Package 50580-450-01
Brand: sudafed pe head congestion plus flu severe
Generic: acetaminophen, dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloridePackage 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
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"}