Tylenol Cold Plus Flu Severe And Tylenol Cold Max Copack Kit
NDC Package 50580-231-01

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

Package Information

Tylenol Cold Plus Flu Severe And Tylenol Cold Max Copack (acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, guaifenesin, and phenylephrine hydrochloride) kits is do not take more than directed (see overdose warning)mL = milliliteruse only enclosed dosing cup designed for use with this product. This formulation utilizes a kit delivery system. Marketed by Kenvue Brands Llc, this product is identified by NDC 50580-231 and is authorized under FDA application M012.

Identification & Billing

NDC Package Code
50580-231-01
Package Description
1 KIT in 1 PACKAGE * 240 mL in 1 BOTTLE, PLASTIC (50580-403-08) * 240 mL in 1 BOTTLE, PLASTIC (50580-571-01)
Product Code
50580-231
11-Digit Billing Format
50580023101
RxNorm Crosswalk
  • RxCUI: 1369842 - acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG in 15 mL Oral Solution
  • RxCUI: 1369842 - acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 0.667 MG/ML / guaifenesin 13.3 MG/ML / phenylephrine hydrochloride 0.333 MG/ML Oral Solution
  • RxCUI: 1369842 - acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaifenesin 200 MG / phenylephrine HCl 5 MG per 15 ML Oral Solution
  • RxCUI: 1369842 - acetaminophen 650 MG / dextromethorphan HBr 20 MG / guaifenesin 400 MG / phenylephrine HCl 10 MG per 30 ML Oral Solution
  • RxCUI: 1369842 - APAP 21.7 MG/ML / Dextromethorphan Hydrobromide 0.667 MG/ML / Guaifenesin 13.3 MG/ML / Phenylephrine Hydrochloride 0.333 MG/ML Oral Solution

Clinical Specifications

Proprietary Name
Tylenol Cold Plus Flu Severe And Tylenol Cold Max Copack
Non-Proprietary Name
Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate, Guaifenesin, And Phenylephrine Hydrochloride
Dosage Form
Kit - A packaged collection of related material.
Usage Information
Do not take more than directed (see overdose warning)mL = milliliteruse only enclosed dosing cup designed for use with this product. Do not use any other dosing device.adults and children 12 years and overtake 30 mL in the dosing cup provided every 4 hours while symptoms lastdo not take more than 150 mL in 24 hours, unless directed by a doctorchildren under 12 yearsask a doctor do not take more than directed (see overdose warning)mL = milliliteruse only enclosed dosing cup designed for use with this product. Do not use any other dosing device.adults and children 12 years and overtake 30 mL in the dosing cup provided every 4 hours while symptoms lastdo not take more than 150 mL in 24 hours, unless directed by a doctorchildren under 12 yearsask a doctor

Regulatory & Marketing

Labeler Name
Kenvue Brands Llc
Product Type
Human Otc Drug
FDA Application #
M012
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
08-20-2018
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 50580-231-01 identifies a specific commercial package of 1 kit in 1 package * 240 ml in 1 bottle, plastic (50580-403-08) * 240 ml in 1 bottle, plastic (50580-571-01) of Tylenol Cold Plus Flu Severe And Tylenol Cold Max Copack, a human over the counter drug labeled by Kenvue Brands Llc. This kit is formulated for use and contains 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 August 20, 2018. 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: 50580023101. 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)
50580-231-01
11-Digit CMS (5-4-2)
50580-0231-01

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