Campho-phenique Gel
NDC Package 69536-108-23

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

Package Information

Campho-phenique (camphor (synthetic) and phenol) gel is adults and children 2 years of age and over: clean the affected areaapply a small amount of this product to the cold sore or fever blister 1 to 3 times dailydo not bandagechildren under 2 years of age: ask a doctor. This formulation utilizes a gel delivery system. Marketed by Foundation Consumer Healthcare Llc, this product is identified by NDC 69536-108 and is authorized under FDA application M017.

Identification & Billing

NDC Package Code
69536-108-23
Package Description
1 TUBE in 1 CARTON / 6.5 g in 1 TUBE
Product Code
69536-108
11-Digit Billing Format
69536010823
Billing Unit
GM - Billing unit of "gram" is used when a product is measured by its weight.
Units Per Package
6.5 GM
RxNorm Crosswalk
  • RxCUI: 210347 - Campho-Phenique 10.8 % / 4.7 % Topical Gel
  • RxCUI: 210347 - camphor 0.108 MG/MG / phenol 0.047 MG/MG Topical Gel [Campho-Phenique]
  • RxCUI: 210347 - Campho-Phenique (camphor 10.8 % / phenol 4.7 % ) Topical Gel
  • RxCUI: 308939 - camphor 10.8 % / phenol 4.7 % Topical Gel
  • RxCUI: 308939 - camphor 0.108 MG/MG / phenol 0.047 MG/MG Topical Gel

Clinical Specifications

Proprietary Name
Campho-phenique Cold Sore Treatment
Non-Proprietary Name
Camphor (synthetic) And Phenol
Substance Name
Camphor (synthetic); 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
Adults and children 2 years of age and over: clean the affected areaapply a small amount of this product to the cold sore or fever blister 1 to 3 times dailydo not bandagechildren under 2 years of age: ask a doctor

Regulatory & Marketing

Labeler Name
Foundation Consumer Healthcare Llc
Product Type
Human Otc Drug
FDA Application #
M017
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
08-01-2017
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 69536-108-23 identifies a specific commercial package of 1 tube in 1 carton / 6.5 g in 1 tube of Campho-phenique Cold Sore Treatment, a human over the counter drug labeled by Foundation Consumer Healthcare Llc. This product is billed per "GM" gram and contains an estimated amount of 6.5 billable units per package. This gel is formulated for topical use and contains camphor (synthetic); 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 Foundation Consumer Healthcare Llc on August 01, 2017. The current certification is valid through December 31, 2026.

How is this Foundation Consumer Healthcare Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 69536010823. Quantities are measured in per "gm or gram", products billed per gram are products measured by weight.. There are 6.5 total billable units per package. 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)
69536-108-23
11-Digit CMS (5-4-2)
69536-0108-23

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