Intensive Enamel Repair Whitening Tp Paste, Dentifrice
NDC Package 36800-362-00

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

Package Information

Intensive Enamel Repair Whitening Tp pastes is builds increasing protection against painful sensitivity of the teeth to cold, heat, acids, sweets or contactaids in the prevention of dental cavities. This formulation utilizes a paste, dentifrice delivery system. Marketed by Topco Associates Llc, this product is identified by NDC 36800-362 and is authorized under FDA application M021.

Identification & Billing

NDC Package Code
36800-362-00
Package Description
1 TUBE in 1 CARTON / 96.4 g in 1 TUBE
Product Code
36800-362
11-Digit Billing Format
36800036200
RxNorm Crosswalk
  • RxCUI: 1086243 - potassium nitrate 5 % / sodium fluoride 0.25 % Toothpaste
  • RxCUI: 1086243 - potassium nitrate 0.05 MG/MG / sodium fluoride 0.0025 MG/MG Toothpaste
  • RxCUI: 1086243 - K+ nitrate 0.05 MG/MG / Sodium Fluoride 0.0025 MG/MG Toothpaste
  • RxCUI: 1086243 - Pot nitrate 0.05 MG/MG / Sodium Fluoride 0.0025 MG/MG Toothpaste

Clinical Specifications

Proprietary Name
Intensive Enamel Repair Whitening Tp
Non-Proprietary Name
Intensive Enamel Repair Whitening Tp
Substance Name
Potassium Nitrate; Sodium 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
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
Usage Information
Builds increasing protection against painful sensitivity of the teeth to cold, heat, acids, sweets or contactaids in the prevention of dental cavities

Regulatory & Marketing

Labeler Name
Topco Associates Llc
Product Type
Human Otc Drug
FDA Application #
M021
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
06-17-2025
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (36800-362). Click a package code to view its specific billing and regulatory data.

36800-362-10
1 TUBE in 1 CARTON / 96.4 g in 1 TUBE

* 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 36800-362-00 identifies a specific commercial package of 1 tube in 1 carton / 96.4 g in 1 tube of Intensive Enamel Repair Whitening Tp, a human over the counter drug labeled by Topco Associates Llc. This paste, dentifrice is formulated for oral use and contains potassium nitrate; 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 Topco Associates Llc on June 17, 2025. The current certification is valid through December 31, 2026.

How is this Topco Associates Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 36800036200. 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)
36800-362-00
11-Digit CMS (5-4-2)
36800-0362-00

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