Hismile Grape Bubblegum Flavor Sodium Fluoride Anticavity Toothpast Gel
NDC Package 83013-331-06

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

Package Information

Hismile Grape Bubblegum Flavor Sodium Fluoride Anticavity Toothpast (sodium fluoride) gel is adults and children 2 years of age and older: Brush teeth thoroughly, preferably after each meal or at least twice a day, or use as directed by a dentist or doctor.Instruct children under 6 years of age in good brushing and rinsing habits ( to minimize swallowing).Supervise children as necessary until capable of using without supervision.Children under 2 years of age: Consult a dentist or doctor. This formulation utilizes a gel delivery system. Marketed by Hismile Pty Ltd, this product is identified by NDC 83013-331 and is authorized under FDA application M021.

Identification & Billing

NDC Package Code
83013-331-06
Package Description
60 g in 1 BOTTLE, PUMP
Product Code
83013-331
11-Digit Billing Format
83013033106
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Hismile Grape Bubblegum Flavor Sodium Fluoride Anticavity Toothpast
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 .243 g/100g
Usage Information
Adults and children 2 years of age and older: Brush teeth thoroughly, preferably after each meal or at least twice a day, or use as directed by a dentist or doctor.Instruct children under 6 years of age in good brushing and rinsing habits ( to minimize swallowing).Supervise children as necessary until capable of using without supervision.Children under 2 years of age: Consult a dentist or doctor.

Regulatory & Marketing

Labeler Name
Hismile Pty Ltd
Product Type
Human Otc Drug
FDA Application #
M021
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
01-09-2025
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 83013-331-06 identifies a specific commercial package of 60 g in 1 bottle, pump of Hismile Grape Bubblegum Flavor Sodium Fluoride Anticavity Toothpast, a human over the counter drug labeled by Hismile Pty Ltd. 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 Hismile Pty Ltd on January 09, 2025. The current certification is valid through December 31, 2026.

How is this Hismile Pty Ltd product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 83013033106. 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)
83013-331-06
11-Digit CMS (5-4-2)
83013-0331-06

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