Viroxyn Professional Use
NDC Package 66774-1003-2

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

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Viroxyn Professional Use is using only warm water and a washcloth, clean the lip area of any lip preparations, lotions, ointments, residual beverages, or cosmetics, including lipstick.Remove the cardboard cap from the applicator end and place the cardboard cap on to the glass/plastic vial end, opposite the brush end of the product.Squeeze the cardboard cap to break open the inner glass vial.Saturate the applicator end with solution by holding the brush end down and squeezing the container until you can see liquid on the brush applicator.Touch the cold sore with the wet applicator and allow the numbing agent a few moments to numb your lip. Marketed by Quadex Pharmaceuticals Llc, this product is identified by NDC 66774-1003 and is authorized under FDA application part348.

Identification & Billing

NDC Package Code
66774-1003-2
Package Description
2 AMPULE in 1 BLISTER PACK / .6 mL in 1 AMPULE
Product Code
66774-1003
11-Digit Billing Format
66774100302
RxNorm Crosswalk
  • RxCUI: 1545787 - benzalkonium chloride 0.13 % / benzocaine 7.5 % Topical Solution
  • RxCUI: 1545787 - benzalkonium chloride 1.3 MG/ML / benzocaine 75 MG/ML Topical Solution
  • RxCUI: 1545789 - benzalkonium chloride 1.3 MG/ML / benzocaine 75 MG/ML Topical Solution [Viroxyn]
  • RxCUI: 1545789 - Viroxyn (benzalkonium chloride 0.13 % / benzocaine 7.5 % ) Topical Solution

Clinical Specifications

Proprietary Name
Viroxyn Professional Use
Dosage Form
-
Usage Information
Using only warm water and a washcloth, clean the lip area of any lip preparations, lotions, ointments, residual beverages, or cosmetics, including lipstick.Remove the cardboard cap from the applicator end and place the cardboard cap on to the glass/plastic vial end, opposite the brush end of the product.Squeeze the cardboard cap to break open the inner glass vial.Saturate the applicator end with solution by holding the brush end down and squeezing the container until you can see liquid on the brush applicator.Touch the cold sore with the wet applicator and allow the numbing agent a few moments to numb your lip. Then begin actual treatment.For best results, message the solution into the cold sore by rubbing. Rub firmly, but take care not to damage the tissue. The purpose of the rubbing is to deliver the drug to the infection site. Hold the vial so the solution flows to the sore.To treat most cold sores, usually one treatment is enough. If you symptoms go away and then return later, apply another dose for the second cold sore.Do not use more than 3 times a day.Children under 2 years of age – ask a doctor or dentist.Discard after use.

Regulatory & Marketing

Labeler Name
Quadex Pharmaceuticals Llc
FDA Application #
part348
Marketing Category
OTC MONOGRAPH NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final.
Start Marketing Date
10-22-2012
Listing Expiration
12-31-2017
Exclude Flag
I
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (66774-1003). Click a package code to view its specific billing and regulatory data.

66774-1003-3
3 AMPULE in 1 BLISTER PACK / .6 mL in 1 AMPULE
66774-1003-4
6 AMPULE in 1 BOX / .6 mL in 1 AMPULE
66774-1003-5
12 AMPULE in 1 BLISTER PACK / .6 mL in 1 AMPULE

* 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 66774-1003-2 identifies a specific commercial package of 2 ampule in 1 blister pack / .6 ml in 1 ampule of Viroxyn Professional Use, labeled by Quadex Pharmaceuticals Llc. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Quadex Pharmaceuticals Llc on October 22, 2012. The current certification is valid through December 31, 2017.

How is this Quadex Pharmaceuticals Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 66774100302. 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 (5-4-1)
66774-1003-2
11-Digit CMS (5-4-2)
66774-1003-02

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