Childrens Tylenol Suspension
NDC Package 50580-299-01

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Childrens Tylenol (acetaminophen, chlorpheniramine maleate, dextromethorphan hydrobromide, and phenylephrine hydrochloride) suspension is this product does not contain directions or complete warnings for adult use.do not give more than directed (see overdose warning)shake well before usingmL = milliliterfind right dose on chart below. This formulation utilizes a suspension delivery system. Marketed by Kenvue Brands Llc, this product is identified by NDC 50580-299 and is authorized under FDA application M012.

Identification & Billing

NDC Package Code
50580-299-01
Package Description
1 BOTTLE in 1 CARTON / 120 mL in 1 BOTTLE
Product Code
50580-299
11-Digit Billing Format
50580029901
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk
  • RxCUI: 1113397 - acetaminophen 160 MG / chlorpheniramine maleate 1 MG / dextromethorphan HBr 5 MG / phenylephrine HCl 2.5 MG in 5 mL Oral Suspension
  • RxCUI: 1113397 - acetaminophen 32 MG/ML / chlorpheniramine maleate 0.2 MG/ML / dextromethorphan hydrobromide 1 MG/ML / phenylephrine hydrochloride 0.5 MG/ML Oral Suspension
  • RxCUI: 1113397 - acetaminophen 160 MG / chlorpheniramine maleate 1 MG / dextromethorphan HBr 5 MG / phenylephrine HCl 2.5 MG per 5 ML Oral Suspension
  • RxCUI: 1113397 - APAP 32 MG/ML / Chlorpheniramine Maleate 0.2 MG/ML / Dextromethorphan Hydrobromide 1 MG/ML / Phenylephrine Hydrochloride 0.5 MG/ML Oral Suspension

Clinical Specifications

Proprietary Name
Childrens Tylenol Cold Plus Flu
Non-Proprietary Name
Acetaminophen, Chlorpheniramine Maleate, Dextromethorphan Hydrobromide, And Phenylephrine Hydrochloride
Substance Name
Acetaminophen; Chlorpheniramine Maleate; Dextromethorphan Hydrobromide; Phenylephrine Hydrochloride
Dosage Form
Suspension - A liquid1 dosage form that contains solid particles dispersed in a liquid vehicle.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
Pharmacologic Class
Usage Information
This product does not contain directions or complete warnings for adult use.do 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)or as directed by a doctorunder 36under 4 yearsdo not use36-474 to 5 yearsdo not use unless directed by a doctor48-956 to 11 years10 mLAttention: use only enclosed dosing cup specifically designed for use with this product. Do not use any other dosing device.

Regulatory & Marketing

Labeler Name
Kenvue Brands Llc
Product Type
Human Otc Drug
FDA Application #
M012
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
06-26-2017
Listing Expiration
12-31-2026
Exclude Flag
N
Sample Package
No

Hierarchy Structure

Code Lineage

The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.

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

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 50580-299-01 identifies a specific commercial package of 1 bottle in 1 carton / 120 ml in 1 bottle of Childrens Tylenol Cold Plus Flu, a human over the counter drug labeled by Kenvue Brands Llc. This suspension is formulated for oral use and contains acetaminophen; chlorpheniramine maleate; dextromethorphan hydrobromide; phenylephrine hydrochloride as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Kenvue Brands Llc on June 26, 2017. The current certification is valid through December 31, 2026.

How is this Kenvue Brands Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 50580029901. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (5-3-2)
50580-299-01
11-Digit CMS (5-4-2)
50580-0299-01

Note: The zero is added to the Product segment to maintain the 5-4-2 structure.