Package 53209-1003-2
Brand: tylenol cold plus flu severe
Generic: acetaminophen, dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloridePackage Facts
Identity
Package NDC
53209-1003-2
Digits Only
5320910032
Product NDC
53209-1003
Description
25 BLISTER PACK in 1 POUCH (53209-1003-2) / 2 TABLET, FILM COATED in 1 BLISTER PACK (53209-1003-1)
Marketing
Marketing Status
Brand
tylenol cold plus flu severe
Generic
acetaminophen, dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride
Sample Package
No
Linked Drug Pages (1)
Raw FDA Data
View complete raw FDA NDC JSON payload
{"route": ["ORAL"], "spl_id": "37e8b7f1-82e5-986b-e063-6394a90a07d7", "openfda": {"nui": ["N0000193956", "N0000008867", "N0000009560"], "unii": ["362O9ITL9D", "9D2RTI9KYH", "495W7451VQ", "04JA59TNSJ"], "rxcui": ["1110988"], "spl_set_id": ["be95332d-a2e0-42e8-bfb3-8850d74990ff"], "pharm_class_pe": ["Decreased Respiratory Secretion Viscosity [PE]", "Increased Respiratory Secretions [PE]"], "pharm_class_epc": ["Expectorant [EPC]"], "manufacturer_name": ["Morning Star OTC"]}, "finished": true, "packaging": [{"sample": false, "description": "25 BLISTER PACK in 1 POUCH (53209-1003-2) / 2 TABLET, FILM COATED in 1 BLISTER PACK (53209-1003-1)", "package_ndc": "53209-1003-2", "marketing_start_date": "20250619"}], "brand_name": "TYLENOL Cold Plus Flu Severe", "product_id": "53209-1003_37e8b7f1-82e5-986b-e063-6394a90a07d7", "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": "53209-1003", "generic_name": "Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, and Phenylephrine Hydrochloride", "labeler_name": "Morning Star OTC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "TYLENOL Cold Plus Flu", "brand_name_suffix": "Severe", "active_ingredients": [{"name": "ACETAMINOPHEN", "strength": "325 mg/1"}, {"name": "DEXTROMETHORPHAN HYDROBROMIDE", "strength": "10 mg/1"}, {"name": "GUAIFENESIN", "strength": "200 mg/1"}, {"name": "PHENYLEPHRINE HYDROCHLORIDE", "strength": "5 mg/1"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20250619", "listing_expiration_date": "20261231"}