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  5. NDC Package Code: 50066-315-04 Tukol Childrens Cold And Flu

NDC Package 50066-315-04 Tukol Childrens Cold And Flu

Acetaminophen,Dextromethorphan Hydrobromide,Guaifenesin,And Phenylephrine Hydrochloride - 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:
50066-315-04
Package Description:
1 BOTTLE, PLASTIC in 1 CARTON / 118 mL in 1 BOTTLE, PLASTIC
Product Code:
50066-315
Proprietary Name:
Tukol Childrens Cold And Flu
Non-Proprietary Name:
Acetaminophen, Dextromethorphan Hydrobromide, Guaifenesin, And Phenylephrine Hydrochloride
Substance Name:
Acetaminophen; Dextromethorphan Hydrobromide; Guaifenesin; Phenylephrine Hydrochloride
Usage Information:
Do not give more than directed (see Overdose warning)product not labeled with directions or warnings for adult usedo not give more than 5 doses in any 24-hour perioddo not give more than 5 days unless directed by a doctormeasure only with dosing cup provideddose as follows or as directed by a doctormL=milliliter, tsp=teaspoonful as bulleted statement.AgeDoseChildren 6 to under 12 years of age10 mL or 2 tsp every 4 hoursChildren under 6 years of agedo not use
11-Digit NDC Billing Format:
50066031504
NDC to RxNorm Crosswalk:
  • RxCUI: 1116572 - acetaminophen 650 MG / dextromethorphan HBr 20 MG / guaiFENesin 400 MG / phenylephrine HCl 10 MG in 20 mL Oral Solution
  • RxCUI: 1116572 - acetaminophen 32.5 MG/ML / dextromethorphan hydrobromide 1 MG/ML / guaifenesin 20 MG/ML / phenylephrine hydrochloride 0.5 MG/ML Oral Solution
  • RxCUI: 1116572 - acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG per 10 ML Oral Solution
  • RxCUI: 1116572 - acetaminophen 650 MG / dextromethorphan HBr 20 MG / guaifenesin 400 MG / phenylephrine hydrochloride 10 MG per 20 ML Oral Solution
  • RxCUI: 1116572 - APAP 32.5 MG/ML / Dextromethorphan Hydrobromide 1 MG/ML / Guaifenesin 20 MG/ML / Phenylephrine Hydrochloride 0.5 MG/ML Oral Solution
    • Product Type:
    Human Otc Drug
    Labeler Name:
    Genomma Lab Usa
    Dosage Form:
    Syrup - An oral solution containing high concentrations of sucrose or other sugars; the term has also been used to include any other liquid dosage form prepared in a sweet and viscid vehicle, including oral suspensions.
    Administration Route(s):
  • Oral - Administration to or by way of the mouth.
    • Active Ingredient(s):
  • ACETAMINOPHEN 32.5 mg/mL
  • DEXTROMETHORPHAN HYDROBROMIDE 1 mg/mL
  • GUAIFENESIN 20 mg/mL
  • PHENYLEPHRINE HYDROCHLORIDE .5 mg/mL
    • Pharmacologic Class(es):
  • Adrenergic alpha1-Agonists - [MoA] (Mechanism of Action)
  • Decreased Respiratory Secretion Viscosity - [PE] (Physiologic Effect)
  • Expectorant - [EPC] (Established Pharmacologic Class)
  • Increased Respiratory Secretions - [PE] (Physiologic Effect)
  • 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:
    part341
    Marketing Category:
    OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph.
    Start Marketing Date:
    01-17-2023
    Listing Expiration Date:
    12-31-2024
    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 50066-315-04?

    The NDC Packaged Code 50066-315-04 is assigned to a package of 1 bottle, plastic in 1 carton / 118 ml in 1 bottle, plastic of Tukol Childrens Cold And Flu, a human over the counter drug labeled by Genomma Lab Usa. The product's dosage form is syrup and is administered via oral form.

    Is NDC 50066-315 included in the NDC Directory?

    Yes, Tukol Childrens Cold And Flu with product code 50066-315 is active and included in the NDC Directory. The product was first marketed by Genomma Lab Usa on January 17, 2023 and its listing in the NDC Directory is set to expire on December 31, 2024 if the product is not updated or renewed by the manufacturer.

    What is the 11-digit format for NDC 50066-315-04?

    The 11-digit format is 50066031504. 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
    5-3-250066-315-045-4-250066-0315-04