Package 27854-350-01

Brand: sedalmex xl flu

Generic: acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl
NDC Package

Package Facts

Identity

Package NDC 27854-350-01
Digits Only 2785435001
Product NDC 27854-350
Description

2 BLISTER PACK in 1 CARTON (27854-350-01) / 12 TABLET, FILM COATED in 1 BLISTER PACK

Marketing

Marketing Status
Marketed Since 2022-03-24
Brand sedalmex xl flu
Generic acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl
Sample Package No

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["ORAL"], "spl_id": "69c586ec-a04c-454f-9fd5-7f257b63125e", "openfda": {"nui": ["N0000193956", "N0000008867", "N0000009560"], "upc": ["0853030002755"], "unii": ["362O9ITL9D", "9D2RTI9KYH", "495W7451VQ", "04JA59TNSJ"], "rxcui": ["1098435"], "spl_set_id": ["f2edfedf-e06e-4d1b-8c2d-732e08ec113c"], "pharm_class_pe": ["Decreased Respiratory Secretion Viscosity [PE]", "Increased Respiratory Secretions [PE]"], "pharm_class_epc": ["Expectorant [EPC]"], "manufacturer_name": ["Belmora LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "2 BLISTER PACK in 1 CARTON (27854-350-01)  / 12 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "27854-350-01", "marketing_start_date": "20220324"}], "brand_name": "Sedalmex XL Flu", "product_id": "27854-350_69c586ec-a04c-454f-9fd5-7f257b63125e", "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": "27854-350", "generic_name": "Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl", "labeler_name": "Belmora LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Sedalmex XL Flu", "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": "20220324", "listing_expiration_date": "20261231"}