{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. 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"0363-8820-50", "0363-8820-10", "0363-8820-30" ], "unii": [ "3FYP5M0IJX", "AK7JF626KX", "1B5FPI42EN" ] } }, { "drugcharacterization": "2", "medicinalproduct": "TYLENOL", "activesubstance": { "activesubstancename": "ACETAMINOPHEN" }, "openfda": { "application_number": [ "M012", "M013" ], "brand_name": [ "TYLENOL COLD PLUS HEAD CONGESTION SEVERE", "TYLENOL REGULAR STRENGTH", "TYLENOL EXTRA STRENGTH" ], "generic_name": [ "ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE", "ACETAMINOPHEN" ], "manufacturer_name": [ "Kenvue Brands LLC" ], "product_ndc": [ "50580-566", "50580-495", "50580-458", "50580-496", "50580-475", "50580-451", "50580-590", "50580-692", "50580-488" ], "product_type": [ "HUMAN OTC DRUG" ], "route": [ "ORAL" ], "substance_name": [ "ACETAMINOPHEN", "GUAIFENESIN", "PHENYLEPHRINE HYDROCHLORIDE" ], "rxcui": [ "1243679", "209387", "313782", "198440", "209459" ], "spl_id": [ "21aceda5-2c34-23df-e063-6394a90acb09", "25b09044-067e-eb90-e063-6394a90a6d21", 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"50580-692-01", "50580-692-02", "50580-692-03", "50580-488-10", "50580-488-24", "50580-488-25", "50580-488-28", "50580-488-01", "50580-488-52", "50580-488-02", "50580-488-50", "50580-488-22" ], "nui": [ "N0000193956", "N0000008867", "N0000009560" ], "pharm_class_epc": [ "Expectorant [EPC]" ], "pharm_class_pe": [ "Decreased Respiratory Secretion Viscosity [PE]", "Increased Respiratory Secretions [PE]" ], "unii": [ "362O9ITL9D", "495W7451VQ", "04JA59TNSJ" ] } } ], "summary": { "narrativeincludeclinical": "CASE EVENT DATE: 20230823" } } } ] }