Fluorimax 5000 Paste, Dentifrice
NDC Package 57511-0504-2

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

Fluorimax 5000 (1.1% sodium fluoride toothpaste) pastes is a human prescription drug administered via topical route. This formulation utilizes a paste, dentifrice delivery system. Marketed by Elevate Oral Care, this product is identified by NDC 57511-0504.

Identification & Billing

NDC Package Code
57511-0504-2
Package Description
2 TUBE in 1 BOX / 96 g in 1 TUBE (57511-0504-1)
Product Code
57511-0504
11-Digit Billing Format
57511050402
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Fluorimax 5000
Non-Proprietary Name
1.1% Sodium Fluoride Toothpaste
Substance Name
Sodium Fluoride
Dosage Form
Paste, Dentifrice - A paste formulation intended to clean and/or polish the teeth, and which may contain certain additional agents.
Administration Route
  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.
  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.
Active Ingredient(s)

Regulatory & Marketing

Labeler Name
Elevate Oral Care
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
06-15-2022
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (57511-0504). Click a package code to view its specific billing and regulatory data.

57511-0504-1
96 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 57511-0504-2 identifies a specific commercial package of 2 tube in 1 box / 96 g in 1 tube (57511-0504-1) of Fluorimax 5000, a human prescription drug labeled by Elevate Oral Care. This paste, dentifrice is formulated for topical 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 Elevate Oral Care on June 15, 2022. The current certification is valid through December 31, 2026.

How is this Elevate Oral Care product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 57511050402. 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)
57511-0504-2
11-Digit CMS (5-4-2)
57511-0504-02

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