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  5. NDC Package Code: 62685-233-04 Orbitol Alpine Fresh Fluoride Whitening Toothpaste

NDC Package 62685-233-04 Orbitol Alpine Fresh Fluoride Whitening Toothpaste

Sodium Monofluorophosphate Paste 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:
62685-233-04
Package Description:
1 TUBE in 1 BOX / 145 g in 1 TUBE
Product Code:
62685-233
Proprietary Name:
Orbitol Alpine Fresh Fluoride Whitening Toothpaste
Non-Proprietary Name:
Sodium Monofluorophosphate
Substance Name:
Sodium Monofluorophosphate
Usage Information:
Adults and children 6 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 doctor. Instruct children under 12 years of age in good brushing and rinsing habits (to minimize swallowing). Supervise children as necessary until capable of using without supervision. Children under 6 years of age: Do not use unless directed by a dentist or doctor.
11-Digit NDC Billing Format:
62685023304
NDC to RxNorm Crosswalk:
  • RxCUI: 1048117 - sodium monofluorophosphate 0.8 % Toothpaste
  • RxCUI: 1048117 - sodium monofluorophosphate 0.008 MG/MG Toothpaste
  • RxCUI: 1048117 - sodium monofluorophosphate 0.0081 MG/MG Toothpaste
    • Product Type:
    Human Otc Drug
    Labeler Name:
    Tropical Degil Cosmetics Industries Ltd
    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(s):
  • Dental - Administration to a tooth or teeth.
    • Active Ingredient(s):
  • SODIUM MONOFLUOROPHOSPHATE .8 g/100g
    • Sample Package:
    No
    FDA Application Number:
    part355
    Marketing Category:
    OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph.
    Start Marketing Date:
    09-27-2021
    Listing Expiration Date:
    12-31-2024
    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 62685-233-04?

    The NDC Packaged Code 62685-233-04 is assigned to a package of 1 tube in 1 box / 145 g in 1 tube of Orbitol Alpine Fresh Fluoride Whitening Toothpaste, a human over the counter drug labeled by Tropical Degil Cosmetics Industries Ltd. The product's dosage form is paste and is administered via dental form.

    Is NDC 62685-233 included in the NDC Directory?

    Yes, Orbitol Alpine Fresh Fluoride Whitening Toothpaste with product code 62685-233 is active and included in the NDC Directory. The product was first marketed by Tropical Degil Cosmetics Industries Ltd on September 27, 2021 and its listing in the NDC Directory is set to expire on December 31, 2024 if the product is not updated or renewed by the manufacturer.

    What is the 11-digit format for NDC 62685-233-04?

    The 11-digit format is 62685023304. 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
    5-3-262685-233-045-4-262685-0233-04