Package 58657-504-08
Brand: guaifenesin and dextromethorphan hydrobromide
Generic: guaifenesin and dextromethorphan hydrobromidePackage Facts
Identity
Package NDC
58657-504-08
Digits Only
5865750408
Product NDC
58657-504
Description
237 mL in 1 BOTTLE, PLASTIC (58657-504-08)
Marketing
Marketing Status
Brand
guaifenesin and dextromethorphan hydrobromide
Generic
guaifenesin and dextromethorphan hydrobromide
Sample Package
No
Linked Drug Pages (1)
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"}