Tylenol Cold Max
NDC Package 50580-571-01

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

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.

Tylenol Cold Max is do not take more than directed (see overdose warning)mL = milliliteruse only enclosed dosing cup designed for use with this product. Marketed by Johnson & Johnson Consumer Inc., Mcneil Consumer Healthcare Division, this product is identified by NDC 50580-571 and is authorized under FDA application part341.

Identification & Billing

NDC Package Code
50580-571-01
Package Description
240 mL in 1 BOTTLE, PLASTIC
Product Code
50580-571
11-Digit Billing Format
50580057101
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
Units Per Package
240 ML
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 Max Night
Dosage Form
-
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
Johnson & Johnson Consumer Inc., Mcneil Consumer Healthcare Division
FDA Application #
part341
Marketing Category
OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph.
Start Marketing Date
04-13-2015
End Marketing Date
01-31-2021
Listing Expiration
01-31-2021
Exclude Flag
D
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 50580-571-01 identifies a specific commercial package of 240 ml in 1 bottle, plastic of Tylenol Cold Max Night, labeled by Johnson & Johnson Consumer Inc., Mcneil Consumer Healthcare Division. This product is billed per "ML" milliliter and contains an estimated amount of 240 billable units per package. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Johnson & Johnson Consumer Inc., Mcneil Consumer Healthcare Division on April 13, 2015. The current certification is valid through January 31, 2021.

How is this Johnson & Johnson Consumer Inc., Mcneil Consumer Healthcare Division product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 50580057101. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. There are 240 total billable units per package. 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)
50580-571-01
11-Digit CMS (5-4-2)
50580-0571-01

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