Sodium Fluoride 1.1% Gel, Dentifrice
NDC Package 35573-435-56

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

Package Information

Sodium Fluoride 1.1% (sodium fluoride) gel is a dental caries preventive; for once daily self-applied topical use. This formulation utilizes a gel, dentifrice delivery system. Marketed by Burel Pharmaceuticals Llc, this product is identified by NDC 35573-435.

Identification & Billing

NDC Package Code
35573-435-56
Package Description
1 TUBE in 1 CARTON / 56 g in 1 TUBE
Product Code
35573-435
11-Digit Billing Format
35573043556
Billing Unit
GM - Billing unit of "gram" is used when a product is measured by its weight.
Units Per Package
56 GM
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Sodium Fluoride 1.1%
Non-Proprietary Name
Sodium Fluoride
Substance Name
Sodium Fluoride
Dosage Form
Gel, Dentifrice - A combination of a dentifrice (formulation intended to clean and/or polish the teeth, and which may contain certain additional agents), and a gel. It is used with a toothbrush for the purpose of cleaning and polishing the teeth.
Administration Route
Dental - Administration to a tooth or teeth.
Active Ingredient(s)
SODIUM FLUORIDE 5 mg/g
Usage Information
A dental caries preventive; for once daily self-applied topical use. It is well established that 1.1% sodium fluoride is safe and extraordinarily effective as a caries preventive when applied frequently with mouthpiece applicators.1-4 Sodium Fluoride 1.1% Dental Gel in a squeeze-tube is easily applied onto a toothbrush. This prescription dental gel should be used once daily following use of your regular toothpaste unless otherwise instructed by your dental professional. May be used whether or not drinking water is fluoridated, since topical fluoride cannot produce fluorosis. (See WARNINGS for exception.)

Regulatory & Marketing

Labeler Name
Burel Pharmaceuticals 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
02-28-2020
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 35573-435-56 identifies a specific commercial package of 1 tube in 1 carton / 56 g in 1 tube of Sodium Fluoride 1.1%, a human prescription drug labeled by Burel Pharmaceuticals Llc. This gel, dentifrice 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 Burel Pharmaceuticals Llc on February 28, 2020. The current certification is valid through December 31, 2026.

How is this Burel Pharmaceuticals Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 35573043556. Quantities are measured in per "gm or gram", products billed per gram are products measured by weight.. There are 56 total billable units per package. 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)
35573-435-56
11-Digit CMS (5-4-2)
35573-0435-56

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