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  5. NDC Package Code: 50580-299-01 Childrens Tylenol Cold Plus Flu

NDC Package 50580-299-01 Childrens Tylenol Cold Plus Flu

Acetaminophen,Chlorpheniramine Maleate,Dextromethorphan Hydrobromide,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:
50580-299-01
Package Description:
1 BOTTLE in 1 CARTON / 120 mL in 1 BOTTLE
Product Code:
50580-299
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
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.
11-Digit NDC Billing Format:
50580029901
Billing Unit:
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
NDC to 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
    • Product Type:
    Human Otc Drug
    Labeler Name:
    Johnson & Johnson Consumer Inc.
    Dosage Form:
    Suspension - A liquid1 dosage form that contains solid particles dispersed in a liquid vehicle.
    Administration Route(s):
  • Oral - Administration to or by way of the mouth.
    • Active Ingredient(s):
  • ACETAMINOPHEN 160 mg/5mL
  • CHLORPHENIRAMINE MALEATE 1 mg/5mL
  • DEXTROMETHORPHAN HYDROBROMIDE 5 mg/5mL
  • PHENYLEPHRINE HYDROCHLORIDE 2.5 mg/5mL
    • Pharmacologic Class(es):
  • Adrenergic alpha1-Agonists - [MoA] (Mechanism of Action)
  • Histamine H1 Receptor Antagonists - [MoA] (Mechanism of Action)
  • Histamine-1 Receptor Antagonist - [EPC] (Established Pharmacologic Class)
  • 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:
    06-26-2017
    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 50580-299-01?

    The NDC Packaged Code 50580-299-01 is assigned to a 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 Johnson & Johnson Consumer Inc.. The product's dosage form is suspension and is administered via oral form.

    Is NDC 50580-299 included in the NDC Directory?

    Yes, Childrens Tylenol Cold Plus Flu with product code 50580-299 is active and included in the NDC Directory. The product was first marketed by Johnson & Johnson Consumer Inc. on June 26, 2017 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 50580-299-01?

    The contents of this package are billed per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.

    What is the 11-digit format for NDC 50580-299-01?

    The 11-digit format is 50580029901. 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
    5-3-250580-299-015-4-250580-0299-01