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  5. NDC Package Code: 70766-012-03 Plak Smacker Great White Shark Cool Berry Flavor Anti Cavity Fluoride Gel Tooth

NDC Package 70766-012-03 Plak Smacker Great White Shark Cool Berry Flavor Anti Cavity Fluoride Gel Tooth

Sodium Fluoride Paste, Dentifrice Dental - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Other Packages
    3. 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:
70766-012-03
Package Description:
144 TUBE in 1 BOX / 50 g in 1 TUBE
Product Code:
70766-012
Proprietary Name:
Plak Smacker Great White Shark Cool Berry Flavor Anti Cavity Fluoride Gel Tooth
Non-Proprietary Name:
Sodium Fluoride
Substance Name:
Sodium Fluoride
Usage Information:
Adults and children 2 years of age and older: Brush teeth thoroughly, preferrably after each meal or at least twice a day, or as directed by a dentist or a physicianDo not swallowTo minimize wallowing, use a pea sizes amount in children under 6 yearsSupervise children's brushing until good habits are establishedChildren under 2 years of age: consult a dentist or physician
11-Digit NDC Billing Format:
70766001203
NDC to RxNorm Crosswalk:
  • RxCUI: 416783 - sodium fluoride 0.24 % Toothpaste
  • RxCUI: 416783 - sodium fluoride 0.0024 MG/MG Toothpaste
  • RxCUI: 416783 - sodium fluoride 0.24 % (fluoride ion 0.13 % ) Toothpaste
  • RxCUI: 416783 - sodium fluoride 0.24 % (fluoride ion 0.14 % ) Toothpaste
  • RxCUI: 416783 - sodium fluoride 0.24 % (fluoride ion 0.15 % ) Toothpaste
    • Product Type:
    Human Otc Drug
    Labeler Name:
    Yangzhou Sion Commodity Co.,ltd
    Dosage Form:
    Paste, Dentifrice - A paste formulation intended to clean and/or polish the teeth, and which may contain certain additional agents.
    Administration Route(s):
  • Dental - Administration to a tooth or teeth.
    • Active Ingredient(s):
  • SODIUM FLUORIDE .1 g/100g
    • Sample Package:
    No
    FDA Application Number:
    M005
    Marketing Category:
    OTC MONOGRAPH DRUG -
    Start Marketing Date:
    01-04-2024
    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.

    Other Product Packages

    The following packages are also available for this product:

    NDC Package CodePackage Description
    70766-012-01144 TUBE in 1 BOX / 24 g in 1 TUBE
    70766-012-025 BOX in 1 CARTON / 24 TUBE in 1 BOX / 28 g in 1 TUBE
    70766-012-0472 TUBE in 1 BOX / 100 g in 1 TUBE
    70766-012-05144 TUBE in 1 BOX / 100 g in 1 TUBE
    70766-012-06480 TUBE in 1 BOX / 28 g in 1 TUBE
    70766-012-0772 TUBE in 1 BOX / 120 g in 1 TUBE
    70766-012-08144 TUBE in 1 BOX / 120 g in 1 TUBE

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 70766-012-03?

    The NDC Packaged Code 70766-012-03 is assigned to a package of 144 tube in 1 box / 50 g in 1 tube of Plak Smacker Great White Shark Cool Berry Flavor Anti Cavity Fluoride Gel Tooth, a human over the counter drug labeled by Yangzhou Sion Commodity Co.,ltd. The product's dosage form is paste, dentifrice and is administered via dental form.

    Is NDC 70766-012 included in the NDC Directory?

    Yes, Plak Smacker Great White Shark Cool Berry Flavor Anti Cavity Fluoride Gel Tooth with product code 70766-012 is active and included in the NDC Directory. The product was first marketed by Yangzhou Sion Commodity Co.,ltd on January 04, 2024 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 70766-012-03?

    The 11-digit format is 70766001203. 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
    5-3-270766-012-035-4-270766-0012-03