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

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 inactivated by the FDA.

Tukol Childrens Cold And Flu is 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. Marketed by Genomma Lab Usa, this product is identified by NDC 50066-315 and is authorized under FDA application part341.

Identification & Billing

NDC Package Code
50066-315-04
Package Description
1 BOTTLE, PLASTIC in 1 CARTON / 118 mL in 1 BOTTLE, PLASTIC
Product Code
50066-315
11-Digit Billing Format
50066031504
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

Clinical Specifications

Proprietary Name
Tukol Childrens Cold And Flu
Dosage Form
-
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

Regulatory & Marketing

Labeler Name
Genomma Lab Usa
FDA Application #
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
12-31-2024
Exclude Flag
I
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 50066-315-04 identifies a specific commercial package of 1 bottle, plastic in 1 carton / 118 ml in 1 bottle, plastic of Tukol Childrens Cold And Flu, labeled by Genomma Lab Usa. 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 Genomma Lab Usa on January 17, 2023. The current certification is valid through December 31, 2024.

How is this Genomma Lab Usa product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 50066031504. 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)
50066-315-04
11-Digit CMS (5-4-2)
50066-0315-04

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