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  5. NDC Package Code: 50580-369-01 Tylenol Cold Plus Flu Plus Cough Night

NDC Package 50580-369-01 Tylenol Cold Plus Flu Plus Cough Night

Acetaminophen,Dextromethorphan Hydrobromide,Doxylamine Succinate,And Phenylephrine - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Frequently Asked Questions

Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:
50580-369-01
Package Description:
240 mL in 1 BOTTLE
Product Code:
50580-369
Proprietary Name:
Tylenol Cold Plus Flu Plus Cough Night
Non-Proprietary Name:
Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate, And Phenylephrine Hydrochloride
Substance Name:
Acetaminophen; Dextromethorphan Hydrobromide; Doxylamine Succinate; Phenylephrine Hydrochloride
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
11-Digit NDC Billing Format:
50580036901
Billing Unit:
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
NDC to RxNorm Crosswalk:
240 ML
NDC to 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
    • Product Type:
    Human Otc Drug
    Labeler Name:
    Johnson & Johnson Consumer Inc.
    Dosage Form:
    Solution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.
    Administration Route(s):
  • Oral - Administration to or by way of the mouth.
    • Active Ingredient(s):
  • ACETAMINOPHEN 325 mg/15mL
  • DEXTROMETHORPHAN HYDROBROMIDE 10 mg/15mL
  • DOXYLAMINE SUCCINATE 6.25 mg/15mL
  • PHENYLEPHRINE HYDROCHLORIDE 5 mg/15mL
    • Pharmacologic Class(es):
  • Adrenergic alpha1-Agonists - [MoA] (Mechanism of Action)
  • Antihistamine - [EPC] (Established Pharmacologic Class)
  • Histamine Receptor Antagonists - [MoA] (Mechanism of Action)
  • Sigma-1 Agonist - [EPC] (Established Pharmacologic Class)
  • Sigma-1 Receptor Agonists - [MoA] (Mechanism of Action)
  • Uncompetitive N-methyl-D-aspartate Receptor Antagonist - [EPC] (Established Pharmacologic Class)
  • Uncompetitive NMDA Receptor Antagonists - [MoA] (Mechanism of Action)
  • alpha-1 Adrenergic Agonist - [EPC] (Established Pharmacologic Class)
    • Sample Package:
    No
    FDA Application Number:
    M012
    Marketing Category:
    OTC MONOGRAPH DRUG -
    Start Marketing Date:
    06-17-2019
    Listing Expiration Date:
    12-31-2025
    Exclude Flag:
    N
    Code Structure:

    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 disclaimer below.

    Frequently Asked Questions

    What is NDC 50580-369-01?

    The NDC Packaged Code 50580-369-01 is assigned to a package of 240 ml in 1 bottle of Tylenol Cold Plus Flu Plus Cough Night, a human over the counter drug labeled by Johnson & Johnson Consumer Inc.. The product's dosage form is solution and is administered via oral form.This product is billed per "ML" milliliter and contains an estimated amount of 240 billable units per package.

    Is NDC 50580-369 included in the NDC Directory?

    Yes, Tylenol Cold Plus Flu Plus Cough Night with product code 50580-369 is active and included in the NDC Directory. The product was first marketed by Johnson & Johnson Consumer Inc. on June 17, 2019 and its listing in the NDC Directory is set to expire on December 31, 2025 if the product is not updated or renewed by the manufacturer.

    What is the NDC billing unit for package 50580-369-01?

    The contents of this package are billed per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume. The calculated billable units for this package is 240.

    What is the 11-digit format for NDC 50580-369-01?

    The 11-digit format is 50580036901. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

    This package code is originally configured in a 5-3-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

    10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
    5-3-250580-369-015-4-250580-0369-01