Debacterol Canker Sore Pain Relief
NDC Package 62942-101-03

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.

Debacterol Canker Sore Pain Relief is debacterol is indicated in the topical treatment of ulcerating lesions of the oral cavity such as Recurrent Aphthous Stomatitis (Canker Sores). Marketed by Epien Medical Inc, this product is identified by NDC 62942-101.

Identification & Billing

NDC Package Code
62942-101-03
Package Description
1 VIAL, GLASS in 1 BOX / 1.5 mL in 1 VIAL, GLASS
Product Code
62942-101
11-Digit Billing Format
62942010103
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk
  • RxCUI: 1547711 - DEBACTEROL 50 % / 30 % Mucous Membrane Topical Solution
  • RxCUI: 1547711 - sulfonated phenol 500 MG/ML / sulfuric acid 300 MG/ML Mucous Membrane Topical Solution [Debacterol]
  • RxCUI: 1547711 - Debacterol 50 % / 30 % Mucous Membrane Topical Solution
  • RxCUI: 1547711 - sulfonated phenol 50 % / sulfuric acid 30 % Mucous Membrane Topical Solution [Debacterol]
  • RxCUI: 477215 - sulfonated phenol 50 % / sulfuric acid 30 % Mucous Membrane Topical Solution

Clinical Specifications

Proprietary Name
Debacterol Canker Sore Pain Relief
Dosage Form
-
Usage Information
Debacterol is indicated in the topical treatment of ulcerating lesions of the oral cavity such as Recurrent Aphthous Stomatitis (Canker Sores). Debacterol provides relief from the pain and discomfort of oral mucosal ulcers. Debacterol is not intended for the treatment of vesicular lesions, such as Cold Sores or Fever Blisters.

Regulatory & Marketing

Labeler Name
Epien Medical Inc
Marketing Category
UNAPPROVED DRUG OTHER - An unapproved drug product in a marketing category that is not reflected on a particular list.
Start Marketing Date
09-01-1996
Listing Expiration
12-31-2022
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 (62942-101). Click a package code to view its specific billing and regulatory data.

62942-101-12
12 APPLICATOR in 1 BOX / .2 mL in 1 APPLICATOR (62942-101-02)

* 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 62942-101-03 identifies a specific commercial package of 1 vial, glass in 1 box / 1.5 ml in 1 vial, glass of Debacterol Canker Sore Pain Relief, labeled by Epien Medical Inc. 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 Epien Medical Inc on September 01, 1996. The current certification is valid through December 31, 2022.

How is this Epien Medical Inc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 62942010103. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. 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)
62942-101-03
11-Digit CMS (5-4-2)
62942-0101-03

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