Package 35916-0189-1

{"route": ["ORAL"], "spl_id": "490b40e4-c895-2eee-e063-6394a90a1a0a", "openfda": {"unii": ["362O9ITL9D", "9D2RTI9KYH", "V9BI9B5YI2"], "rxcui": ["1426334"], "spl_set_id": ["2f7f078e-de04-9d53-e063-6394a90a409f"], "manufacturer_name": ["SOFTGEL HEALTHCARE PRIVATE LIMITED"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1000 CAPSULE, LIQUID FILLED in 1 BAG (35916-0189-1)", "package_ndc": "35916-0189-1", "marketing_start_date": "20250404"}], "brand_name": "Acetaminophen, Dextromethorphan Hydrobromide and Doxylamine Succinate", "product_id": "35916-0189_490b40e4-c895-2eee-e063-6394a90a1a0a", "dosage_form": "CAPSULE, LIQUID FILLED", "pharm_class": ["Antihistamine [EPC]", "Histamine Receptor Antagonists [MoA]", "Sigma-1 Agonist [EPC]", "Sigma-1 Receptor Agonists [MoA]", "Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC]", "Uncompetitive NMDA Receptor Antagonists [MoA]"], "product_ndc": "35916-0189", "generic_name": "Acetaminophen, Dextromethorphan Hydrobromide and Doxylamine Succinate", "labeler_name": "SOFTGEL HEALTHCARE PRIVATE LIMITED", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Acetaminophen, Dextromethorphan Hydrobromide and Doxylamine Succinate", "active_ingredients": [{"name": "ACETAMINOPHEN", "strength": "325 mg/1"}, {"name": "DEXTROMETHORPHAN HYDROBROMIDE", "strength": "10 mg/1"}, {"name": "DOXYLAMINE SUCCINATE", "strength": "6.25 mg/1"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20250404", "listing_expiration_date": "20271231"}