NDC Package 83013-338-10 Grape Bubblegum Flavor Sodium Fluoride Anticavity Toothpast

Sodium Fluoride Gel Topical - View Billable Units, 11-Digit Format, RxNorm

Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:
83013-338-10
Package Description:
100 g in 1 TUBE
Product Code:
Proprietary Name:
Grape Bubblegum Flavor Sodium Fluoride Anticavity Toothpast
Non-Proprietary Name:
Sodium Fluoride
Substance Name:
Sodium Fluoride
11-Digit NDC Billing Format:
83013033810
Product Type:
Human Otc Drug
Labeler Name:
Hismile Pty Ltd
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(s):
Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.
Active Ingredient(s):
Sample Package:
No
FDA Application Number:
M021
Marketing Category:
OTC MONOGRAPH DRUG -
Start Marketing Date:
10-30-2025
Listing Expiration Date:
12-31-2026
Exclude Flag:
N

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.

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Frequently Asked Questions

What is NDC 83013-338-10?

The NDC Packaged Code 83013-338-10 is assigned to a package of 100 g in 1 tube of Grape Bubblegum Flavor Sodium Fluoride Anticavity Toothpast, a human over the counter drug labeled by Hismile Pty Ltd. The product's dosage form is gel and is administered via topical form.

Is NDC 83013-338 included in the NDC Directory?

Yes, Grape Bubblegum Flavor Sodium Fluoride Anticavity Toothpast with product code 83013-338 is active and included in the NDC Directory. The product was first marketed by Hismile Pty Ltd on October 30, 2025 and its listing in the NDC Directory is set to expire on December 31, 2026 if the product is not updated or renewed by the manufacturer.

What is the 11-digit format for NDC 83013-338-10?

The 11-digit format is 83013033810. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

This package code is originally configured in a 5-3-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
5-3-283013-338-105-4-283013-0338-10