51316-205 NDC - CVS HEALTH CLINICAL WHITE STAIN PROTECTOR (SODIUM FLUORIDE)

Drug Information

  • Product NDC: 51316-205
  • Proprietary Name: CVS Health Clinical White Stain Protector
  • Non Proprietary Name: Sodium Fluoride
  • Active Ingredient(s): 5 g/100g POTASSIUM NITRATE; .15 g/100g SODIUM FLUORIDE
  • Administration Route(s): ORAL
  • Dosage Form(s): PASTE, DENTIFRICE

Labeler Information

Field Name Field Value
Labeler Name: CVS Pharmacy
Product Type: HUMAN OTC DRUG
FDA Application Number: M022
Marketing Category: OTC MONOGRAPH DRUG
Start Marketing Date:1/8/2026

Package Information

No. Package Code Package Description Billing Unit
151316-205-101 TUBE in 1 CARTON (51316-205-10) / 96.4 g in 1 TUBE

NDC Record

Field Name Field Value Definition
PRODUCT NDC51316-205The 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 NAMECVS Health Clinical White Stain ProtectorThe 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 FluorideThe 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 NAMEORALThe translation of the route code submitted by the firm, indicating route of administration.
START MARKETING DATE1/8/2026This is the date that the labeler indicates was the start of its marketing of the drug product.
MARKETING CATEGORY NAMEOTC MONOGRAPH DRUGThe 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.
APPLICATION NUMBERM022This 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.
LABELER NAMECVS PharmacyName 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; .15 
ACTIVE INGRED UNITg/100g; g/100g 

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This page was last updated on: 1/16/2026