Childrens Tylenol Suspension
NDC 50580-194

View dosage, usage, ingredients, routes, and UNII mappings.
Table of Contents
  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 50580-194?
  5. Childrens Tylenol Cold Plus Cough Plus Sore Throat Uses
  6. Active Ingredients
  7. Active Ingredients UNII Codes
  8. Inactive Ingredients UNII Codes
  9. NDC to RxNorm Crosswalk
  10. Pharmacologic Classes
  11. Patient Education

Product Information

Childrens Tylenol (acetaminophen and dextromethorphan hydrobromide) is a OTC MONOGRAPH DRUG-approved product labeled by Kenvue Brands Llc. This medication is typically used as a sigma-1 agonist [epc]. It is supplied as a pink suspension for oral administration. This product entry covers the primary NDC 50580-194 and its associated package configuration. This profile includes active and inactive ingredient UNII references and FDA labeling data.

Primary Identification

NDC Product Code:
50580-194
Proprietary Name:
Childrens Tylenol Cold Plus Cough Plus Sore Throat
Non-Proprietary Name: [1]
Acetaminophen And Dextromethorphan Hydrobromide
Substance Name: [2]
Acetaminophen; Dextromethorphan Hydrobromide
NDC Directory Status:
Human Otc Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Code Navigator:

Clinical Specifications

Dosage Form:
Suspension - A liquid1 dosage form that contains solid particles dispersed in a liquid vehicle.
Administration Route(s): [4]
Oral - Administration to or by way of the mouth.

Labeler & Regulatory Data

Labeler Name: [5]
Kenvue Brands Llc
Labeler Code:
50580
Product Label ID:
e83f7911-22b4-4ffc-8f49-68f6acd2ebf5
FDA Application Number: [6]
M012
Marketing Category: [8]
OTC MONOGRAPH DRUG

Marketing Timeline

Start Marketing Date: [9]
06-26-2017
Listing Expiration Date: [11]
12-31-2026
Exclude Flag: [12]
N

Product Characteristics

Color(s):
PINK (C48328)
Flavor(s):

Code Structure Chart

Product Details

What is NDC 50580-194?

The NDC code 50580-194 is assigned by the FDA to the product Childrens Tylenol Cold Plus Cough Plus Sore Throat. It is commonly known by its generic name, acetaminophen and dextromethorphan hydrobromide. This pharmaceutical product is labeled by Kenvue Brands Llc and is currently categorized as listed product. The medication is a suspension administered via oral route. In terms of distribution, this product is available in a single package configuration. The associated package NDC(s) include: 50580-194-01. Beyond standard identification, this entry provides technical data including pharmacologic classes, UNII ingredient references, and RxNorm cross-referencing for healthcare systems.

What are the uses of this product?

This product does not contain directions or complete warnings for adult usedo not give more than directed (see overdose warning)shake well before usingmL = milliliterfind right dose on chart below. If possible, use weight to dose; otherwise, use age.remove the child protective cap and squeeze your child's dose into the dosing cuprepeat dose every 4 hours, while symptoms lastdo not give more than 5 times in 24 hoursWeight (lb)Age (yr)Dose (mL)under 36under 4 yearsdo not use36-474 to 5 years5 mL48-956 to 11 years10 mLAttention: use only enclosed dosing cup specifically designed for use with this product. Do not use any other dosing device.

What are Active Ingredients of this product?

An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
  • ACETAMINOPHEN 160 mg/5mL - Analgesic antipyretic derivative of acetanilide. It has weak anti-inflammatory properties and is used as a common analgesic, but may cause liver, blood cell, and kidney damage.
  • DEXTROMETHORPHAN HYDROBROMIDE 5 mg/5mL - Methyl analog of DEXTRORPHAN that shows high affinity binding to several regions of the brain, including the medullary cough center. This compound is an NMDA receptor antagonist (RECEPTORS, N-METHYL-D-ASPARTATE) and acts as a non-competitive channel blocker. It is one of the widely used ANTITUSSIVES, and is also used to study the involvement of glutamate receptors in neurotoxicity.

Which are the associated UNII Codes?

The UNII codes for the active ingredients in this product are:

Which are the Inactive Ingredients associated UNII Codes?

The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product. The UNII codes for the inactive ingredients in this product are:

What is the NDC to RxNorm Crosswalk for this product?

RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:
  • RxCUI: 1370113 - acetaminophen 160 MG / dextromethorphan HBr 5 MG in 5 mL Oral Suspension
  • RxCUI: 1370113 - acetaminophen 32 MG/ML / dextromethorphan hydrobromide 1 MG/ML Oral Suspension
  • RxCUI: 1370113 - acetaminophen 160 MG / dextromethorphan HBr 5 MG per 5 ML Oral Suspension
  • RxCUI: 1370113 - APAP 160 MG / dextromethorphan hydrobromide 5 MG per 5 ML Oral Suspension
  • RxCUI: 1370113 - APAP 32 MG/ML / Dextromethorphan Hydrobromide 1 MG/ML Oral Suspension

Which are the Pharmacologic Classes of this product?

A pharmacologic class is a group of drugs that share the same scientifically documented properties. The following is a list of the reported pharmacologic class(es) corresponding to the active ingredients of this product.

* Please review the full disclaimer at the bottom of this page.

Patient Education

Acetaminophen


Acetaminophen is used to relieve mild to moderate pain from headaches, muscle aches, menstrual periods, colds and sore throats, toothaches, backaches, and reactions to vaccinations (shots), and to reduce fever. Acetaminophen may also be used to relieve the pain of osteoarthritis (arthritis caused by the breakdown of the lining of the joints). Acetaminophen is in a class of medications called analgesics (pain relievers) and antipyretics (fever reducers). It works by changing the way the body senses pain and by cooling the body.
[Learn More]


Dextromethorphan


Dextromethorphan is used to temporarily relieve cough caused by the common cold, the flu, or other conditions. Dextromethorphan will relieve a cough but will not treat the cause of the cough or speed recovery. Dextromethorphan is in a class of medications called antitussives. It works by decreasing activity in the part of the brain that causes coughing.
[Learn More]


* Please review the full disclaimer at the bottom of this page.

Product & Regulatory Definitions
What is the Non-Proprietary Name? The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
What is the Substance Name? An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
What kind of product is this? Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.
What are the Administration Routes? The translation of the route code submitted by the firm, indicating route of administration.
What is the Labeler Name? Name of Company corresponding to the labeler code segment of the Product NDC.
What is the FDA Application Number? This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
What is the Marketing Category? Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
What is the Start Marketing Date? This is the date that the labeler indicates was the start of its marketing of the drug product.
What is the Listing Expiration Date? This is the date when the listing record will expire if not updated or certified by the product labeler.
What is the NDC Exclude Flag? This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions, or because the listing certification is expired, or because the listing data was inactivated by FDA, or because it was discontinued by the labeler. Possible values in this field are: "D", "E", "I", "N", "U".