Package 65852-011-04

Brand: giltuss childrens cough and cold

Generic: dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride
NDC Package

Package Facts

Identity

Package NDC 65852-011-04
Digits Only 6585201104
Product NDC 65852-011
Description

1 BOTTLE, PLASTIC in 1 CARTON (65852-011-04) / 118 mL in 1 BOTTLE, PLASTIC

Marketing

Marketing Status
Marketed Since 2018-11-07
Brand giltuss childrens 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": "3f025ef6-79e8-e833-e063-6294a90ab501", "openfda": {"nui": ["N0000193956", "N0000008867", "N0000009560"], "unii": ["9D2RTI9KYH", "495W7451VQ", "04JA59TNSJ"], "rxcui": ["1251031"], "spl_set_id": ["3f025ef6-79e7-e833-e063-6294a90ab501"], "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 (65852-011-04)  / 118 mL in 1 BOTTLE, PLASTIC", "package_ndc": "65852-011-04", "marketing_start_date": "20181107"}], "brand_name": "Giltuss Childrens Cough and Cold", "product_id": "65852-011_3f025ef6-79e8-e833-e063-6294a90ab501", "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": "65852-011", "generic_name": "Dextromethorphan hydrobromide, Guaifenesin, Phenylephrine hydrochloride", "labeler_name": "Dextrum Laboratories Inc.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Giltuss Childrens Cough and Cold", "active_ingredients": [{"name": "DEXTROMETHORPHAN HYDROBROMIDE", "strength": "7.5 mg/2.5mL"}, {"name": "GUAIFENESIN", "strength": "150 mg/2.5mL"}, {"name": "PHENYLEPHRINE HYDROCHLORIDE", "strength": "5 mg/2.5mL"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20181107", "listing_expiration_date": "20261231"}