Sodium Fluoride 1.1% Dental Gel Bubblegum Gel
NDC Package 71085-079-02

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% Dental Gel Bubblegum (sodium fluoride) gel is use twice a day (morning and evening) in place of regular toothpaste or as recommended by a dentist or a physician.Adults and Children 6 Years of Age and Older: Twist off cap and remove foil seal. This formulation utilizes a gel delivery system. Marketed by Ipg Pharmaceuticals, Inc., this product is identified by NDC 71085-079.

Identification & Billing

NDC Package Code
71085-079-02
Package Description
1 TUBE in 1 CARTON / 200 g in 1 TUBE
Product Code
71085-079
11-Digit Billing Format
71085007902
Billing Unit
GM - Billing unit of "gram" is used when a product is measured by its weight.
Units Per Package
200 GM
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Sodium Fluoride 1.1% Dental Gel Bubblegum
Non-Proprietary Name
Sodium Fluoride
Substance Name
Sodium Fluoride
Dosage Form
Gel - A semisolid3 dosage form that contains a gelling agent to provide stiffness to a solution or a colloidal dispersion.4 A gel may contain suspended particles.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
SODIUM FLUORIDE 1.1 g/100g
Usage Information
Use twice a day (morning and evening) in place of regular toothpaste or as recommended by a dentist or a physician.Adults and Children 6 Years of Age and Older: Twist off cap and remove foil seal. Apply at least a1-inch strip of gel onto a soft bristle toothbrush. Brush teeth thoroughly for at least 1 minute. Spit out and rinse mouth thoroughly. Make sure to brush all sensitive areas of the teeth. Dosage form and Strengths: Dental gel containing 1.1% sodium fluoride.

Regulatory & Marketing

Labeler Name
Ipg Pharmaceuticals, Inc.
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
07-01-2025
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 71085-079-02 identifies a specific commercial package of 1 tube in 1 carton / 200 g in 1 tube of Sodium Fluoride 1.1% Dental Gel Bubblegum, a human prescription drug labeled by Ipg Pharmaceuticals, Inc.. This product is billed per "GM" gram and contains an estimated amount of 200 billable units per package. This gel 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 Ipg Pharmaceuticals, Inc. on July 01, 2025. The current certification is valid through December 31, 2026.

How is this Ipg Pharmaceuticals, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 71085007902. Quantities are measured in per "gm or gram", products billed per gram are products measured by weight.. There are 200 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)
71085-079-02
11-Digit CMS (5-4-2)
71085-0079-02

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