NDC 35000-899-95 Colgate Max Fresh Advanced Whitening
Sodium Fluoride Gel, Dentifrice Dental

Package Information

What is NDC 35000-899-95?

The NDC Code 35000-899-95 is assigned to a package of 1 tube in 1 carton / 178 g in 1 tube of Colgate Max Fresh Advanced Whitening, 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. The following table has all the important details about this NDC code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

Field Name Field Value
NDC Code 35000-899-95
Package Description 1 TUBE in 1 CARTON / 178 g in 1 TUBE
Product Code 35000-899
Proprietary Name What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
Colgate Max Fresh Advanced Whitening
Non-Proprietary Name What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
Sodium Fluoride
Usage Information Product Usage Information
The drug use information is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate. This information is not individual medical advice and does not substitute for the advice of a health care professional. Always ask a health care professional for complete information about this product and your specific health needs.
This product is used as Anticavity
11-Digit NDC Billing Format NDC Format for Billing
For insurance billing purposes the Centers for Medicare & Medicaid Services (CMS) created an 11 digit NDC derivative identifier. If the NDC Package code is less than 11 digits the code must be padded with leading zeros. The leading zeros must be added to the appropriate segment to create a 5-4-2 configuration.
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 0.15 % ) Toothpaste
  • RxCUI: 416783 - sodium fluoride 0.24 % (fluoride ion 0.13 % ) Toothpaste
  • RxCUI: 416783 - sodium fluoride 0.24 % (fluoride ion 0.14 % ) Toothpaste
  • Product Type What kind of product is this?
    Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.
    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 Sample Package?
    This field Indicates whether this package is a sample packaging or not.
    Marketing Category What is the Marketing Category?
    Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
    OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph.
    FDA Application Number What is the FDA Application Number?
    This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
    Start Marketing Date What is the Start Marketing Date?
    This is the date that the labeler indicates was the start of its marketing of the drug product.
    Listing Expiration Date What is the Listing Expiration Date?
    This is the date when the listing record will expire if not updated or certified by the product labeler.
    Exclude Flag What is the NDC Exclude Flag?
    This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".
    NDC 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 Colgate Max Fresh with product NDC 35000-899.

    NDC Package CodePackage Description
    35000-899-342 TUBE in 1 CARTON / 170 g in 1 TUBE
    35000-899-601 TUBE in 1 CARTON / 170 g in 1 TUBE

    * Please review the disclaimer below.