Tukol A Liquid
NDC Package 50066-536-24
Package Information
Tukol A (dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride) liquids is age dosechildren 6 to 12 years 2 tsp (10 mL) every 4 hourschildren 4 to 6 years 1 tsp (5 mL) every 4 hourschildren under 4 years do not usedo not exceed 6 doses in a 24-hour perioduse enclosed dosage cuptsp = teaspoon, mL = milliliter. This formulation utilizes a liquid delivery system. Marketed by Genomma Lab Usa, Inc., this product is identified by NDC 50066-536 and is authorized under FDA application part341.
Identification & Billing
- RxCUI: 1370205 - dextromethorphan HBr 5 MG / guaiFENesin 50 MG / phenylephrine HCl 2.5 MG in 5 mL Oral Solution
- RxCUI: 1370205 - dextromethorphan hydrobromide 1 MG/ML / guaifenesin 10 MG/ML / phenylephrine hydrochloride 0.5 MG/ML Oral Solution
- RxCUI: 1370205 - dextromethorphan hydrobromide 10 MG / guaifenesin 100 MG / phenylephrine hydrochloride 5 MG per 10 ML Oral Solution
- RxCUI: 1370205 - dextromethorphan hydrobromide 5 MG / guaifenesin 50 MG / phenylephrine hydrochloride 2.5 MG per 5 ML Oral Solution
Clinical Specifications
- Adrenergic alpha1-Agonists - [MoA] (Mechanism of Action)
- 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)
Regulatory & Marketing
Hierarchy Structure
- 50066 - Genomma Lab Usa, Inc.
- 50066-536 - Tukol A
- 50066-536-24 - 118 mL in 1 BOTTLE
- 50066-536 - Tukol A
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.
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Frequently Asked Questions
What is the distribution configuration for this product package?
The code 50066-536-24 identifies a specific commercial package of 118 ml in 1 bottle of Tukol A, a human over the counter drug labeled by Genomma Lab Usa, Inc.. This liquid 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, Inc. on June 09, 2014. 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: 50066053624. 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:
Note: The zero is added to the Product segment to maintain the 5-4-2 structure.