Kolorz Neutral Fluoride Foam Aerosol, Foam
NDC Package 25047-765-44

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

Package Information

Kolorz Neutral Fluoride Foam (sodium fluoride) aerosols is for the topical application of fluoride in a neutral base to aid in the protection against dental caries. This formulation utilizes a aerosol, foam delivery system. Marketed by Dmg America, Llc, this product is identified by NDC 25047-765.

Identification & Billing

NDC Package Code
25047-765-44
Package Description
125 g in 1 CAN
Product Code
25047-765
11-Digit Billing Format
25047076544
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Kolorz Neutral Fluoride Foam Triple Mint
Non-Proprietary Name
Sodium Fluoride
Substance Name
Sodium Fluoride
Dosage Form
Aerosol, Foam - A dosage form containing one or more active ingredients, surfactants, aqueous or nonaqueous liquids, and the propellants; if the propellant is in the internal (discontinuous) phase (i.e., of the oil-in-water type), a stable foam is discharged, and if the propellant is in the external (continuous) phase (i.e., of the water-in-oil type), a spray or a quick-breaking foam is discharged.
Administration Route
Dental - Administration to a tooth or teeth.
Active Ingredient(s)
SODIUM FLUORIDE .9 mg/g
Usage Information
For the topical application of fluoride in a neutral base to aid in the protection against dental caries. Ideal for patients with extensive esthetic restorations and/or intolerance to acidic fluorides, Kolorz® Neutral Foam requires a 4-minute application.Shake can thoroughly for at least 30 seconds before each use. Hold can completely upside down to dispense. See package insert for dosage information.

Regulatory & Marketing

Labeler Name
Dmg America, Llc
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
11-22-2006
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 25047-765-44 identifies a specific commercial package of 125 g in 1 can of Kolorz Neutral Fluoride Foam Triple Mint, a human prescription drug labeled by Dmg America, Llc. This aerosol, foam 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 Dmg America, Llc on November 22, 2006. The current certification is valid through December 31, 2026.

How is this Dmg America, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 25047076544. 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)
25047-765-44
11-Digit CMS (5-4-2)
25047-0765-44

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