Prevident 5000 Enamel Protect Gel, Dentifrice
NDC Package 0126-0022-92

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

Package Information

Prevident 5000 Enamel Protect (sodium fluoride and potassium nitrate) gel is a medication used to prevent cavities and to reduce pain from sensitive teeth (dentinal hypersensitivity). This formulation utilizes a gel, dentifrice delivery system. Marketed by Colgate Oral Pharmaceuticals, Inc., this product is identified by NDC 0126-0022.

Identification & Billing

NDC Package Code
0126-0022-92
Package Description
100 mL in 1 BOTTLE
Product Code
0126-0022
11-Digit Billing Format
00126002292
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
Units Per Package
100 ML

Clinical Specifications

Proprietary Name
Prevident 5000 Enamel Protect
Non-Proprietary Name
Sodium Fluoride And Potassium Nitrate
Substance Name
Potassium Nitrate; Sodium Fluoride
Dosage Form
Gel, Dentifrice - A combination of a dentifrice (formulation intended to clean and/or polish the teeth, and which may contain certain additional agents), and a gel. It is used with a toothbrush for the purpose of cleaning and polishing the teeth.
Administration Route
Dental - Administration to a tooth or teeth.
Active Ingredient(s)
Usage Information
This medication is used to prevent cavities and to reduce pain from sensitive teeth (dentinal hypersensitivity). Sodium fluoride works by making the teeth stronger and more resistant to decay caused by acid and bacteria. Potassium nitrate works by calming the nerves in the teeth. Do not use this medication in children younger than 6 years old unless directed by your doctor/dentist. Some products are not recommended for use in children younger than 12 years. Ask your doctor or dentist for more details about using this product safely in children. Caregivers/parents should watch the child to make sure the child does not swallow the medication while brushing.

Regulatory & Marketing

Labeler Name
Colgate Oral Pharmaceuticals, 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
03-30-2011
Listing Expiration
12-31-2027
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 0126-0022-92 identifies a specific commercial package of 100 ml in 1 bottle of Prevident 5000 Enamel Protect, a human prescription drug labeled by Colgate Oral Pharmaceuticals, Inc.. This product is billed per "ML" milliliter and contains an estimated amount of 100 billable units per package. This gel, dentifrice is formulated for dental use and contains potassium nitrate; 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 Colgate Oral Pharmaceuticals, Inc. on March 30, 2011. The current certification is valid through December 31, 2027.

What are the primary indications for this medication?

This medication is used to prevent cavities and to reduce pain from sensitive teeth (dentinal hypersensitivity). Sodium fluoride works by making the teeth stronger and more resistant to decay caused by acid and bacteria. Potassium nitrate works by calming the nerves in the teeth. Do not use this medication in children younger than 6 years old unless directed by your doctor/dentist. Some products are not recommended for use in children younger than 12 years. Ask your doctor or dentist for more details about using this product safely in children. Caregivers/parents should watch the child to make sure the child does not swallow the medication while brushing.

How is this Colgate Oral Pharmaceuticals, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00126002292. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. There are 100 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 (4-4-2)
0126-0022-92
11-Digit CMS (5-4-2)
00126-0022-92

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