Package 53345-021-01

Brand: daytime severe cold and flu

Generic: acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride
NDC Package

Package Facts

Identity

Package NDC 53345-021-01
Digits Only 5334502101
Product NDC 53345-021
Description

1 BAG in 1 BOX (53345-021-01) / 3000 CAPSULE, LIQUID FILLED in 1 BAG

Marketing

Marketing Status
Marketed Since 2014-07-11
Brand daytime severe cold and flu
Generic acetaminophen, 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": "27c7750e-5d1b-f49a-e063-6394a90a06ae", "openfda": {"nui": ["N0000193956", "N0000008867", "N0000009560"], "unii": ["362O9ITL9D", "9D2RTI9KYH", "495W7451VQ", "04JA59TNSJ"], "rxcui": ["1656815"], "spl_set_id": ["cbd3a905-1c41-4cb0-8df6-36784430d627"], "pharm_class_pe": ["Decreased Respiratory Secretion Viscosity [PE]", "Increased Respiratory Secretions [PE]"], "pharm_class_epc": ["Expectorant [EPC]"], "manufacturer_name": ["Humanwell PuraCap Pharmaceutical (Wuhan), Ltd."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BAG in 1 BOX (53345-021-01)  / 3000 CAPSULE, LIQUID FILLED in 1 BAG", "package_ndc": "53345-021-01", "marketing_start_date": "20140711"}], "brand_name": "Daytime Severe Cold and Flu", "product_id": "53345-021_27c7750e-5d1b-f49a-e063-6394a90a06ae", "dosage_form": "CAPSULE, LIQUID FILLED", "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": "53345-021", "generic_name": "acetaminophen, dextromethorphan hydrobromide, Guaifenesin, phenylephrine hydrochloride", "labeler_name": "Humanwell PuraCap Pharmaceutical (Wuhan), Ltd.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Daytime Severe Cold and Flu", "active_ingredients": [{"name": "ACETAMINOPHEN", "strength": "325 mg/1"}, {"name": "DEXTROMETHORPHAN HYDROBROMIDE", "strength": "10 mg/1"}, {"name": "GUAIFENESIN", "strength": "200 mg/1"}, {"name": "PHENYLEPHRINE HYDROCHLORIDE", "strength": "5 mg/1"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20140711", "listing_expiration_date": "20261231"}