Extra Strength Tylenol Severe Cough Plus Sore Throat Night Liquid
NDC Package 50580-243-01

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

Package Information

Extra Strength Tylenol Severe Cough Plus Sore Throat Night (acetaminophen, dextromethorphan hydrobromide and doxylamine succinate.) liquids is do not take more than directed (see overdose warning) shake well before usingmL = milliliteruse only enclosed dosing cup designed for use with this product. This formulation utilizes a liquid delivery system. Marketed by Kenvue Brands Llc, this product is identified by NDC 50580-243 and is authorized under FDA application M012.

Identification & Billing

NDC Package Code
50580-243-01
Package Description
240 mL in 1 BOTTLE
Product Code
50580-243
11-Digit Billing Format
50580024301
RxNorm Crosswalk
  • RxCUI: 1042684 - acetaminophen 500 MG / dextromethorphan HBr 15 MG / doxylamine succinate 6.25 MG in 15 mL Oral Solution
  • RxCUI: 1042684 - acetaminophen 33.3 MG/ML / dextromethorphan hydrobromide 1 MG/ML / doxylamine succinate 0.417 MG/ML Oral Solution
  • RxCUI: 1042684 - acetaminophen 1000 MG / dextromethorphan hydrobromide 30 MG / doxylamine succinate 12.5 MG per 30 ML Oral Solution
  • RxCUI: 1042684 - acetaminophen 500 MG / dextromethorphan hydrobromide 15 MG / doxylamine succinate 6.25 MG per 15 ML Oral Solution
  • RxCUI: 1042684 - APAP 33.3 MG/ML / Dextromethorphan Hydrobromide 1 MG/ML / doxylamine succinate 0.417 MG/ML Oral Solution

Clinical Specifications

Proprietary Name
Extra Strength Tylenol Severe Cough Plus Sore Throat Night
Non-Proprietary Name
Acetaminophen, Dextromethorphan Hydrobromide And Doxylamine Succinate.
Substance Name
Acetaminophen; Dextromethorphan Hydrobromide; Doxylamine Succinate
Dosage Form
Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
Pharmacologic Class
Usage Information
Do not take more than directed (see overdose warning) shake well before usingmL = 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 6 hours while symptoms lastdo not take more than 90 mL in 24 hours, unless directed by a doctordo not use for more than 10 days 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
06-19-2023
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 50580-243-01 identifies a specific commercial package of 240 ml in 1 bottle of Extra Strength Tylenol Severe Cough Plus Sore Throat Night, a human over the counter drug labeled by Kenvue Brands Llc. This liquid is formulated for oral use and contains acetaminophen; dextromethorphan hydrobromide; doxylamine succinate 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 19, 2023. 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: 50580024301. 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)
50580-243-01
11-Digit CMS (5-4-2)
50580-0243-01

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