NDC 0135-0548 Sensodyne Repair And Protect
Stannous Fluoride Paste Oral

Product Information

What is NDC 0135-0548?

The NDC code 0135-0548 is assigned by the FDA to the product Sensodyne Repair And Protect which is a human over the counter drug product labeled by Glaxosmithkline Consumer Healthcare Holdings (us) Llc. The generic name of Sensodyne Repair And Protect is stannous fluoride. The product's dosage form is paste and is administered via oral form. The product is distributed in 2 packages with assigned NDC codes 0135-0548-01 1 tube in 1 carton / 23 g in 1 tube, 0135-0548-02 1 tube in 1 carton / 96.4 g in 1 tube. This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information, RxNorm crosswalk and the complete product label.

NDC Product Code0135-0548
Proprietary Name 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.		Sensodyne Repair And Protect
Non-Proprietary Name 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.		Stannous Fluoride
Product Type 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.		Human Otc Drug
Dosage FormPaste - A semisolid3 dosage form, containing a large proportion (20 – 50%) of solids finely dispersed in a fatty vehicle. This dosage form is generally for external application to the skin or mucous membranes.
Administration Route(s) What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.
  • Oral - Administration to or by way of the mouth.
Product Labeler Information What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.		Glaxosmithkline Consumer Healthcare Holdings (us) Llc
Labeler Code0135
FDA Application Number What is the FDA Application Number?
This 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.		part356
Marketing Category 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.		OTC MONOGRAPH NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final.
Start Marketing Date What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.		06-28-2021
Listing Expiration Date 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.		12-31-2023
Exclude Flag 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". 		N
NDC Code Structure

What are the uses for Sensodyne Repair And Protect?


Product Characteristics

Flavor(s)MINT (C73404)

Product Packages

NDC Code 0135-0548-01

Package Description: 1 TUBE in 1 CARTON / 23 g in 1 TUBE

NDC Code 0135-0548-02

Package Description: 1 TUBE in 1 CARTON / 96.4 g in 1 TUBE

Product Details

What are Sensodyne Repair And Protect Active Ingredients?

An 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.

Sensodyne Repair And Protect Active Ingredients UNII Codes

NDC to RxNorm Crosswalk

What is RxNorm? RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:
  • RxCUI: 416784 - stannous fluoride 0.454 % (fluoride ion 0.16 % ) Toothpaste
  • RxCUI: 416784 - stannous fluoride 0.00454 MG/MG Toothpaste
  • RxCUI: 416784 - stannous fluoride 0.454 % (fluoride ion 0.14 % ) Toothpaste
  • RxCUI: 416784 - stannous fluoride 0.454 % (fluoride ion 0.15 % ) Toothpaste

Sensodyne Repair And Protect Inactive Ingredients UNII Codes

The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

* Please review the disclaimer below.

Sensodyne Repair And Protect Product Label

FDA filings in the form of structured product labels are documents that include all published material associated whith this product. Product label information includes data like indications and usage generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Label Table of Contents



Active Ingredient



Stannous fluoride 0.454% (0.15% w/v fluoride ion)


Purposes



Anticavity, Antihypersensitivity


Uses



  • •aids in the prevention of dental cavities
  • •builds increasing protection against painful sensitivity of the teeth to cold, heat , acids, sweets or contact

When Using This Product,



if irritation occurs discontinue use


Stop Use And Ask A Dentist If:



  • •the problem persists or worsens. Sensitive teeth may indicate a serious problem that may need prompt care by a dentist
  • •pain/sensitivity still persists after 4 weeks of use

Keep Out Of Reach Of Children.



If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.


Directions



  • •adults and children 12 years of age and older:
    • •apply at least a 1-inch strip of the product onto a soft bristle toothbrush
    • •brush teeth thoroughly for at least 1 minute twice a day (morning and evening), and not more than 3 times a day, or as recommended by a dentist or doctor. Make sure to brush all sensitive areas of the teeth. Minimize swallowing. Spit out after brushing.
    • •children under 12 years of age: consult a dentist or doctor

Other Information



  • •products containing stannous fluoride may product surface staining of the teeth. Adequate toothbrushing may prevent these stains which are not harmful or permanent and may be removed by your dentist.
  • •this product is specifically formulated to help prevent staining
  • •store below 30°C (86°F)

Inactive Ingredients (Regular)



glycerin, PEG-8, hydrated silica, pentasodium triphosphate, sodium lauryl sulfate, flavor, titanium dioxide, polyacrylic acid, cocamidopropyl betaine, sodium saccharin


Inactive Ingredients (Extra Fresh)



glycerin, PEG-8, hydrated silica, pentasodium triphosphate, flavor, sodium lauryl sulfate, titanium dioxide, polyacrylic acid, sodium saccharin, cocamidopropyl betaine


