Package 58809-217-08
Brand: texaclear severe cough, cold and flu
Generic: choline salicylate, dextromethorphan hydrobromide, guaifenesinPackage Facts
Identity
Package NDC
58809-217-08
Digits Only
5880921708
Product NDC
58809-217
Description
237 mL in 1 BOTTLE, PLASTIC (58809-217-08)
Marketing
Marketing Status
Brand
texaclear severe cough, cold and flu
Generic
choline salicylate, dextromethorphan hydrobromide, guaifenesin
Sample Package
No
Linked Drug Pages (1)
Raw FDA Data
View complete raw FDA NDC JSON payload
{"route": ["ORAL"], "spl_id": "4080d923-ca5f-bce0-e063-6294a90a96c2", "openfda": {"nui": ["N0000193956", "N0000008867", "N0000009560"], "upc": ["0358809217083"], "unii": ["KD510K1IQW", "9D2RTI9KYH", "495W7451VQ"], "rxcui": ["2670541"], "spl_set_id": ["cb99e5b3-1908-43c9-b31f-d35e7ce58b44"], "pharm_class_pe": ["Decreased Respiratory Secretion Viscosity [PE]", "Increased Respiratory Secretions [PE]"], "pharm_class_epc": ["Expectorant [EPC]"], "manufacturer_name": ["GM Pharmaceuticals, INC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "237 mL in 1 BOTTLE, PLASTIC (58809-217-08)", "package_ndc": "58809-217-08", "marketing_start_date": "20231025"}], "brand_name": "TexaClear Severe Cough, Cold and Flu", "product_id": "58809-217_4080d923-ca5f-bce0-e063-6294a90a96c2", "dosage_form": "LIQUID", "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": "58809-217", "generic_name": "Choline Salicylate, Dextromethorphan Hydrobromide, Guaifenesin", "labeler_name": "GM Pharmaceuticals, INC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "TexaClear Severe Cough, Cold and Flu", "active_ingredients": [{"name": "CHOLINE SALICYLATE", "strength": "870 mg/30mL"}, {"name": "DEXTROMETHORPHAN HYDROBROMIDE", "strength": "20 mg/30mL"}, {"name": "GUAIFENESIN", "strength": "200 mg/30mL"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20231025", "listing_expiration_date": "20261231"}