NDC Package 35000-902-78 Colgate Max Fresh Clean Mint

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

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:
35000-902-78
Package Description:
1 TUBE in 1 CARTON / 221 g in 1 TUBE
Product Code:
Proprietary Name:
Colgate Max Fresh Clean Mint
Non-Proprietary Name:
Sodium Fluoride
Substance Name:
Sodium Fluoride
Usage Information:
Adults and children 2 years of age and olderbrush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or physicianchildren 2 to 6 yearsuse only a pea sized amount and supervise child's brushing and rinsing (to minimize swallowing)children under 2 yearsask a dentist or physician
11-Digit NDC Billing Format:
35000090278
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:
    Colgate-palmolive Company
    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):
    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:
    08-01-2011
    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.

    Other Product Packages

    The following packages are also available for this product:

    NDC Package CodePackage Description
    35000-902-601 TUBE in 1 CARTON / 170 g in 1 TUBE
    35000-902-631 TUBE in 1 CARTON / 178 g in 1 TUBE

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 35000-902-78?

    The NDC Packaged Code 35000-902-78 is assigned to a package of 1 tube in 1 carton / 221 g in 1 tube of Colgate Max Fresh Clean Mint, a human over the counter drug labeled by Colgate-palmolive Company. The product's dosage form is gel, dentifrice and is administered via dental form.

    Is NDC 35000-902 included in the NDC Directory?

    Yes, Colgate Max Fresh Clean Mint with product code 35000-902 is active and included in the NDC Directory. The product was first marketed by Colgate-palmolive Company on August 01, 2011 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 35000-902-78?

    The 11-digit format is 35000090278. 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
    5-3-235000-902-785-4-235000-0902-78