Tusnel Pediatric Liquid
NDC Package 54859-604-16

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

Package Information

Tusnel Pediatric (dextromethorphan hbr, guaifenesin, phenylephrine hcl) liquids is usestemporary relieves cough due to minor throat and bronchial irritations as may occur with the common cold or inhaled irritantshelps loosen phlegm (mucus) and thin bronchial secretions to make cough more productive • temporarily relieves nasal congestion due to the common cold. This formulation utilizes a liquid delivery system. Marketed by Llorens Pharmaceutical International Division, Inc., this product is identified by NDC 54859-604 and is authorized under FDA application M012.

Identification & Billing

NDC Package Code
54859-604-16
Package Description
473 mL in 1 BOTTLE
Product Code
54859-604
11-Digit Billing Format
54859060416
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
Units Per Package
473 ML
RxNorm Crosswalk
  • RxCUI: 1119541 - dextromethorphan HBr 5 MG / guaiFENesin 75 MG / phenylephrine HCl 2.5 MG in 5 mL Oral Solution
  • RxCUI: 1119541 - dextromethorphan hydrobromide 1 MG/ML / guaifenesin 15 MG/ML / phenylephrine hydrochloride 0.5 MG/ML Oral Solution
  • RxCUI: 1119541 - dextromethorphan hydrobromide 5 MG / guaifenesin 75 MG / phenylephrine hydrochloride 2.5 MG per 5 ML Oral Solution

Clinical Specifications

Proprietary Name
Tusnel Pediatric DM
Non-Proprietary Name
Dextromethorphan Hbr, Guaifenesin, Phenylephrine Hcl
Substance Name
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
Usestemporary relieves cough due to minor throat and bronchial irritations as may occur with the common cold or inhaled irritantshelps loosen phlegm (mucus) and thin bronchial secretions to make cough more productive • temporarily relieves nasal congestion due to the common cold

Regulatory & Marketing

Labeler Name
Llorens Pharmaceutical International Division, Inc.
Product Type
Human Otc Drug
FDA Application #
M012
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
05-01-2019
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 54859-604-16 identifies a specific commercial package of 473 ml in 1 bottle of Tusnel Pediatric DM, a human over the counter drug labeled by Llorens Pharmaceutical International Division, 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 Llorens Pharmaceutical International Division, Inc. on May 01, 2019. The current certification is valid through December 31, 2026.

How is this Llorens Pharmaceutical International Division, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 54859060416. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. There are 473 total billable units per package. 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)
54859-604-16
11-Digit CMS (5-4-2)
54859-0604-16

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