guaifenesin and dextromethorphan hydrobromide

Generic: guaifenesin and dextromethorphan hydrobromide

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

Drug Facts

Product Profile

Brand Name guaifenesin and dextromethorphan hydrobromide
Generic Name guaifenesin and dextromethorphan hydrobromide
Labeler method pharmaceuticals
Dosage Form SYRUP
Routes
ORAL
Active Ingredients

dextromethorphan hydrobromide 10 mg/5mL, guaifenesin 100 mg/5mL

Manufacturer
Method Pharmaceuticals

Identifiers & Regulatory

Product NDC 58657-504
Product ID 58657-504_41b4eb73-e463-24b0-e063-6394a90a6cc0
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2026-12-31
Marketing Start 2024-04-01

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 58657504
Hyphenated Format 58657-504

Supplemental Identifiers

RxCUI
996520
UPC
0358657504083
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 guaifenesin and dextromethorphan hydrobromide (source: ndc)
Generic Name guaifenesin and dextromethorphan hydrobromide (source: ndc)
Application Number M012 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/5mL
  • 100 mg/5mL
source: ndc
Packaging
  • 237 mL in 1 BOTTLE, PLASTIC (58657-504-08)
source: ndc

Packages (1)

58657-504-08 237 mL in 1 BOTTLE, PLASTIC (58657-504-08)

Ingredients (2)

dextromethorphan hydrobromide (10 mg/5mL) guaifenesin (100 mg/5mL)

Linked Drug Pages (1)

Guaifenesin and Dextromethorphan Hydrobromide ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "41b4eb73-e463-24b0-e063-6394a90a6cc0", "openfda": {"nui": ["N0000193956", "N0000008867", "N0000009560"], "upc": ["0358657504083"], "unii": ["9D2RTI9KYH", "495W7451VQ"], "rxcui": ["996520"], "spl_set_id": ["1538bf63-d020-3ba2-e063-6294a90aecc5"], "pharm_class_pe": ["Decreased Respiratory Secretion Viscosity [PE]", "Increased Respiratory Secretions [PE]"], "pharm_class_epc": ["Expectorant [EPC]"], "manufacturer_name": ["Method Pharmaceuticals"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "237 mL in 1 BOTTLE, PLASTIC (58657-504-08)", "package_ndc": "58657-504-08", "marketing_start_date": "20240401"}], "brand_name": "Guaifenesin and Dextromethorphan Hydrobromide", "product_id": "58657-504_41b4eb73-e463-24b0-e063-6394a90a6cc0", "dosage_form": "SYRUP", "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": "58657-504", "generic_name": "Guaifenesin and Dextromethorphan Hydrobromide", "labeler_name": "Method Pharmaceuticals", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Guaifenesin and Dextromethorphan Hydrobromide", "active_ingredients": [{"name": "DEXTROMETHORPHAN HYDROBROMIDE", "strength": "10 mg/5mL"}, {"name": "GUAIFENESIN", "strength": "100 mg/5mL"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20240401", "listing_expiration_date": "20261231"}