57511-0102 NDC - FLUORIMAX 5000 SENSITIVE (1.1% SODIUM FLUORIDE WITH 5% POTASSIUM NITRATE TOOTHPASTE)

Drug Information

Product NDC: 57511-0102

Proprietary Name: FluoriMax 5000 Sensitive

Non Proprietary Name: 1.1% Sodium Fluoride with 5% Potassium Nitrate Toothpaste

Active Ingredient(s):
  • 5 g/100g POTASSIUM NITRATE;
  • 1.1 g/100g SODIUM FLUORIDE


Administration Route(s): TOPICAL

Dosage Form(s): PASTE, DENTIFRICE

Labeler Information

Labeler Name: Elevate Oral Care
Product Type: HUMAN OTC DRUG
FDA Application Number:
Marketing Category: UNAPPROVED DRUG OTHER
Start Marketing Date:8/1/2017
End Marketing Date:10/31/2024

Package Information

No. Package Code Package Description Billing Unit
157511-0102-396 g in 1 TUBE (57511-0102-3)

NDC Record

Field Name Field Value Definition
PRODUCT NDC57511-0102The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
PRODUCT TYPE NAMEHUMAN OTC DRUGIndicates 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.
PROPRIETARY NAMEFluoriMax 5000 SensitiveThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
NON PROPRIETARY NAME1.1% Sodium Fluoride with 5% Potassium Nitrate ToothpasteThe non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
DOSAGE FORM NAMEPASTE, DENTIFRICEThe translation of the dosage form Code submitted by the firm.
ROUTE NAMETOPICALThe translation of the route code submitted by the firm, indicating route of administration.
START MARKETING DATE8/1/2017This is the date that the labeler indicates was the start of its marketing of the drug product.
END MARKETING DATE10/31/2024This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.
MARKETING CATEGORY NAMEUNAPPROVED DRUG OTHERProduct 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.
LABELER NAMEElevate Oral CareName of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAMEPOTASSIUM NITRATE; SODIUM FLUORIDEAn active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
ACTIVE NUMERATOR STRENGTH5; 1.1 
ACTIVE INGRED UNITg/100g; g/100g 

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This page was last updated on: 2/1/2023