Drug Information

Product NDC: 0135-0557

Proprietary Name: BIOTENE

Non Proprietary Name: sodium fluoride

Active Ingredient(s):
  • 1.5 mg/g SODIUM FLUORIDE

Administration Route(s): ORAL

Dosage Form(s): PASTE

Labeler Information

Labeler Name: GlaxoSmithKline Consumer Healthcare Holdings (US) LLC
Product Type: HUMAN OTC DRUG
FDA Application Number: part355
Marketing Category: OTC MONOGRAPH FINAL
Start Marketing Date:7/15/2013

Package Information

No. Package Code Package Description Billing Unit
10135-0557-011 TUBE in 1 CARTON (0135-0557-01) > 121.9 g in 1 TUBEGM
20135-0557-021 TUBE in 1 CARTON (0135-0557-02) > 19.8 g in 1 TUBE

NDC Record

Field Name Field Value Definition
PRODUCT NDC0135-0557The 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 NAMEBIOTENEThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
PROPRIETARY NAME SUFFIXFresh Mint OriginalA suffix to the proprietary name, a value here should be appended to the ProprietaryName field to obtain the complete name of the product. This suffix is often used to distinguish characteristics of a product such as extended release (“XR”) or sleep aid (“PM”). Although many companies follow certain naming conventions for suffices, there is no recognized standard.
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 NAMEPASTEThe 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 DATE7/15/2013This is the date that the labeler indicates was the start of its marketing of the drug product.
MARKETING CATEGORY NAMEOTC MONOGRAPH FINALProduct 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.
APPLICATION NUMBERpart355This 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 NAMEGlaxoSmithKline Consumer Healthcare Holdings (US) LLCName of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAMESODIUM FLUORIDEThis is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

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This page was last updated on: 11/16/2020