Inactive Ingredients (Whitening)



glycerin, PEG-8, hydrated silica, pentasodium triphosphate, flavor, sodium lauryl sulfate, titanium dioxide, polyacrylic acid, cocamidopropyl betaine, sodium saccharin


Questions Or Comments?



call toll-free 1-866-844-2797


Principal Display Panel



NDC 0135-0548-02

SENSODYNE®

WITH FLUORIDE

DAILY REPAIR* TOOTHPASTE

TOOTHPASTE FOR SENSITIVE TEETH & CAVITY PROTECTION

NET WT 3.4 oz (96.4g)

#1 Dentist Recommended Brand

9 OUT OF 10 DENTISTS RECOMMENDED BRAND

REPAIR & PROTECT

Proven relief and protection from sensitivity pain*

Daily protection for sensitive teeth*

Contains fluoride for cavity protection

Helps keep breath minty fresh

Helps whiten enamel

Exposed dentin

Repairing layer protects against sensitivity*

Sensodyne® Repair and Protect toothpaste helps repair* the sensitive areas of your teeth.

#1 Dentist Recommended Brand for Sensitive Teeth

Why use Sensodyne® Repair and Protect?

Now there is a Sensodyne® toothpaste that can help repair sensitive areas of your teeth. The active ingredient in Sensodyne® Repair & Protect acts to build a repairing layer over the vulnerable sensitive areas of your teeth, helping to protect you from pain. It is also specially formulated to help whiten enamel and prevent staining. With regular use, Sensodyne® Repair Protect provides proven relief from sensitivity*.

*With twice daily brushing

ALWAYS FOLLOW THE LABEL

Trademarks are owned by or Licensed to the GSK group of companies

©2014 GSK

Distributed by:

GSK Consumer Healthcare

Warren, NJ 07059

104999XB

NDC 0135-0547-02

SENSODYNE®

WITH FLUORIDE

DAILY REPAIR* TOOTHPASTE

TOOTHPASTE FOR SENSITIVE TEETH & CAVITY PROTECTION

NET WT 3.4 oz (96.4g)

#1 Dentist Recommended Brand

9 OUT OF 10 DENTISTS RECOMMENDED BRAND

EXTRA FRESH

REPAIR & PROTECT

Proven relief and protection from sensitivity pain*

Daily protection for sensitive teeth*

Contains fluoride for cavity protection

Leaves your mouth feeling clean and fresh

Helps whiten enamel

Exposed dentin

Repairing layer protects against sensitivity*

Sensodyne® Repair and Protect toothpaste helps repair* the sensitive areas of your teeth.

#1 Dentist Recommended Brand for Sensitive Teeth

Why use Sensodyne® Repair and Protect?

Now there is a Sensodyne® toothpaste that can help repair* sensitive areas of your teeth. The active ingredient in Sensodyne® Repair & Protect acts to build a repairing layer over the vulnerable sensitive areas of your teeth, helping to protect you from pain. It is also specially formulated to help whiten enamel and prevent staining. With regular use, Sensodyne® Repair Protect provides proven relief from sensitivity*.

*With twice daily brushing

ALWAYS FOLLOW THE LABEL

Trademarks are owned by or Licensed to the GSK group of companies.

©2014 GSK

GSK Consumer Healthcare

Warren, NJ 07059

105710XA

NDC 0135-0575-01

SENSODYNE®

WITH FLUORIDE

TOOTHPASTE FOR SENSITIVE TEETH & CAVITY PROTECTION

REPAIR & PROTECT

WHITENING

NET WT 3.4 oz (96.4g)

DAILY REPAIR* TOOTHPASTE

#1 Dentist Recommended Brand

9 OUT OF 10 DENTISTS RECOMMENDED BRAND

Proven relief and protection from sensitivity pain*

Daily protection for sensitive teeth*

Helps to remove stains for whiter teeth

Contains fluoride for cavity protection

Helps keep breath minty fresh

Sensodyne® Repair and Protect toothpaste helps repair* the sensitive areas of your teeth.

#1 Dentist Recommended Brand for Sensitive Teeth

Why use Sensodyne Repair and Protect Whitening toothpaste?

Sensodyne® Repair & Protect toothpaste helps repair sensitive areas of your teeth. The active ingredient in Sensodyne® Repair & Protect Whitening toothpaste acts to build a repairing layer over the vulnerable sensitive areas of your teeth, helping to protect you from pain. It is also specially formulated to whiten enamel and prevent staining. With regular use, Sensodyne® Repair Protect Whitening toothpaste provides proven relief from sensitivity*.

*With twice daily brushing

Trademarks are owned by or Licensed to the GSK group of companies

©2014 GSK

Distributed by:

GSK Consumer Healthcare

Warren, NJ 07059

106064XA

ALWAYS FOLLOW THE LABEL


* Please review the disclaimer below.