Defensol-ito Solution
NDC Package 53145-333-15

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

Package Information

Defensol-ito (dextromethorphan, guiafenesin, phenylephrine) solution is classified as a

administered via oral route. This formulation utilizes a solution delivery system. Marketed by Menper Distributors, Inc, this product is identified by NDC 53145-333 and is authorized under FDA application M012.

Identification & Billing

NDC Package Code
53145-333-15
Package Description
1 BOTTLE, DROPPER in 1 CARTON / 30 mL in 1 BOTTLE, DROPPER
Product Code
53145-333
11-Digit Billing Format
53145033315
RxNorm Crosswalk
  • RxCUI: 1661314 - dextromethorphan HBr 4 MG / guaiFENesin 50 MG / phenylephrine HCl 2.5 MG in 1 mL Oral Solution
  • RxCUI: 1661314 - dextromethorphan hydrobromide 4 MG/ML / guaifenesin 50 MG/ML / phenylephrine hydrochloride 2.5 MG/ML Oral Solution

Clinical Specifications

Proprietary Name
Defensol-ito
Non-Proprietary Name
Dextromethorphan, Guiafenesin, Phenylephrine
Substance Name
Dextromethorphan Hydrobromide; Guaifenesin; Phenylephrine Hydrochloride
Dosage Form
Solution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
Pharmacologic Class

Regulatory & Marketing

Labeler Name
Menper Distributors, Inc
Product Type
Human Otc Drug
FDA Application #
M012
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
01-01-2014
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 53145-333-15 identifies a specific commercial package of 1 bottle, dropper in 1 carton / 30 ml in 1 bottle, dropper of Defensol-ito, a human over the counter drug labeled by Menper Distributors, Inc. This solution 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 Menper Distributors, Inc on January 01, 2014. The current certification is valid through December 31, 2026.

How is this Menper Distributors, Inc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 53145033315. 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)
53145-333-15
11-Digit CMS (5-4-2)
53145-0333-15

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