Cold Sore Rescue Gel
NDC Package 43846-0031-2

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

Package Information

Cold Sore Rescue (borax, dulcamara, natrum muriaticum, ranunculus bulbosus, silicea) gel is apply at least 3 times daily over affected area.  For external use only.  Consult a physician for use in children under 12 years of age. This formulation utilizes a gel delivery system. Marketed by Peaceful Mountain, Inc., this product is identified by NDC 43846-0031.

Identification & Billing

NDC Package Code
43846-0031-2
Package Description
1 TUBE in 1 CARTON / 7 g in 1 TUBE (43846-0031-1)
Product Code
43846-0031
11-Digit Billing Format
43846003102

Clinical Specifications

Proprietary Name
Cold Sore Rescue
Non-Proprietary Name
Borax, Dulcamara, Natrum Muriaticum, Ranunculus Bulbosus, Silicea
Substance Name
Ranunculus Bulbosus Whole; Silicon Dioxide; Sodium Borate; Sodium Chloride; Solanum Dulcamara Top
Dosage Form
Gel - A semisolid3 dosage form that contains a gelling agent to provide stiffness to a solution or a colloidal dispersion.4 A gel may contain suspended particles.
Administration Route
Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.
Active Ingredient(s)
Usage Information
Apply at least 3 times daily over affected area.  For external use only.  Consult a physician for use in children under 12 years of age.

Regulatory & Marketing

Labeler Name
Peaceful Mountain, Inc.
Product Type
Human Otc Drug
Marketing Category
UNAPPROVED HOMEOPATHIC - A category specifying that a product is marketed as unapproved homeopathic product.
Start Marketing Date
12-08-2014
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 43846-0031-2 identifies a specific commercial package of 1 tube in 1 carton / 7 g in 1 tube (43846-0031-1) of Cold Sore Rescue, a human over the counter drug labeled by Peaceful Mountain, Inc.. This gel is formulated for topical use and contains ranunculus bulbosus whole; silicon dioxide; sodium borate; sodium chloride; solanum dulcamara top 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 Peaceful Mountain, Inc. on December 08, 2014. The current certification is valid through December 31, 2026.

How is this Peaceful Mountain, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 43846003102. 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)
43846-0031-2
11-Digit CMS (5-4-2)
43846-0031-02

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