Package 53345-021-01
Brand: daytime severe cold and flu
Generic: acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloridePackage 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
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"}