Sensodyne Pronamel Liquid
NDC Package 0135-0451-01

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

Package Information

Sensodyne Pronamel (sodium fluoride) liquids is • adults and children 6 years of age and older:  • use once a day after brushing your teeth with a toothpaste. This formulation utilizes a liquid delivery system. Marketed by Haleon Us Holdings Llc, this product is identified by NDC 0135-0451 and is authorized under FDA application M022.

Identification & Billing

NDC Package Code
0135-0451-01
Package Description
500 mL in 1 BOTTLE
Product Code
0135-0451
11-Digit Billing Format
00135045101
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Sensodyne Pronamel Intensive Enamel Repair Extra Fresh
Non-Proprietary Name
Sodium Fluoride
Substance Name
Sodium Fluoride
Dosage Form
Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
SODIUM FLUORIDE .5 mg/mL
Usage Information
• adults and children 6 years of age and older:  • use once a day after brushing your teeth with a toothpaste.  • pour 10 milliliters into cap (10 mL mark on inside of cap); do not fill above the 10 mL mark.  • vigorously swish 10 milliliters of rinse between your teeth for 1 minute and then spit out.  • do not swallow the rinse.  • do not drink from the bottle.  • do not rinse mouth with water.  • do not eat or drink for 30 minutes after rinsing.  • instruct children under 12 years of age in good rinsing habits (to minimize swallowing).  • supervise children as necessary until capable of using without supervision.• children under 6 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
01-02-2024
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 0135-0451-01 identifies a specific commercial package of 500 ml in 1 bottle of Sensodyne Pronamel Intensive Enamel Repair Extra Fresh, a human over the counter drug labeled by Haleon Us Holdings Llc. This liquid is formulated for oral use and contains 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 January 02, 2024. 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: 00135045101. 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)
0135-0451-01
11-Digit CMS (5-4-2)
00135-0451-01

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