childrens tylenol cold plus cough plus sore throat

Generic: acetaminophen 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 sore throat
Generic Name acetaminophen and dextromethorphan hydrobromide
Labeler kenvue brands llc
Dosage Form SUSPENSION
Routes
ORAL
Active Ingredients

acetaminophen 160 mg/5mL, dextromethorphan hydrobromide 5 mg/5mL

Manufacturer
Kenvue Brands LLC

Identifiers & Regulatory

Product NDC 50580-194
Product ID 50580-194_21d4a287-1f3b-ce36-e063-6294a90a1ef3
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
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 50580194
Hyphenated Format 50580-194

Supplemental Identifiers

RxCUI
1370113
UPC
0300450169044
UNII
362O9ITL9D 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 sore throat (source: ndc)
Generic Name acetaminophen and dextromethorphan hydrobromide (source: ndc)
Application Number M012 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 160 mg/5mL
  • 5 mg/5mL
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (50580-194-01) / 120 mL in 1 BOTTLE
source: ndc

Packages (1)

50580-194-01 1 BOTTLE in 1 CARTON (50580-194-01) / 120 mL in 1 BOTTLE

Ingredients (2)

acetaminophen (160 mg/5mL) dextromethorphan hydrobromide (5 mg/5mL)

Linked Drug Pages (1)

Childrens TYLENOL COLD PLUS COUGH PLUS SORE THROAT ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "21d4a287-1f3b-ce36-e063-6294a90a1ef3", "openfda": {"upc": ["0300450169044"], "unii": ["362O9ITL9D", "9D2RTI9KYH"], "rxcui": ["1370113"], "spl_set_id": ["e83f7911-22b4-4ffc-8f49-68f6acd2ebf5"], "manufacturer_name": ["Kenvue Brands LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (50580-194-01)  / 120 mL in 1 BOTTLE", "package_ndc": "50580-194-01", "marketing_start_date": "20170626"}], "brand_name": "Childrens TYLENOL COLD PLUS COUGH PLUS SORE THROAT", "product_id": "50580-194_21d4a287-1f3b-ce36-e063-6294a90a1ef3", "dosage_form": "SUSPENSION", "pharm_class": ["Sigma-1 Agonist [EPC]", "Sigma-1 Receptor Agonists [MoA]", "Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC]", "Uncompetitive NMDA Receptor Antagonists [MoA]"], "product_ndc": "50580-194", "generic_name": "Acetaminophen 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 SORE THROAT", "active_ingredients": [{"name": "ACETAMINOPHEN", "strength": "160 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"}