Package 53209-1004-2

Brand: tylenol sinus severe

Generic: acetaminophen, guaifenesin, and phenylephrine hydrochloride
NDC Package

Package Facts

Identity

Package NDC 53209-1004-2
Digits Only 5320910042
Product NDC 53209-1004
Description

25 BLISTER PACK in 1 POUCH (53209-1004-2) / 2 TABLET, COATED in 1 BLISTER PACK (53209-1004-1)

Marketing

Marketing Status
Marketed Since 2025-06-19
Brand tylenol sinus severe
Generic acetaminophen, 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": "37e93f91-9e46-8346-e063-6294a90a3b76", "openfda": {"nui": ["N0000193956", "N0000008867", "N0000009560"], "unii": ["362O9ITL9D", "495W7451VQ", "04JA59TNSJ"], "rxcui": ["1243679"], "spl_set_id": ["37e939c6-064b-3548-e063-6294a90a337d"], "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 (53209-1004-2)  / 2 TABLET, COATED in 1 BLISTER PACK (53209-1004-1)", "package_ndc": "53209-1004-2", "marketing_start_date": "20250619"}], "brand_name": "Tylenol Sinus Severe", "product_id": "53209-1004_37e93f91-9e46-8346-e063-6294a90a3b76", "dosage_form": "TABLET, COATED", "pharm_class": ["Adrenergic alpha1-Agonists [MoA]", "Decreased Respiratory Secretion Viscosity [PE]", "Expectorant [EPC]", "Increased Respiratory Secretions [PE]", "alpha-1 Adrenergic Agonist [EPC]"], "product_ndc": "53209-1004", "generic_name": "Acetaminophen, Guaifenesin, and Phenylephrine Hydrochloride", "labeler_name": "Morning Star OTC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Tylenol Sinus Severe", "active_ingredients": [{"name": "ACETAMINOPHEN", "strength": "325 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"}