childrens tylenol cold plus flu

Generic: acetaminophen, chlorpheniramine maleate, dextromethorphan hydrobromide, and phenylephrine hydrochloride

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

Drug Facts

Product Profile

Brand Name childrens tylenol cold plus flu
Generic Name acetaminophen, chlorpheniramine maleate, dextromethorphan hydrobromide, and phenylephrine hydrochloride
Labeler kenvue brands llc
Dosage Form SUSPENSION
Routes
ORAL
Active Ingredients

acetaminophen 160 mg/5mL, chlorpheniramine maleate 1 mg/5mL, dextromethorphan hydrobromide 5 mg/5mL, phenylephrine hydrochloride 2.5 mg/5mL

Manufacturer
Kenvue Brands LLC

Identifiers & Regulatory

Product NDC 50580-299
Product ID 50580-299_21e6aa92-576f-0f36-e063-6394a90a0c69
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2026-12-31
Marketing Start 2017-06-26

Pharmacologic Class

Classes
adrenergic alpha1-agonists [moa] histamine h1 receptor antagonists [moa] histamine-1 receptor antagonist [epc] 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]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 50580299
Hyphenated Format 50580-299

Supplemental Identifiers

RxCUI
1113397
UPC
0300450391056
UNII
362O9ITL9D V1Q0O9OJ9Z 9D2RTI9KYH 04JA59TNSJ

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 childrens tylenol cold plus flu (source: ndc)
Generic Name acetaminophen, chlorpheniramine maleate, dextromethorphan hydrobromide, and phenylephrine hydrochloride (source: ndc)
Application Number M012 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 160 mg/5mL
  • 1 mg/5mL
  • 5 mg/5mL
  • 2.5 mg/5mL
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (50580-299-01) / 120 mL in 1 BOTTLE
source: ndc

Packages (1)

50580-299-01 1 BOTTLE in 1 CARTON (50580-299-01) / 120 mL in 1 BOTTLE

Ingredients (4)

acetaminophen (160 mg/5mL) chlorpheniramine maleate (1 mg/5mL) dextromethorphan hydrobromide (5 mg/5mL) phenylephrine hydrochloride (2.5 mg/5mL)

Linked Drug Pages (1)

Childrens TYLENOL COLD Plus FLU ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "21e6aa92-576f-0f36-e063-6394a90a0c69", "openfda": {"upc": ["0300450391056"], "unii": ["362O9ITL9D", "V1Q0O9OJ9Z", "9D2RTI9KYH", "04JA59TNSJ"], "rxcui": ["1113397"], "spl_set_id": ["8b516736-86ac-47cb-a0ec-038d4c3a0020"], "manufacturer_name": ["Kenvue Brands LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (50580-299-01)  / 120 mL in 1 BOTTLE", "package_ndc": "50580-299-01", "marketing_start_date": "20170626"}], "brand_name": "Childrens TYLENOL COLD Plus FLU", "product_id": "50580-299_21e6aa92-576f-0f36-e063-6394a90a0c69", "dosage_form": "SUSPENSION", "pharm_class": ["Adrenergic alpha1-Agonists [MoA]", "Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]", "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": "50580-299", "generic_name": "Acetaminophen, Chlorpheniramine Maleate, Dextromethorphan Hydrobromide, and Phenylephrine Hydrochloride", "labeler_name": "Kenvue Brands LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Childrens TYLENOL", "brand_name_suffix": "COLD Plus FLU", "active_ingredients": [{"name": "ACETAMINOPHEN", "strength": "160 mg/5mL"}, {"name": "CHLORPHENIRAMINE MALEATE", "strength": "1 mg/5mL"}, {"name": "DEXTROMETHORPHAN HYDROBROMIDE", "strength": "5 mg/5mL"}, {"name": "PHENYLEPHRINE HYDROCHLORIDE", "strength": "2.5 mg/5mL"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20170626", "listing_expiration_date": "20261231"}