11527-704 NDC - SODIUM FLUORIDE 5000 PPM SENSITIVE (SODIUM FLUORIDE1.1%, POTASSIUM NITRATE 5%)

Drug Information

Product NDC: 11527-704

Proprietary Name: Sodium Fluoride 5000 ppm Sensitive

Non Proprietary Name: Sodium Fluoride1.1%, Potassium Nitrate 5%

Active Ingredient(s):
  • 57.5 mg/mL POTASSIUM NITRATE;
  • 5.8 mg/mL SODIUM FLUORIDE


Administration Route(s): DENTAL

Dosage Form(s): GEL, DENTIFRICE

Labeler Information

Labeler Name: Sheffield Pharmaceuticals LLC
Product Type: HUMAN PRESCRIPTION DRUG
FDA Application Number:
Marketing Category: UNAPPROVED DRUG OTHER
Start Marketing Date:3/26/2020

Package Information

No. Package Code Package Description Billing Unit
111527-704-421 TUBE in 1 CARTON (11527-704-42) / 100 mL in 1 TUBEML

NDC Record

Field Name Field Value Definition
PRODUCT NDC11527-704The 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 PRESCRIPTION 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 NAMESodium Fluoride 5000 ppm 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 NAMESodium Fluoride1.1%, Potassium Nitrate 5%The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
DOSAGE FORM NAMEGEL, DENTIFRICEThe translation of the dosage form Code submitted by the firm.
ROUTE NAMEDENTALThe translation of the route code submitted by the firm, indicating route of administration.
START MARKETING DATE3/26/2020This is the date that the labeler indicates was the start of its marketing of the drug product.
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 NAMESheffield Pharmaceuticals LLCName 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 STRENGTH57.5; 5.8 
ACTIVE INGRED UNITmg/mL; mg/mL 

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