Topco Associates Llc Paste, Dentifrice
NDC Package 36800-481-49

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

Package Information

Topco Associates Llc (fluoride) pastes is adults and children 12 years of age and older: Apply at least a 1-inch strip of product onto a soft bristle toothbrush. This formulation utilizes a paste, dentifrice delivery system. Marketed by Topco Associates Llc, this product is identified by NDC 36800-481 and is authorized under FDA application M022.

Identification & Billing

NDC Package Code
36800-481-49
Package Description
1 TUBE in 1 CARTON / 113 g in 1 TUBE (36800-481-42)
Product Code
36800-481
11-Digit Billing Format
36800048149
RxNorm Crosswalk
  • RxCUI: 1038929 - potassium nitrate 5 % / sodium fluoride 0.24 % Toothpaste
  • RxCUI: 1038929 - potassium nitrate 0.05 MG/MG / sodium fluoride 0.0024 MG/MG Toothpaste
  • RxCUI: 1038929 - K+ nitrate 0.05 MG/MG / Sodium Fluoride 0.0024 MG/MG Toothpaste
  • RxCUI: 1038929 - Pot nitrate 0.05 MG/MG / Sodium Fluoride 0.0024 MG/MG Toothpaste
  • RxCUI: 1038929 - potassium nitrate 5 % / sodium fluoride 0.24 % (fluoride ion 0.14 % ) Toothpaste

Clinical Specifications

Proprietary Name
Topco Associates Llc Maximum Strength
Non-Proprietary Name
Fluoride
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
Dental - Administration to a tooth or teeth.
Active Ingredient(s)
Usage Information
Adults and children 12 years of age and older: Apply at least a 1-inch strip of product onto a soft bristle toothbrush. Brush teeth thoroughly for at least one minute, preferably after each meal or at least twice a day (morning and evening) or as recommended by a dentist or physican. Make sure to brush all sensitive areas of the teeth.

Regulatory & Marketing

Labeler Name
Topco Associates Llc
Product Type
Human Otc Drug
FDA Application #
M022
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
01-20-2011
End Marketing Date
06-26-2028
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 36800-481-49 identifies a specific commercial package of 1 tube in 1 carton / 113 g in 1 tube (36800-481-42) of Topco Associates Llc Maximum Strength, a human over the counter drug labeled by Topco Associates Llc. This paste, dentifrice is formulated for dental 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 January 20, 2011.

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

For medical billing and reimbursement, this package follows the 11-digit CMS format: 36800048149. 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)
36800-481-49
11-Digit CMS (5-4-2)
36800-0481-49

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