NDC Package 35000-982-15 Colgate Optic White Renewal High Impact White

Sodium Monofluorophosphate Paste, 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:
35000-982-15
Package Description:
1 TUBE in 1 CARTON / 20 g in 1 TUBE
Product Code:
Proprietary Name:
Colgate Optic White Renewal High Impact White
Non-Proprietary Name:
Sodium Monofluorophosphate
Substance Name:
Sodium Monofluorophosphate
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:
35000098215
NDC to RxNorm Crosswalk:
  • RxCUI: 545626 - sodium monofluorophosphate 0.76 % Toothpaste
  • RxCUI: 545626 - sodium monofluorophosphate 0.0076 MG/MG Toothpaste
  • RxCUI: 545626 - sodium monofluorophosphate 0.76 % (fluoride ion 0.12 % )Toothpaste
  • RxCUI: 545626 - sodium monofluorophosphate 0.76 % (fluoride ion 0.13 % )Toothpaste
  • RxCUI: 545626 - sodium monofluorophosphate 0.76 % (fluoride ion 0.14 % )Toothpaste
  • Product Type:
    Human Otc Drug
    Labeler Name:
    Colgate-palmolive Company
    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):
    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:
    11-04-2019
    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
    35000-982-411 TUBE in 1 CARTON / 116 g in 1 TUBE
    35000-982-431 TUBE in 1 CARTON / 121 g in 1 TUBE
    35000-982-622 TUBE in 1 CARTON / 85 g in 1 TUBE
    35000-982-631 TUBE in 1 CARTON / 85 g in 1 TUBE

    * Please review the disclaimer below.

    Frequently Asked Questions

    What is NDC 35000-982-15?

    The NDC Packaged Code 35000-982-15 is assigned to a package of 1 tube in 1 carton / 20 g in 1 tube of Colgate Optic White Renewal High Impact White, a human over the counter drug labeled by Colgate-palmolive Company. The product's dosage form is paste, dentifrice and is administered via dental form.

    Is NDC 35000-982 included in the NDC Directory?

    Yes, Colgate Optic White Renewal High Impact White with product code 35000-982 is active and included in the NDC Directory. The product was first marketed by Colgate-palmolive Company on November 04, 2019 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 35000-982-15?

    The 11-digit format is 35000098215. 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
    5-3-235000-982-155-4-235000-0982-15