Ionite H Gel, Dentifrice
NDC Package 53045-271-04

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

Package Information

Ionite H (stannous fluoride) gel is • This is not a toothpaste. This formulation utilizes a gel, dentifrice delivery system. Marketed by Dharma Research, Inc., this product is identified by NDC 53045-271 and is authorized under FDA application M021.

Identification & Billing

NDC Package Code
53045-271-04
Package Description
122 g in 1 TUBE
Product Code
53045-271
11-Digit Billing Format
53045027104
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Ionite H
Non-Proprietary Name
Stannous Fluoride
Substance Name
Stannous 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)
STANNOUS FLUORIDE .4 mg/100g
Usage Information
• This is not a toothpaste. Read directions carefully before using.• Adults and children 6 years of age and older:  o Use once per day after brushing teeth thoroughly with toothpaste  o Twist off cap to remove foil seal  o Apply a small amount to a toothbrush and brush thoroughly on all tooth surfaces.  o Allow the gel to remain on your teeth for 1 minute  o Spit out. Do not swallow  o Do not eat, drink, or rinse for at least 30 minutes• Children under 6: consult a dentist or doctors

Regulatory & Marketing

Labeler Name
Dharma Research, Inc.
Product Type
Human Otc Drug
FDA Application #
M021
Marketing Category
OTC MONOGRAPH DRUG -
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 53045-271-04 identifies a specific commercial package of 122 g in 1 tube of Ionite H, a human over the counter drug labeled by Dharma Research, Inc.. This gel, dentifrice is formulated for dental 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 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: 53045027104. 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)
53045-271-04
11-Digit CMS (5-4-2)
53045-0271-04

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