Package 50580-450-01

Brand: sudafed pe head congestion plus flu severe

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

Package Facts

Identity

Package NDC 50580-450-01
Digits Only 5058045001
Product NDC 50580-450
Description

2 BLISTER PACK in 1 CARTON (50580-450-01) / 12 TABLET, FILM COATED in 1 BLISTER PACK

Marketing

Marketing Status
Marketed Since 2019-06-17
Brand sudafed pe head congestion plus flu severe
Generic acetaminophen, dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride
Sample Package No

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["ORAL"], "spl_id": "21c26e65-49b8-35f4-e063-6394a90a8e0b", "openfda": {"nui": ["N0000193956", "N0000008867", "N0000009560"], "unii": ["362O9ITL9D", "9D2RTI9KYH", "495W7451VQ", "04JA59TNSJ"], "rxcui": ["1098435"], "spl_set_id": ["1e528f78-0ced-4a06-935a-84056c921727"], "pharm_class_pe": ["Decreased Respiratory Secretion Viscosity [PE]", "Increased Respiratory Secretions [PE]"], "pharm_class_epc": ["Expectorant [EPC]"], "manufacturer_name": ["Kenvue Brands LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "2 BLISTER PACK in 1 CARTON (50580-450-01)  / 12 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "50580-450-01", "marketing_start_date": "20190617"}], "brand_name": "SUDAFED PE Head Congestion Plus Flu Severe", "product_id": "50580-450_21c26e65-49b8-35f4-e063-6394a90a8e0b", "dosage_form": "TABLET, FILM COATED", "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": "50580-450", "generic_name": "Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, and Phenylephrine Hydrochloride", "labeler_name": "Kenvue Brands LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "SUDAFED PE Head Congestion Plus Flu Severe", "active_ingredients": [{"name": "ACETAMINOPHEN", "strength": "325 mg/1"}, {"name": "DEXTROMETHORPHAN HYDROBROMIDE", "strength": "10 mg/1"}, {"name": "GUAIFENESIN", "strength": "100 mg/1"}, {"name": "PHENYLEPHRINE HYDROCHLORIDE", "strength": "5 mg/1"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20190617", "listing_expiration_date": "20261231"}