Package 65852-012-04

Brand: giltuss cough and cold

Generic: dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride
NDC Package

Package Facts

Identity

Package NDC 65852-012-04
Digits Only 6585201204
Product NDC 65852-012
Description

1 BOTTLE, PLASTIC in 1 CARTON (65852-012-04) / 113 mL in 1 BOTTLE, PLASTIC

Marketing

Marketing Status
Marketed Since 2018-10-02
Brand giltuss cough and cold
Generic dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride
Sample Package No

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["ORAL"], "spl_id": "3f12ee8f-d1c7-d73a-e063-6394a90a9199", "openfda": {"nui": ["N0000193956", "N0000008867", "N0000009560"], "unii": ["9D2RTI9KYH", "495W7451VQ", "04JA59TNSJ"], "rxcui": ["1251031"], "spl_set_id": ["3f12ee8f-d1c6-d73a-e063-6394a90a9199"], "pharm_class_pe": ["Decreased Respiratory Secretion Viscosity [PE]", "Increased Respiratory Secretions [PE]"], "pharm_class_epc": ["Expectorant [EPC]"], "manufacturer_name": ["Dextrum Laboratories Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, PLASTIC in 1 CARTON (65852-012-04)  / 113 mL in 1 BOTTLE, PLASTIC", "package_ndc": "65852-012-04", "marketing_start_date": "20181002"}], "brand_name": "Giltuss Cough and Cold", "product_id": "65852-012_3f12ee8f-d1c7-d73a-e063-6394a90a9199", "dosage_form": "SOLUTION", "pharm_class": ["Adrenergic alpha1-Agonists [MoA]", "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]", "alpha-1 Adrenergic Agonist [EPC]"], "product_ndc": "65852-012", "generic_name": "Dextromethorphan hydrobromide, Guaifenesin, Phenylephrine hydrochloride", "labeler_name": "Dextrum Laboratories Inc.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Giltuss Cough and Cold", "active_ingredients": [{"name": "DEXTROMETHORPHAN HYDROBROMIDE", "strength": "15 mg/5mL"}, {"name": "GUAIFENESIN", "strength": "300 mg/5mL"}, {"name": "PHENYLEPHRINE HYDROCHLORIDE", "strength": "10 mg/5mL"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20181002", "listing_expiration_date": "20261231"}