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  5. NDC Package Code: 51206-311-02 Opal By Opalescence Sensitivity

NDC Package 51206-311-02 Opal By Opalescence Sensitivity

Potassium Nitrate And Sodium Fluoride Gel, Dentifrice Dental - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Frequently Asked Questions

Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:
51206-311-02
Package Description:
3 CARTON in 1 PACKAGE, COMBINATION / 1 TUBE in 1 CARTON (51206-311-01) / 133 g in 1 TUBE
Product Code:
51206-311
Proprietary Name:
Opal By Opalescence Sensitivity
Non-Proprietary Name:
Potassium Nitrate And Sodium Fluoride
Substance Name:
Potassium Nitrate; Sodium Fluoride
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) or as recommended by a dentist or doctor. Make sure to brush all sensitive areas of the teeth.Children under 12 years of age: Consult a dentist or doctor.
11-Digit NDC Billing Format:
51206031102
NDC to 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
    • Product Type:
    Human Otc Drug
    Labeler Name:
    Ultradent Products, Inc.
    Dosage Form:
    Gel, Dentifrice - A combination of a dentifrice (formulation intended to clean and/or polish the teeth, and which may contain certain additional agents), and a gel. It is used with a toothbrush for the purpose of cleaning and polishing the teeth.
    Administration Route(s):
  • Dental - Administration to a tooth or teeth.
    • Active Ingredient(s):
  • POTASSIUM NITRATE 50 mg/g
  • SODIUM FLUORIDE 1.1 mg/g
    • Sample Package:
    No
    FDA Application Number:
    M022
    Marketing Category:
    OTC MONOGRAPH DRUG -
    Start Marketing Date:
    11-19-2023
    Listing Expiration Date:
    12-31-2025
    Exclude Flag:
    N
    Code Structure:

    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 disclaimer below.

    Frequently Asked Questions

    What is NDC 51206-311-02?

    The NDC Packaged Code 51206-311-02 is assigned to a package of 3 carton in 1 package, combination / 1 tube in 1 carton (51206-311-01) / 133 g in 1 tube of Opal By Opalescence Sensitivity, a human over the counter drug labeled by Ultradent Products, Inc.. The product's dosage form is gel, dentifrice and is administered via dental form.

    Is NDC 51206-311 included in the NDC Directory?

    Yes, Opal By Opalescence Sensitivity with product code 51206-311 is active and included in the NDC Directory. The product was first marketed by Ultradent Products, Inc. on November 19, 2023 and its listing in the NDC Directory is set to expire on December 31, 2025 if the product is not updated or renewed by the manufacturer.

    What is the 11-digit format for NDC 51206-311-02?

    The 11-digit format is 51206031102. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

    This package code is originally configured in a 5-3-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

    10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
    5-3-251206-311-025-4-251206-0311-02