tylenol cold plus mucus severe (50580-511)

Drug Facts

Product Profile

Brand Name tylenol cold plus mucus severe

Generic Name acetaminophen, dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride

Labeler kenvue brands llc

Dosage Form SOLUTION

Routes

ORAL

Active Ingredients

acetaminophen 325 mg/15mL, dextromethorphan hydrobromide 10 mg/15mL, guaifenesin 200 mg/15mL, phenylephrine hydrochloride 5 mg/15mL

Manufacturer

Kenvue Brands LLC

Identifiers & Regulatory

Product NDC 50580-511

Product ID 50580-511_22c7e800-a49a-73b9-e063-6394a90aebd9

Product Type HUMAN OTC DRUG

Marketing Category OTC MONOGRAPH DRUG

Application Number M012

Listing Expiration 2026-12-31

Marketing Start 2015-06-22

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 50580511

Hyphenated Format 50580-511

Supplemental Identifiers

RxCUI

1369842

UPC

0300450521088

UNII

362O9ITL9D 9D2RTI9KYH 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 cold plus mucus severe (source: ndc)

Generic Name acetaminophen, dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride (source: ndc)

Application Number M012 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

325 mg/15mL
10 mg/15mL
200 mg/15mL
5 mg/15mL

source: ndc

Packaging

240 mL in 1 BOTTLE, PLASTIC (50580-511-01)

source: ndc

Packages (1)

50580-511-01 240 mL in 1 BOTTLE, PLASTIC (50580-511-01)

Ingredients (4)

acetaminophen (325 mg/15mL) dextromethorphan hydrobromide (10 mg/15mL) guaifenesin (200 mg/15mL) phenylephrine hydrochloride (5 mg/15mL)

Linked Drug Pages (1)

TYLENOL Cold Plus Mucus Severe ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload

{"route": ["ORAL"], "spl_id": "22c7e800-a49a-73b9-e063-6394a90aebd9", "openfda": {"nui": ["N0000193956", "N0000008867", "N0000009560"], "upc": ["0300450521088"], "unii": ["362O9ITL9D", "9D2RTI9KYH", "495W7451VQ", "04JA59TNSJ"], "rxcui": ["1369842"], "spl_set_id": ["24ac94e8-b223-424e-bcd2-9c027c8ff9ed"], "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": "240 mL in 1 BOTTLE, PLASTIC (50580-511-01)", "package_ndc": "50580-511-01", "marketing_start_date": "20150622"}], "brand_name": "TYLENOL Cold Plus Mucus Severe", "product_id": "50580-511_22c7e800-a49a-73b9-e063-6394a90aebd9", "dosage_form": "SOLUTION", "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": "50580-511", "generic_name": "Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, and Phenylephrine hydrochloride", "labeler_name": "Kenvue Brands LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "TYLENOL Cold Plus Mucus Severe", "active_ingredients": [{"name": "ACETAMINOPHEN", "strength": "325 mg/15mL"}, {"name": "DEXTROMETHORPHAN HYDROBROMIDE", "strength": "10 mg/15mL"}, {"name": "GUAIFENESIN", "strength": "200 mg/15mL"}, {"name": "PHENYLEPHRINE HYDROCHLORIDE", "strength": "5 mg/15mL"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20150622", "listing_expiration_date": "20261231"}