The NDC Code 0126-0022-92 is assigned to a package of 100 ml in 1 bottle of Prevident 5000 Enamel Protect, a human prescription drug labeled by Colgate Oral Pharmaceuticals, Inc.. The product's dosage form is gel, dentifrice and is administered via dental form.
||100 mL in 1 BOTTLE
||Prevident 5000 Enamel Protect 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.
||Sodium Fluoride And Potassium Nitrate 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.
||This medication is used to prevent cavities and to reduce pain from sensitive teeth (dentinal hypersensitivity). Sodium fluoride works by making the teeth stronger and more resistant to decay caused by acid and bacteria. Potassium nitrate works by calming the nerves in the teeth. Do not use this medication in children younger than 6 years old unless directed by your doctor/dentist. Some products are not recommended for use in children younger than 12 years. Ask your doctor or dentist for more details about using this product safely in children. Caregivers/parents should watch the child to make sure the child does not swallow the medication while brushing.
|11-Digit NDC Billing Format
||00126002292 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.
||ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
||Human Prescription Drug 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.
Colgate Oral Pharmaceuticals, Inc.
||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.
- Dental - Administration to a tooth or teeth.
- SODIUM FLUORIDE 5.8 mg/mL
- POTASSIUM NITRATE 57.5 mg/mL
||No Sample Package?
This field Indicates whether this package is a sample packaging or not.
||UNAPPROVED DRUG OTHER - 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.
|Start Marketing Date
||03-30-2011 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
||12-31-2022 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.
||N 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
- 0126 - Colgate Oral Pharmaceuticals, Inc.
- 0126-0022 - Prevident 5000 Enamel Protect
0126-0022-92 - 100 mL in 1 BOTTLE
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.
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