Package 65131-011-68

{"route": ["ORAL"], "spl_id": "ed1309d2-2a41-4fc7-86b5-5927a1f1c1d1", "openfda": {"nui": ["N0000193956", "N0000008867", "N0000009560"], "upc": ["0805418116875"], "unii": ["362O9ITL9D", "9D2RTI9KYH", "495W7451VQ", "04JA59TNSJ"], "rxcui": ["2712155"], "spl_set_id": ["1fb86dcb-6f51-4c29-99ad-a5a9b7b7526a"], "pharm_class_pe": ["Decreased Respiratory Secretion Viscosity [PE]", "Increased Respiratory Secretions [PE]"], "pharm_class_epc": ["Expectorant [EPC]"], "manufacturer_name": ["LABORATORIO MAGNACHEM INTERNATIONAL SRL"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, PLASTIC in 1 BOX (65131-011-68)  / 120 mL in 1 BOTTLE, PLASTIC", "package_ndc": "65131-011-68", "marketing_start_date": "20250421"}], "brand_name": "BRONCOCHEM EXPECTORANT II", "product_id": "65131-011_ed1309d2-2a41-4fc7-86b5-5927a1f1c1d1", "dosage_form": "SYRUP", "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": "65131-011", "generic_name": "ACETAMINOPHEN-CHLORPHENIRAMINE MALEATE-DEXTROMETHORPHAN HBr-GUAIFENESIN-PHENYLEPHRINE HCl", "labeler_name": "LABORATORIO MAGNACHEM INTERNATIONAL SRL", "product_type": "HUMAN OTC DRUG", "brand_name_base": "BRONCOCHEM", "brand_name_suffix": "EXPECTORANT II", "active_ingredients": [{"name": "ACETAMINOPHEN", "strength": "325 mg/10mL"}, {"name": "DEXTROMETHORPHAN HYDROBROMIDE", "strength": "20 mg/10mL"}, {"name": "GUAIFENESIN", "strength": "400 mg/10mL"}, {"name": "PHENYLEPHRINE HYDROCHLORIDE", "strength": "10 mg/10mL"}], "application_number": "M", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20250421", "listing_expiration_date": "20261231"}