Cold Sore Treatment
NDC Package 49348-813-94

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

Package Information

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

Cold Sore Treatment is adults and children over 2 years of age:Clean the lip area of any lip preparations, lotions, ointments, residual beverages, or cosmetics including lipstick using warm water and a washclothRemove the cardboard top from applicator and place onto the glass/plastic vial end - opposite the brush end of the productSqueeze the cardboard to break the inner glass vial openSaturate the applicator end with solution by holding the brush end down and squeezing the container until you can see liquid on the brush applicatorFor best results, massage the solution into the cold sore by rubbing. Marketed by Mckesson, this product is identified by NDC 49348-813 and is authorized under FDA application part333A.

Identification & Billing

NDC Package Code
49348-813-94
Package Description
2 VIAL, PATENT DELIVERY SYSTEM in 1 PACKAGE / .6 mL in 1 VIAL, PATENT DELIVERY SYSTEM
Product Code
49348-813
11-Digit Billing Format
49348081394
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Cold Sore Treatment
Dosage Form
-
Usage Information
Adults and children over 2 years of age:Clean the lip area of any lip preparations, lotions, ointments, residual beverages, or cosmetics including lipstick using warm water and a washclothRemove the cardboard top from applicator and place onto the glass/plastic vial end - opposite the brush end of the productSqueeze the cardboard to break the inner glass vial openSaturate the applicator end with solution by holding the brush end down and squeezing the container until you can see liquid on the brush applicatorFor best results, massage 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 your symptoms go away and then return later, apply another dose. Do not use more than 3 times per dayDiscard after use.Children under 2 years of age: ask a doctor.

Regulatory & Marketing

Labeler Name
Mckesson
FDA Application #
part333A
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
11-28-2006
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 49348-813-94 identifies a specific commercial package of 2 vial, patent delivery system in 1 package / .6 ml in 1 vial, patent delivery system of Cold Sore Treatment, labeled by Mckesson. 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 Mckesson on November 28, 2006. The current certification is valid through December 31, 2017.

How is this Mckesson product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 49348081394. 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)
49348-813-94
11-Digit CMS (5-4-2)
49348-0813-94

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