Tusnel Pediatric Drops Solution/ Drops
NDC Package 54859-605-01

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

Package Information

Tusnel Pediatric Drops (guaifenesin, phenylephrine hcl) solution/ dropses is UsesTemporarily relieves nasal congestion due to the common cold and thin bronchial secretions to make coughs more productiveHelps loosen phlegm (mucus) and thin bronchial secretions to make cough more productive.. This formulation utilizes a solution/ drops delivery system. Marketed by Llorens Pharmaceuticals International Division, this product is identified by NDC 54859-605 and is authorized under FDA application M012.

Identification & Billing

NDC Package Code
54859-605-01
Package Description
30 mL in 1 BOTTLE, DROPPER
Product Code
54859-605
11-Digit Billing Format
54859060501
RxNorm Crosswalk
  • RxCUI: 2268063 - guaiFENesin 25 MG / phenylephrine HCl 1.25 MG in 1 mL Oral Solution
  • RxCUI: 2268063 - guaifenesin 25 MG/ML / phenylephrine hydrochloride 1.25 MG/ML Oral Solution
  • RxCUI: 2268063 - guaifenesin 25 MG / phenylephrine hydrochloride 1.25 MG per 1 mL Oral Solution

Clinical Specifications

Proprietary Name
Tusnel Pediatric Drops
Non-Proprietary Name
Guaifenesin, Phenylephrine Hcl
Substance Name
Guaifenesin; Phenylephrine Hydrochloride
Dosage Form
Solution/ Drops - A solution which is usually administered in a drop-wise fashion.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
Pharmacologic Class
Usage Information
UsesTemporarily relieves nasal congestion due to the common cold and thin bronchial secretions to make coughs more productiveHelps loosen phlegm (mucus) and thin bronchial secretions to make cough more productive.

Regulatory & Marketing

Labeler Name
Llorens Pharmaceuticals International Division
Product Type
Human Otc Drug
FDA Application #
M012
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
08-01-2019
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 54859-605-01 identifies a specific commercial package of 30 ml in 1 bottle, dropper of Tusnel Pediatric Drops, a human over the counter drug labeled by Llorens Pharmaceuticals International Division. This solution/ drops is formulated for oral use and contains 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 Pharmaceuticals International Division on August 01, 2019. The current certification is valid through December 31, 2026.

How is this Llorens Pharmaceuticals International Division product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 54859060501. 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)
54859-605-01
11-Digit CMS (5-4-2)
54859-0605-01

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