Maximum Strength Cold Sore Treatment Gel
NDC Package 41250-411-01

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

Package Information

Maximum Strength Cold Sore Treatment (camphor, menthol, phenol, white petrolatum) gel is •Clean the affected area•Apply a small amount of this product to the affected area 1 to 3 times daily•Rub in gently•May be covered with a sterile bandage•Wash hands before and after applying cream•Do not share this product with anyone•Children under 12 years of age: ask a doctor. This formulation utilizes a gel delivery system. Marketed by Meijer Distribution Inc, this product is identified by NDC 41250-411 and is authorized under FDA application M022.

Identification & Billing

NDC Package Code
41250-411-01
Package Description
2 g in 1 TUBE
Product Code
41250-411
11-Digit Billing Format
41250041101
RxNorm Crosswalk
  • RxCUI: 2175793 - camphor 3 % / menthol 1 % / petrolatum 89.2 % / phenol 1.5 % Topical Gel
  • RxCUI: 2175793 - camphor 0.03 MG/MG / menthol 0.01 MG/MG / petrolatum 0.892 MG/MG / phenol 0.015 MG/MG Topical Gel

Clinical Specifications

Proprietary Name
Maximum Strength Cold Sore Treatment
Non-Proprietary Name
Camphor, Menthol, Phenol, White Petrolatum
Substance Name
Camphor (synthetic); Menthol, Unspecified Form; Petrolatum; Phenol
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
•Clean the affected area•Apply a small amount of this product to the affected area 1 to 3 times daily•Rub in gently•May be covered with a sterile bandage•Wash hands before and after applying cream•Do not share this product with anyone•Children under 12 years of age: ask a doctor

Regulatory & Marketing

Labeler Name
Meijer Distribution Inc
Product Type
Human Otc Drug
FDA Application #
M022
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
09-09-2019
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 41250-411-01 identifies a specific commercial package of 2 g in 1 tube of Maximum Strength Cold Sore Treatment, a human over the counter drug labeled by Meijer Distribution Inc. This gel is formulated for topical use and contains camphor (synthetic); menthol, unspecified form; petrolatum; phenol 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 Meijer Distribution Inc on September 09, 2019. The current certification is valid through December 31, 2026.

How is this Meijer Distribution Inc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 41250041101. 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)
41250-411-01
11-Digit CMS (5-4-2)
41250-0411-01

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