Prevident Alcohol Free Mouthwash
NDC Package 0126-0033-16

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

Package Information

Prevident Alcohol Free (sodium fluoride) mouthwashes is a dental caries preventive, for weekly self-applied topical use. This formulation utilizes a mouthwash delivery system. Marketed by Colgate Oral Pharmaceuticals, Inc., this product is identified by NDC 0126-0033.

Identification & Billing

NDC Package Code
0126-0033-16
Package Description
473 mL in 1 BOTTLE, PLASTIC
Product Code
0126-0033
11-Digit Billing Format
00126003316

Clinical Specifications

Proprietary Name
Prevident Alcohol Free
Non-Proprietary Name
Sodium Fluoride
Substance Name
Sodium Fluoride
Dosage Form
Mouthwash - An aqueous solution which is most often used for its deodorant, refreshing, or antiseptic effect.
Administration Route
Dental - Administration to a tooth or teeth.
Active Ingredient(s)
SODIUM FLUORIDE .9 mg/mL
Usage Information
A dental caries preventive, for weekly self-applied topical use. Weekly rinsing with a neutral 0.2% sodium fluoride solution protects against dental caries in adults and pediatric patients. PreviDent® Rinse provides a ready-to-use preparation for convenient administration and favorable compliance. May be used in areas where drinking water is fluoridated since topical fluoride cannot produce fluorosis. (See WARNINGS for exception.)

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
06-13-2016
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 0126-0033-16 identifies a specific commercial package of 473 ml in 1 bottle, plastic of Prevident Alcohol Free, a human prescription drug labeled by Colgate Oral Pharmaceuticals, Inc.. This mouthwash is formulated for dental use and contains 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 June 13, 2016. The current certification is valid through December 31, 2027.

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: 00126003316. 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)
0126-0033-16
11-Digit CMS (5-4-2)
00126-0033-16

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