tylenol sinus severe

Generic: acetaminophen, guaifenesin, and phenylephrine hydrochloride

Labeler: kenvue brands llc
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name tylenol sinus severe
Generic Name acetaminophen, guaifenesin, and phenylephrine hydrochloride
Labeler kenvue brands llc
Dosage Form TABLET, COATED
Routes
ORAL
Active Ingredients

acetaminophen 325 mg/1, guaifenesin 200 mg/1, phenylephrine hydrochloride 5 mg/1

Manufacturer
Kenvue Brands LLC

Identifiers & Regulatory

Product NDC 50580-507
Product ID 50580-507_2172ef51-bd7d-a040-e063-6394a90aeac3
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2026-12-31
Marketing Start 2015-05-15

Pharmacologic Class

Established (EPC)
expectorant [epc]
Physiologic Effect
decreased respiratory secretion viscosity [pe] increased respiratory secretions [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 50580507
Hyphenated Format 50580-507

Supplemental Identifiers

RxCUI
1243679
UNII
362O9ITL9D 495W7451VQ 04JA59TNSJ
NUI
N0000193956 N0000008867 N0000009560

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name tylenol sinus severe (source: ndc)
Generic Name acetaminophen, guaifenesin, and phenylephrine hydrochloride (source: ndc)
Application Number M012 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 325 mg/1
  • 200 mg/1
  • 5 mg/1
source: ndc
Packaging
  • 2 BLISTER PACK in 1 CARTON (50580-507-01) / 12 TABLET, COATED in 1 BLISTER PACK
  • 3 CARTON in 1 PACKAGE (50580-507-02) / 2 BLISTER PACK in 1 CARTON / 12 TABLET, COATED in 1 BLISTER PACK
  • 2 TABLET, COATED in 1 POUCH (50580-507-03)
  • 50 POUCH in 1 CARTON (50580-507-04) / 2 TABLET, COATED in 1 POUCH
source: ndc

Packages (4)

50580-507-01 2 BLISTER PACK in 1 CARTON (50580-507-01) / 12 TABLET, COATED in 1 BLISTER PACK 50580-507-02 3 CARTON in 1 PACKAGE (50580-507-02) / 2 BLISTER PACK in 1 CARTON / 12 TABLET, COATED in 1 BLISTER PACK 50580-507-03 2 TABLET, COATED in 1 POUCH (50580-507-03) 50580-507-04 50 POUCH in 1 CARTON (50580-507-04) / 2 TABLET, COATED in 1 POUCH

Ingredients (3)

acetaminophen (325 mg/1) guaifenesin (200 mg/1) phenylephrine hydrochloride (5 mg/1)

Linked Drug Pages (1)

Tylenol Sinus Severe ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "2172ef51-bd7d-a040-e063-6394a90aeac3", "openfda": {"nui": ["N0000193956", "N0000008867", "N0000009560"], "unii": ["362O9ITL9D", "495W7451VQ", "04JA59TNSJ"], "rxcui": ["1243679"], "spl_set_id": ["7a60184f-91a9-4b85-b243-871deca63450"], "pharm_class_pe": ["Decreased Respiratory Secretion Viscosity [PE]", "Increased Respiratory Secretions [PE]"], "pharm_class_epc": ["Expectorant [EPC]"], "manufacturer_name": ["Kenvue Brands LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "2 BLISTER PACK in 1 CARTON (50580-507-01)  / 12 TABLET, COATED in 1 BLISTER PACK", "package_ndc": "50580-507-01", "marketing_start_date": "20150515"}, {"sample": false, "description": "3 CARTON in 1 PACKAGE (50580-507-02)  / 2 BLISTER PACK in 1 CARTON / 12 TABLET, COATED in 1 BLISTER PACK", "package_ndc": "50580-507-02", "marketing_start_date": "20200706"}, {"sample": false, "description": "2 TABLET, COATED in 1 POUCH (50580-507-03)", "package_ndc": "50580-507-03", "marketing_start_date": "20170717"}, {"sample": false, "description": "50 POUCH in 1 CARTON (50580-507-04)  / 2 TABLET, COATED in 1 POUCH", "package_ndc": "50580-507-04", "marketing_start_date": "20170717"}], "brand_name": "Tylenol Sinus Severe", "product_id": "50580-507_2172ef51-bd7d-a040-e063-6394a90aeac3", "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": "50580-507", "generic_name": "Acetaminophen, Guaifenesin, and Phenylephrine Hydrochloride", "labeler_name": "Kenvue Brands LLC", "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": "20150515", "listing_expiration_date": "20261231"}