Tukol Max Action Cold, Sore Throat And Cough Liquid
NDC Package 50066-516-25

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

Package Information

Tukol Max Action Cold, Sore Throat And Cough (acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl) liquids is do not take more than directedDo not take more than 6 doses in any 24 hoursThis adult strength product is not intended for use in children under 12 years of ageDose as follows or as directed by a doctorUse dose cup providedage                                                                        doseAdults and children12 years and older                                                 20 mL every 4 hoursChildren under 12 years of age                               Do not use. This formulation utilizes a liquid delivery system. Marketed by Genomma Lab Usa, Inc, this product is identified by NDC 50066-516 and is authorized under FDA application M012.

Identification & Billing

NDC Package Code
50066-516-25
Package Description
177 mL in 1 BOTTLE
Product Code
50066-516
11-Digit Billing Format
50066051625
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 Max Action Cold, Sore Throat And Cough
Non-Proprietary Name
Acetaminophen, Dextromethorphan Hbr, Guaifenesin, Phenylephrine Hcl
Substance Name
Acetaminophen; Dextromethorphan Hydrobromide; Guaifenesin; Phenylephrine Hydrochloride
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 directedDo not take more than 6 doses in any 24 hoursThis adult strength product is not intended for use in children under 12 years of ageDose as follows or as directed by a doctorUse dose cup providedage                                                                        doseAdults and children12 years and older                                                 20 mL every 4 hoursChildren under 12 years of age                               Do not use

Regulatory & Marketing

Labeler Name
Genomma Lab Usa, Inc
Product Type
Human Otc Drug
FDA Application #
M012
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
12-16-2016
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 50066-516-25 identifies a specific commercial package of 177 ml in 1 bottle of Tukol Max Action Cold, Sore Throat And Cough, a human over the counter drug labeled by Genomma Lab Usa, Inc. This liquid is formulated for oral use and contains acetaminophen; dextromethorphan hydrobromide; guaifenesin; phenylephrine hydrochloride 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 Genomma Lab Usa, Inc on December 16, 2016. The current certification is valid through December 31, 2026.

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

For medical billing and reimbursement, this package follows the 11-digit CMS format: 50066051625. 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)
50066-516-25
11-Digit CMS (5-4-2)
50066-0516-25

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