Alpha-pro Gel
NDC Package 55346-0942-1

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

Package Information

Alpha-pro (sodium fluoride and hydrofluoric acid) gel is topical application of APF gel is indicated in the prevention of dental caries. This formulation utilizes a gel delivery system. Marketed by Dental Technologies, Inc., this product is identified by NDC 55346-0942.

Identification & Billing

NDC Package Code
55346-0942-1
Package Description
497 g in 1 BOTTLE
Product Code
55346-0942
11-Digit Billing Format
55346094201
RxNorm Crosswalk
  • RxCUI: 1297381 - hydrofluoric acid 1 % / phosphoric acid 1.12 % / sodium fluoride 1.8 % Oral Gel
  • RxCUI: 1297381 - hydrofluoric acid 0.01 MG/MG / phosphoric acid 0.0112 MG/MG / sodium fluoride 0.018 MG/MG Oral Gel

Clinical Specifications

Proprietary Name
Alpha-pro
Non-Proprietary Name
Sodium Fluoride And Hydrofluoric Acid
Substance Name
Hydrofluoric Acid; Sodium Fluoride
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
Dental - Administration to a tooth or teeth.
Active Ingredient(s)
Usage Information
Topical application of APF gel is indicated in the prevention of dental caries. This treatment is normally used two times per year and should not exceed four times a year.

Regulatory & Marketing

Labeler Name
Dental Technologies, Inc.
Product Type
Human Prescription Drug
Marketing Category
UNAPPROVED DRUG OTHER - An unapproved drug product in a marketing category that is not reflected on a particular list.
Start Marketing Date
04-01-2013
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 55346-0942-1 identifies a specific commercial package of 497 g in 1 bottle of Alpha-pro, a human prescription drug labeled by Dental Technologies, Inc.. This gel is formulated for dental use and contains hydrofluoric acid; sodium fluoride 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 Dental Technologies, Inc. on April 01, 2013. The current certification is valid through December 31, 2026.

How is this Dental Technologies, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 55346094201. 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)
55346-0942-1
11-Digit CMS (5-4-2)
55346-0942-01

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