Ionite H Gel, Dentifrice
NDC Package 53045-280-04

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

Package Information

Ionite H (sodium fluoride, potassium nitrate) gel is this is a fluoride and potassium nitrate gel intended to aid in the prevention of dental decay and to help treat tooth sensitivity to cold, heat, sweets, acids, or contact. This formulation utilizes a gel, dentifrice delivery system. Marketed by Dharma Research, Inc., this product is identified by NDC 53045-280.

Identification & Billing

NDC Package Code
53045-280-04
Package Description
122 g in 1 TUBE
Product Code
53045-280
11-Digit Billing Format
53045028004
RxNorm Crosswalk
  • RxCUI: 637365 - potassium nitrate 5 % / sodium fluoride 1.1 % Toothpaste
  • RxCUI: 637365 - potassium nitrate 0.05 MG/MG / sodium fluoride 0.011 MG/MG Toothpaste
  • RxCUI: 637365 - K+ nitrate 0.05 MG/MG / Sodium Fluoride 0.011 MG/MG Toothpaste
  • RxCUI: 637365 - Pot nitrate 0.05 MG/MG / Sodium Fluoride 0.011 MG/MG Toothpaste
  • RxCUI: 637365 - potassium nitrate 5 % / sodium fluoride 1.1 % Gel Toothpaste

Clinical Specifications

Proprietary Name
Ionite H
Non-Proprietary Name
Sodium Fluoride, Potassium Nitrate
Substance Name
Potassium Nitrate; 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)
Usage Information
This is a fluoride and potassium nitrate gel intended to aid in the prevention of dental decay and to help treat tooth sensitivity to cold, heat, sweets, acids, or contact.

Regulatory & Marketing

Labeler Name
Dharma Research, 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
08-02-2015
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 53045-280-04 identifies a specific commercial package of 122 g in 1 tube of Ionite H, a human prescription drug labeled by Dharma Research, Inc.. This gel, dentifrice is formulated for dental use and contains potassium nitrate; 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 Dharma Research, Inc. on August 02, 2015. The current certification is valid through December 31, 2026.

How is this Dharma Research, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 53045028004. 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)
53045-280-04
11-Digit CMS (5-4-2)
53045-0280-04

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