Fluoride Paste
NDC Package 68599-9573-2

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

Fluoride (sodium fluoride) pastes is a medication used to prevent cavities. This formulation utilizes a paste delivery system. Marketed by Mckesson, this product is identified by NDC 68599-9573 and is authorized under FDA application M021.

Identification & Billing

NDC Package Code
68599-9573-2
Package Description
42.5 g in 1 TUBE
Product Code
68599-9573
11-Digit Billing Format
68599957302
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Fluoride
Non-Proprietary Name
Sodium Fluoride
Substance Name
Sodium Fluoride
Dosage Form
Paste - A semisolid3 dosage form, containing a large proportion (20 – 50%) of solids finely dispersed in a fatty vehicle. This dosage form is generally for external application to the skin or mucous membranes.
Administration Route
Dental - Administration to a tooth or teeth.
Active Ingredient(s)
SODIUM FLUORIDE .22 g/g
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
Mckesson
Product Type
Human Otc Drug
FDA Application #
M021
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
04-23-2026
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (68599-9573). Click a package code to view its specific billing and regulatory data.

68599-9573-1
24.1 g in 1 TUBE
68599-9573-3
78 g in 1 TUBE
68599-9573-4
113.4 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 68599-9573-2 identifies a specific commercial package of 42.5 g in 1 tube of Fluoride, a human over the counter drug labeled by Mckesson. This paste 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 Mckesson on April 23, 2026. The current certification is valid through December 31, 2027.

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 Mckesson product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 68599957302. 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)
68599-9573-2
11-Digit CMS (5-4-2)
68599-9573-02

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