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  5. NDC Package Code: 51206-312-02 Opal By Opalescence Original

NDC Package 51206-312-02 Opal By Opalescence Original

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:
51206-312-02
Package Description:
3 CARTON in 1 PACKAGE, COMBINATION / 1 TUBE in 1 CARTON (51206-312-01) / 133 g in 1 TUBE
Product Code:
51206-312
Proprietary Name:
Opal By Opalescence Original
Non-Proprietary Name:
Sodium Fluoride
Substance Name:
Sodium Fluoride
Usage Information:
Adults and children 2 years of age and older: Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or doctor. Instruct children under 6 years of age in good brushing and rinsing habits (to minimize swallowing). Supervise children as necessary until capable of using without supervision.Children under 2 years of age: Consult a dentist or doctor.
11-Digit NDC Billing Format:
51206031202
NDC to RxNorm Crosswalk:
  • RxCUI: 1044547 - sodium fluoride 0.25 % Toothpaste
  • RxCUI: 1044547 - sodium fluoride 0.0025 MG/MG Toothpaste
  • RxCUI: 1044547 - sodium fluoride 0.25 % (fluoride ion 0.15 % ) 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):
  • SODIUM FLUORIDE 1.1 mg/g
    • Sample Package:
    No
    FDA Application Number:
    M021
    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 51206-312-02?

    The NDC Packaged Code 51206-312-02 is assigned to a package of 3 carton in 1 package, combination / 1 tube in 1 carton (51206-312-01) / 133 g in 1 tube of Opal By Opalescence Original, 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 51206-312 included in the NDC Directory?

    Yes, Opal By Opalescence Original with product code 51206-312 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 51206-312-02?

    The 11-digit format is 51206031202. 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
    5-3-251206-312-025-4-251206-0312-02