tylenol cold plus head congestion 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 cold plus head congestion severe
Generic Name acetaminophen, guaifenesin, and phenylephrine hydrochloride
Labeler kenvue brands llc
Dosage Form TABLET, FILM 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 50580-566
Product ID 50580-566_21aceda5-2c34-23df-e063-6394a90acb09
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2026-12-31
Marketing Start 2013-07-15

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 50580566
Hyphenated Format 50580-566

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 cold plus head congestion 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 (50580-566-25) / 12 TABLET, FILM COATED in 1 BLISTER PACK
source: ndc

Packages (1)

50580-566-25 2 BLISTER PACK in 1 CARTON (50580-566-25) / 12 TABLET, FILM COATED in 1 BLISTER PACK

Ingredients (3)

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

Linked Drug Pages (1)

Tylenol Cold Plus Head Congestion Severe ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "21aceda5-2c34-23df-e063-6394a90acb09", "openfda": {"nui": ["N0000193956", "N0000008867", "N0000009560"], "unii": ["362O9ITL9D", "495W7451VQ", "04JA59TNSJ"], "rxcui": ["1243679"], "spl_set_id": ["ce43e5c2-fe96-4462-882c-d7479318b33d"], "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 (50580-566-25)  / 12 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "50580-566-25", "marketing_start_date": "20130715"}], "brand_name": "Tylenol Cold Plus Head Congestion Severe", "product_id": "50580-566_21aceda5-2c34-23df-e063-6394a90acb09", "dosage_form": "TABLET, FILM 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": "50580-566", "generic_name": "Acetaminophen, Guaifenesin, and Phenylephrine Hydrochloride", "labeler_name": "Kenvue Brands LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Tylenol", "brand_name_suffix": "Cold Plus Head Congestion 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": "20130715", "listing_expiration_date": "20261231"}