Home Care Fluoride Gel
NDC Package 55346-0401-2

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

Home Care Fluoride (stannous fluoride) gel is adults and children 6 years of age and older: Use once a day after brushing your teeth with a toothpaste. This formulation utilizes a gel delivery system. Marketed by Dental Technologies, Inc., this product is identified by NDC 55346-0401 and is authorized under FDA application M021.

Identification & Billing

NDC Package Code
55346-0401-2
Package Description
121.9 g in 1 TUBE
Product Code
55346-0401
11-Digit Billing Format
55346040102

Clinical Specifications

Proprietary Name
Home Care Fluoride
Non-Proprietary Name
Stannous Fluoride
Substance Name
Stannous 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
  • Dental - Administration to a tooth or teeth.
  • Oral - Administration to or by way of the mouth.
Active Ingredient(s)
STANNOUS FLUORIDE .969 mg/g
Usage Information
Adults and children 6 years of age and older: Use once a day after brushing your teeth with a toothpaste. Apply the gel to your teeth and brush thoroughly. Allow the gel to remain on your teeth for 1 minute and then spit out. Do not swallow the gel. Do not eat or drink for 30 minutes after brushing.Instruct children under 12 years of age in the use of this product (to minimize swallowing). Supervise children as necessary until capable of using without supervision.Children under 6 years of age: Consult a dentist or doctor.

Regulatory & Marketing

Labeler Name
Dental Technologies, Inc.
Product Type
Human Otc Drug
FDA Application #
M021
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
12-31-1999
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 (55346-0401). Click a package code to view its specific billing and regulatory data.

55346-0401-1
121.9 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 55346-0401-2 identifies a specific commercial package of 121.9 g in 1 tube of Home Care Fluoride, a human over the counter drug labeled by Dental Technologies, Inc.. This gel is formulated for dental; oral use and contains stannous 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 Dental Technologies, Inc. on December 31, 1999. The current certification is valid through December 31, 2026.

How is this Dental Technologies, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 55346040102. 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)
55346-0401-2
11-Digit CMS (5-4-2)
55346-0401-02

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