childrens tylenol cold plus cough plus runny nose

Generic: acetaminophen, chlorpheniramine maleate, and dextromethorphan hydrobromide

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

Drug Facts

Product Profile

Brand Name childrens tylenol cold plus cough plus runny nose
Generic Name acetaminophen, chlorpheniramine maleate, and dextromethorphan hydrobromide
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

Manufacturer
Kenvue Brands LLC

Identifiers & Regulatory

Product NDC 50580-245
Product ID 50580-245_2e68d5d9-e9e2-7e7d-e063-6294a90aa3a1
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
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]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 50580245
Hyphenated Format 50580-245

Supplemental Identifiers

RxCUI
1086750
UPC
0300450161048
UNII
362O9ITL9D V1Q0O9OJ9Z 9D2RTI9KYH

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 cough plus runny nose (source: ndc)
Generic Name acetaminophen, chlorpheniramine maleate, and dextromethorphan hydrobromide (source: ndc)
Application Number M012 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 160 mg/5mL
  • 1 mg/5mL
  • 5 mg/5mL
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (50580-245-01) / 120 mL in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (50580-245-02) / 240 mL in 1 BOTTLE
  • 3 BOTTLE in 1 CARTON (50580-245-12) / 120 mL in 1 BOTTLE
source: ndc

Packages (3)

50580-245-01 1 BOTTLE in 1 CARTON (50580-245-01) / 120 mL in 1 BOTTLE 50580-245-02 1 BOTTLE in 1 CARTON (50580-245-02) / 240 mL in 1 BOTTLE 50580-245-12 3 BOTTLE in 1 CARTON (50580-245-12) / 120 mL in 1 BOTTLE

Ingredients (3)

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

Linked Drug Pages (1)

Childrens TYLENOL COLD plus COUGH plus RUNNY NOSE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "2e68d5d9-e9e2-7e7d-e063-6294a90aa3a1", "openfda": {"upc": ["0300450161048"], "unii": ["362O9ITL9D", "V1Q0O9OJ9Z", "9D2RTI9KYH"], "rxcui": ["1086750"], "spl_set_id": ["5b95905e-b729-4caf-921a-fc4ef815289c"], "manufacturer_name": ["Kenvue Brands LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (50580-245-01)  / 120 mL in 1 BOTTLE", "package_ndc": "50580-245-01", "marketing_start_date": "20170626"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (50580-245-02)  / 240 mL in 1 BOTTLE", "package_ndc": "50580-245-02", "marketing_start_date": "20240828"}, {"sample": false, "description": "3 BOTTLE in 1 CARTON (50580-245-12)  / 120 mL in 1 BOTTLE", "package_ndc": "50580-245-12", "marketing_start_date": "20240801"}], "brand_name": "Childrens TYLENOL COLD plus COUGH plus RUNNY NOSE", "product_id": "50580-245_2e68d5d9-e9e2-7e7d-e063-6294a90aa3a1", "dosage_form": "SUSPENSION", "pharm_class": ["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]"], "product_ndc": "50580-245", "generic_name": "Acetaminophen, Chlorpheniramine Maleate, and Dextromethorphan Hydrobromide", "labeler_name": "Kenvue Brands LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Childrens TYLENOL", "brand_name_suffix": "COLD plus COUGH plus RUNNY NOSE", "active_ingredients": [{"name": "ACETAMINOPHEN", "strength": "160 mg/5mL"}, {"name": "CHLORPHENIRAMINE MALEATE", "strength": "1 mg/5mL"}, {"name": "DEXTROMETHORPHAN HYDROBROMIDE", "strength": "5 mg/5mL"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20170626", "listing_expiration_date": "20261231"}