Supersmile Paste, Dentifrice
NDC Package 53567-0033-1

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

Package Information

Supersmile (sodium monofluorophosphate) pastes is place a pearl-sized drop of Whitening toothpaste on a dry toothbrush and brush in a circular motion for 2 minutes, 2x a day. This formulation utilizes a paste, dentifrice delivery system. Marketed by Robell Research, Inc, this product is identified by NDC 53567-0033 and is authorized under FDA application M021.

Identification & Billing

NDC Package Code
53567-0033-1
Package Description
40 g in 1 TUBE
Product Code
53567-0033
11-Digit Billing Format
53567003301
RxNorm Crosswalk
  • RxCUI: 2695772 - sodium monofluorophosphate 0.79 % Toothpaste
  • RxCUI: 2695772 - sodium monofluorophosphate 0.0079 MG/MG Toothpaste
  • RxCUI: 2695772 - sodium monofluorophosphate 0.79 % (fluoride ion 0.14 % )Toothpaste

Clinical Specifications

Proprietary Name
Supersmile Professional Whitening Tp Original Mint
Non-Proprietary Name
Sodium Monofluorophosphate
Substance Name
Sodium Monofluorophosphate
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)
SODIUM MONOFLUOROPHOSPHATE .14 g/100g
Usage Information
Place a pearl-sized drop of Whitening toothpaste on a dry toothbrush and brush in a circular motion for 2 minutes, 2x a day.

Regulatory & Marketing

Labeler Name
Robell Research, Inc
Product Type
Human Otc Drug
FDA Application #
M021
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
10-15-2024
Listing Expiration
12-31-2027
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 53567-0033-1 identifies a specific commercial package of 40 g in 1 tube of Supersmile Professional Whitening Tp Original Mint, a human over the counter drug labeled by Robell Research, Inc. This paste, dentifrice is formulated for dental use and contains sodium monofluorophosphate 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 Robell Research, Inc on October 15, 2024. The current certification is valid through December 31, 2027.

How is this Robell Research, Inc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 53567003301. 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 (5-4-1)
53567-0033-1
11-Digit CMS (5-4-2)
53567-0033-01

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