14be5b
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2027-12-31
Marketing Start 2022-01-07

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 09047223
Hyphenated Format 0904-7223

Supplemental Identifiers

RxCUI
1790650
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 (source: ndc)
Generic Name dextromethorphan hydrobromide, 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 in 1 CARTON (0904-7223-20) / 118 mL in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (0904-7223-59) / 237 mL in 1 BOTTLE
source: ndc

Packages (2)

0904-7223-20 1 BOTTLE in 1 CARTON (0904-7223-20) / 118 mL in 1 BOTTLE 0904-7223-59 1 BOTTLE in 1 CARTON (0904-7223-59) / 237 mL in 1 BOTTLE

Ingredients (2)

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

Linked Drug Pages (1)

robafen dm ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "72399607-018b-48dd-b1c7-44fecd14be5b", "openfda": {"nui": ["N0000193956", "N0000008867", "N0000009560"], "unii": ["9D2RTI9KYH", "495W7451VQ"], "rxcui": ["1790650"], "spl_set_id": ["5e19220d-9cf3-4732-b9aa-c09db5d69ce6"], "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 in 1 CARTON (0904-7223-20)  / 118 mL in 1 BOTTLE", "package_ndc": "0904-7223-20", "marketing_start_date": "20220107"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (0904-7223-59)  / 237 mL in 1 BOTTLE", "package_ndc": "0904-7223-59", "marketing_start_date": "20220124"}], "brand_name": "robafen dm", "product_id": "0904-7223_72399607-018b-48dd-b1c7-44fecd14be5b", "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": "0904-7223", "generic_name": "dextromethorphan hydrobromide, guaifenesin", "labeler_name": "Major Pharmaceuticals", "product_type": "HUMAN OTC DRUG", "brand_name_base": "robafen dm", "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": "20220107", "listing_expiration_date": "20271231"}