Smilesense Paste, Dentifrice
NDC Package 72644-639-01

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

Package Information

Smilesense (stannous fluoride) pastes is adults and children 12 years of age and older: apply at least a 1-inch strip of the product onto a soft bristle toothbrush. This formulation utilizes a paste, dentifrice delivery system. Marketed by Sgii, Inc, this product is identified by NDC 72644-639 and is authorized under FDA application M021.

Identification & Billing

NDC Package Code
72644-639-01
Package Description
108 g in 1 TUBE
Product Code
72644-639
11-Digit Billing Format
72644063901
RxNorm Crosswalk
  • RxCUI: 416784 - stannous fluoride 0.454 % (fluoride ion 0.16 % ) Toothpaste
  • RxCUI: 416784 - stannous fluoride 0.00454 MG/MG Toothpaste
  • RxCUI: 416784 - stannous fluoride 0.454 % (fluoride ion 0.14 % ) Toothpaste
  • RxCUI: 416784 - stannous fluoride 0.454 % (fluoride ion 0.15 % ) Toothpaste

Clinical Specifications

Proprietary Name
Smilesense
Non-Proprietary Name
Stannous Fluoride
Substance Name
Stannous Fluoride
Dosage Form
Paste, Dentifrice - A paste formulation intended to clean and/or polish the teeth, and which may contain certain additional agents.
Administration Route
Dental - Administration to a tooth or teeth.
Active Ingredient(s)
STANNOUS FLUORIDE .11 g/100g
Usage Information
Adults and children 12 years of age and older: apply at least a 1-inch strip of the product onto a soft bristle toothbrush. In the AM & PM, for up to 2 minutes, gently brush your teeth using small, circular motions or as recommended by a dentist or doctor. Work your way slowly around your mouth, addressing every area of the teeth (outer, inside & chewing surface) including all sensitive areas. Open wide and angle your toothbrush toward the gum line. Rinse your mouth & toothbrush. With fresh toothpaste, brush the surface of your tongue, with reaching as far as comfortable into your mouth. Rinse again. Follow-up by flossing between all your teeth at least once a day. Do not swallowchildren under 12 yeasr: ask a dentist

Regulatory & Marketing

Labeler Name
Sgii, Inc
Product Type
Human Otc Drug
FDA Application #
M021
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
07-01-2024
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 72644-639-01 identifies a specific commercial package of 108 g in 1 tube of Smilesense, a human over the counter drug labeled by Sgii, Inc. This paste, 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 Sgii, Inc on July 01, 2024. The current certification is valid through December 31, 2026.

How is this Sgii, Inc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 72644063901. 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)
72644-639-01
11-Digit CMS (5-4-2)
72644-0639-01

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