Hismile Gel, Dentifrice
NDC Package 83013-335-06

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

Package Information

Hismile (magically delicious flavor sodium fluoride anticavity toothpaste) gel is useAids in the prevention of dental cavities. This formulation utilizes a gel, dentifrice delivery system. Marketed by Hismile Pty Ltd, this product is identified by NDC 83013-335 and is authorized under FDA application M021.

Identification & Billing

NDC Package Code
83013-335-06
Package Description
60 g in 1 BOTTLE, PUMP
Product Code
83013-335
11-Digit Billing Format
83013033506
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Hismile
Non-Proprietary Name
Magically Delicious Flavor Sodium Fluoride Anticavity Toothpaste
Substance Name
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)
SODIUM FLUORIDE .243 g/100g
Usage Information
UseAids in the prevention of dental cavities

Regulatory & Marketing

Labeler Name
Hismile Pty Ltd
Product Type
Human Otc Drug
FDA Application #
M021
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
06-01-2025
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 83013-335-06 identifies a specific commercial package of 60 g in 1 bottle, pump of Hismile, a human over the counter drug labeled by Hismile Pty Ltd. This gel, dentifrice is formulated for dental 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 June 01, 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: 83013033506. 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)
83013-335-06
11-Digit CMS (5-4-2)
83013-0335-06

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