Package 53809-201-01

{"route": ["ORAL"], "spl_id": "02354652-4696-45cc-94d0-d82092b0de8b", "openfda": {"nui": ["N0000193956", "N0000008867", "N0000009560"], "unii": ["9D2RTI9KYH", "495W7451VQ"], "rxcui": ["1147924"], "spl_set_id": ["7c4e7eca-0dc2-4b49-bda5-d61770ef9aca"], "pharm_class_pe": ["Decreased Respiratory Secretion Viscosity [PE]", "Increased Respiratory Secretions [PE]"], "pharm_class_epc": ["Expectorant [EPC]"], "manufacturer_name": ["Domel Laboratories"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 mL in 1 BOTTLE (53809-201-01)", "package_ndc": "53809-201-01", "marketing_start_date": "20160121"}, {"sample": false, "description": "118 mL in 1 BOTTLE (53809-201-04)", "package_ndc": "53809-201-04", "marketing_start_date": "20160121"}], "brand_name": "DOMETUSS-DM", "product_id": "53809-201_02354652-4696-45cc-94d0-d82092b0de8b", "dosage_form": "LIQUID", "pharm_class": ["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]"], "product_ndc": "53809-201", "generic_name": "GUAIFENESIN, DEXTROMETHORPHAN HBr", "labeler_name": "Domel Laboratories", "product_type": "HUMAN OTC DRUG", "brand_name_base": "DOMETUSS-DM", "active_ingredients": [{"name": "DEXTROMETHORPHAN HYDROBROMIDE", "strength": "30 mg/5mL"}, {"name": "GUAIFENESIN", "strength": "200 mg/5mL"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20160121", "listing_expiration_date": "20261231"}