Sodium Fluoride Cream
NDC Package 65517-2000-2

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 approaching its end of marketing date. An upcoming end of marketing date means the product has been delisted but will remain in the NDC database until the end of marketing date is reached. In most cases, the FDA advises firms to use the expiration date of the last lot produced as the end marketing date, reflecting the possibility that the product may still be available even after manufacturing has stopped.

Sodium Fluoride (toothpaste) cream is a medication used to prevent cavities. This formulation utilizes a cream delivery system. Marketed by Dukal Llc, this product is identified by NDC 65517-2000 and is authorized under FDA application M022.

Identification & Billing

NDC Package Code
65517-2000-2
Package Description
42 g in 1 TUBE
Product Code
65517-2000
11-Digit Billing Format
65517200002
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Sodium Fluoride
Non-Proprietary Name
Toothpaste
Substance Name
Sodium Fluoride
Dosage Form
Cream - An emulsion, semisolid3 dosage form, usually containing > 20% water and volatiles5 and/or < 50% hydrocarbons, waxes, or polyols as the vehicle. This dosage form is generally for external application to the skin or mucous membranes.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
SODIUM FLUORIDE .22 g/100g
Usage Information
This medication is used to prevent cavities. It makes teeth stronger and more resistant to decay caused by acid and bacteria. Talk to your dentist or doctor about the benefits and risks of this product. This medication is not recommended for use in infants less than 6 months of age. This medication is not recommended for use in areas where the fluoride content in the water supply is greater than 0.6 parts per million. See Notes section for more information.

Regulatory & Marketing

Labeler Name
Dukal Llc
Product Type
Human Otc Drug
FDA Application #
M022
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
11-13-2013
End Marketing Date
07-31-2026
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (65517-2000). Click a package code to view its specific billing and regulatory data.

65517-2000-0
17 g in 1 TUBE
65517-2000-1
24 g in 1 TUBE
65517-2000-3
78 g in 1 TUBE
65517-2000-4
1 TUBE in 1 BOX / 42 g in 1 TUBE
65517-2000-5
1 TUBE in 1 BOX / 78 g in 1 TUBE
65517-2000-6
1 TUBE in 1 BOX / 135 g in 1 TUBE
65517-2000-7
1 TUBE in 1 BOX / 181 g in 1 TUBE

* 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 65517-2000-2 identifies a specific commercial package of 42 g in 1 tube of Sodium Fluoride, a human over the counter drug labeled by Dukal Llc. This cream is formulated for oral 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 Dukal Llc on November 13, 2013.

What are the primary indications for this medication?

This medication is used to prevent cavities. It makes teeth stronger and more resistant to decay caused by acid and bacteria. Talk to your dentist or doctor about the benefits and risks of this product. This medication is not recommended for use in infants less than 6 months of age. This medication is not recommended for use in areas where the fluoride content in the water supply is greater than 0.6 parts per million. See Notes section for more information.

How is this Dukal Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 65517200002. 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)
65517-2000-2
11-Digit CMS (5-4-2)
65517-2000-02

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