Sensodyne Pronamel Paste
NDC Package 0135-0484-04

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

Sensodyne Pronamel (potassium nitrate and sodium 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.•brush teeth thoroughly for at least 1 minute twice a day (morning and evening), and not more than 3 times a day, or as recommended by a dentist or doctor. This formulation utilizes a paste delivery system. Marketed by Haleon Us Holdings Llc, this product is identified by NDC 0135-0484 and is authorized under FDA application M022.

Identification & Billing

NDC Package Code
0135-0484-04
Package Description
1 TUBE in 1 CARTON / 184.3 g in 1 TUBE
Product Code
0135-0484
11-Digit Billing Format
00135048404
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
Sensodyne Pronamel Gentle Whitening
Non-Proprietary Name
Potassium Nitrate And Sodium Fluoride
Substance Name
Potassium Nitrate; Sodium Fluoride
Dosage Form
Paste - A semisolid3 dosage form, containing a large proportion (20 – 50%) of solids finely dispersed in a fatty vehicle. This dosage form is generally for external application to the skin or mucous membranes.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
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.•brush teeth thoroughly for at least 1 minute twice a day (morning and evening), and not more than 3 times a day, or as recommended by a dentist or doctor. Make sure to brush all sensitive areas of the teeth. Minimize swallowing. Spit out after brushing.•children under 12 years of age: consult a dentist or doctor.

Regulatory & Marketing

Labeler Name
Haleon Us Holdings Llc
Product Type
Human Otc Drug
FDA Application #
M022
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
10-18-2010
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 (0135-0484). Click a package code to view its specific billing and regulatory data.

0135-0484-01
1 TUBE in 1 CARTON / 113 g in 1 TUBE
0135-0484-02
1 TUBE in 1 CARTON / 76.5 g in 1 TUBE
0135-0484-03
22.6 g in 1 TUBE
0135-0484-05
2 TUBE in 1 CARTON / 113 g in 1 TUBE
0135-0484-06
4 TUBE in 1 CARTON / 184.3 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 0135-0484-04 identifies a specific commercial package of 1 tube in 1 carton / 184.3 g in 1 tube of Sensodyne Pronamel Gentle Whitening, a human over the counter drug labeled by Haleon Us Holdings Llc. This paste 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 Haleon Us Holdings Llc on October 18, 2010. The current certification is valid through December 31, 2026.

How is this Haleon Us Holdings Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00135048404. 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 (4-4-2)
0135-0484-04
11-Digit CMS (5-4-2)
00135-0484-04

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