Tukol Cough And Cold Honey Flavor Syrup
NDC Package 50066-534-04

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

Package Information

Tukol Cough And Cold Honey Flavor (dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride) syrups is do not take more than 6 doses in any 24 hour periodthis adult strength product is not intended for use in children under 12 years of ageagedoseadults and children 12 years and over2 teaspoons (10 mL) every 4 hourschildren under 12do not use. This formulation utilizes a syrup delivery system. Marketed by Genomma Lab Usa, this product is identified by NDC 50066-534 and is authorized under FDA application M012.

Identification & Billing

NDC Package Code
50066-534-04
Package Description
1 BOTTLE, PLASTIC in 1 CARTON / 118 mL in 1 BOTTLE, PLASTIC
Product Code
50066-534
11-Digit Billing Format
50066053404
RxNorm Crosswalk
  • RxCUI: 1044949 - dextromethorphan HBr 20 MG / guaiFENesin 200 MG / phenylephrine HCl 10 MG in 10 mL Oral Solution
  • RxCUI: 1044949 - dextromethorphan hydrobromide 2 MG/ML / guaifenesin 20 MG/ML / phenylephrine hydrochloride 1 MG/ML Oral Solution
  • RxCUI: 1044949 - dextromethorphan HBr 10 MG / guaifenesin 100 MG / phenylephrine HCl 5 MG per 5 ML Oral Solution
  • RxCUI: 1044949 - dextromethorphan HBr 20 MG / guaifenesin 200 MG / phenylephrine HCl 10 MG per 10 ML Oral Solution

Clinical Specifications

Proprietary Name
Tukol Cough And Cold Honey Flavor
Non-Proprietary Name
Dextromethorphan Hydrobromide, Guaifenesin, And Phenylephrine Hydrochloride
Substance Name
Dextromethorphan Hydrobromide; Guaifenesin; Phenylephrine Hydrochloride
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
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
Pharmacologic Class
Usage Information
Do not take more than 6 doses in any 24 hour periodthis adult strength product is not intended for use in children under 12 years of ageagedoseadults and children 12 years and over2 teaspoons (10 mL) every 4 hourschildren under 12do not use

Regulatory & Marketing

Labeler Name
Genomma Lab Usa
Product Type
Human Otc Drug
FDA Application #
M012
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
09-20-2019
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 50066-534-04 identifies a specific commercial package of 1 bottle, plastic in 1 carton / 118 ml in 1 bottle, plastic of Tukol Cough And Cold Honey Flavor, a human over the counter drug labeled by Genomma Lab Usa. This syrup is formulated for oral use and contains 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 on September 20, 2019. The current certification is valid through December 31, 2026.

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

For medical billing and reimbursement, this package follows the 11-digit CMS format: 50066053404. 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)
50066-534-04
11-Digit CMS (5-4-2)
50066-0534-04

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