NDC 0135-0529 Sensodyne Fresh Mint
Potassium Nitrate And Sodium Fluoride Paste Dental

Product Information

Product Code0135-0529
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 Fresh Mint
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.
Potassium Nitrate And Sodium 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.
  • Dental - Administration to a tooth or teeth.
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.
09-30-1990
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

Usage Information


Product Characteristics

Color(s)BLUE (C48333)
WHITE (C48325)
GREEN (C48329)
Flavor(s)MINT (C73404)

Product Packages

NDC 0135-0529-01

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

NDC 0135-0529-03

Package Description: 2 TUBE in 1 CARTON > 113 g in 1 TUBE

NDC 0135-0529-04

Package Description: 1 TUBE in 1 CARTON > 113 g in 1 TUBE

NDC 0135-0529-05

Package Description: 1 TUBE in 1 CARTON > 77 g in 1 TUBE

Product Details

Sensodyne Fresh Mint is a human over the counter drug product labeled by Glaxosmithkline Consumer Healthcare Holdings (us) Llc. The generic name of Sensodyne Fresh Mint is potassium nitrate and sodium fluoride. The product's dosage form is paste and is administered via dental form.


What are Sensodyne Fresh Mint Active Ingredients?

The following is the list of active ingredients in this product. 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.


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 code indicates a single concept unique identifier (RXCUI) is associated with this product:


Inactive Ingredient(s)

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.

  • WATER (UNII: 059QF0KO0R)
  • SORBITOL (UNII: 506T60A25R)
  • HYDRATED SILICA (UNII: Y6O7T4G8P9)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
  • XANTHAN GUM (UNII: TTV12P4NEE)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
  • SACCHARIN SODIUM (UNII: SB8ZUX40TY)
  • SODIUM HYDROXIDE (UNII: 55X04QC32I)
  • SUCRALOSE (UNII: 96K6UQ3ZD4)
  • FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
  • WATER (UNII: 059QF0KO0R)
  • HYDRATED SILICA (UNII: Y6O7T4G8P9)
  • SORBITOL (UNII: 506T60A25R)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • SODIUM TRIPOLYPHOSPHATE (UNII: 5HK03SA80J)
  • POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
  • SODIUM METHYL COCOYL TAURATE (UNII: JVL98CG53G)
  • COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
  • XANTHAN GUM (UNII: TTV12P4NEE)
  • SODIUM HYDROXIDE (UNII: 55X04QC32I)
  • SACCHARIN SODIUM (UNII: SB8ZUX40TY)
  • SUCRALOSE (UNII: 96K6UQ3ZD4)
  • WATER (UNII: 059QF0KO0R)
  • SORBITOL (UNII: 506T60A25R)
  • HYDRATED SILICA (UNII: Y6O7T4G8P9)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
  • XANTHAN GUM (UNII: TTV12P4NEE)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
  • SACCHARIN SODIUM (UNII: SB8ZUX40TY)
  • SODIUM HYDROXIDE (UNII: 55X04QC32I)
  • SUCRALOSE (UNII: 96K6UQ3ZD4)
  • D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
  • FD&C BLUE NO. 1 (UNII: H3R47K3TBD)


* Please review the disclaimer below.

Sensodyne Fresh Mint Labeling and Warnings

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.

Table of Contents



Active Ingredients



Potassium nitrate (5%)*

Sodium fluoride (0.15% w/v fluoride ion)


Purpose



Antihypersensitivity

Anticavity


Uses



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

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.


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 directed 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



  • •store below 30°C (86°F)

Inactive Ingredients (Cool Gel)



water, sorbitol, hydrated silica, glycerin, cocamidopropyl betaine, flavor, xanthan gum, sodium saccharin, sodium hydroxide, sucralose, FD&C Blue No. 1


Inactive Ingredients (Extra Whitening)



water, hydrated silica, sorbitol, glycerin, pentasodium triphosphate, PEG-8, flavor, titanium dioxide, sodium methyl cocoyl taurate, cocamidopropyl betaine, xanthan gum, sodium hydroxide, sodium saccharin, sucralose


Inactive Ingredients (Fresh Mint)



water, sorbitol, hydrated silica, glycerin, cocamidopropyl betaine, flavor, xanthan gum, titanium dioxide, sodium saccharin, sodium hydroxide, sucralose, yellow 10, blue 1


Inactive Ingredients (Fresh Impact)



water, sorbitol, hydrated silica, glycerin, cocamidopropyl betaine, flavor, xanthan gum, titanium dioxide, sodium saccharin, sodium hydroxide, sucralose, blue 1


Inactive Ingredients (Original)



water, sorbitol, glycerin, hydrated silica, cellulose gum, sodium methyl cocoyl taurate, silica, titanium dioxide, flavor, sodium saccharin, trisodium phosphate, red 28


Questions Or Comments?



call toll-free 1-866-844-2797 (English/Spanish) weekdays


Principal Display Panel



NDC 0135-0527-04

SENSODYNE®

MAXIMUM STRENGTH** WITH FLUORIDE

TOOTHPASTE FOR SENSITIVE TEETH AND CAVITY PREVENTION

NET WT 4.0 OZ (113g)

#1 Dentist Recommended Brand

9 OUT OF 10 DENTISTS RECOMMENDED BRAND

COOL GEL

FRESH FLAVOR

24/7 SENSITIVITY PROTECTION*

USE SENSODYNE®toothpaste whenever you normally brush:

Clinically proven ingredient reduces painful sensitivity

Provides sensitivity relief in as little as two weeks

Freshens breath with a cool minty flavor

Leaves your mouth feeling clean and fresh

Contains fluoride for cavity protection

#1 Dentist Recommended Brand for Sensitive Teeth†

†Dentists have been recommending Sensodyne® toothpaste for over 20 years. Brushing twice a day with Sensodyne® toothpaste builds a "shield of protection" against painful sensitivity. And, since Sensodyne® toothpaste has fluoride, it helps protect against cavities too.

*with twice daily brushing

**maximum FDA sensitivity active ingredient

SENSODYNE and package design elements are trademarks of the GlaxoSmithKline group of companies.

Visit us at: www.sensodyne.com

This product contains no sugar.

©2013 GlaxoSmithKline

GlaxoSmithKline

Consumer Healthcare, L.P.

Moon Township, PA 15108

Made in the U.S.A.

ALWAYS FOLLOW THE LABEL

102037XB

NDC 0135-0525-09

SENSODYNE®

MAXIMUM STRENGTH** WITH FLUORIDE

TOOTHPASTE FOR SENSITIVE TEETH AND CAVITY PREVENTION

NET WT 4.0 OZ (113g)

#1 Dentist Recommended Brand

9 OUT OF 10 DENTISTS RECOMMENDED BRAND

Extra Whitening

24/7 SENSITIVITY PROTECTION*

USE SENSODYNE®toothpaste whenever you normally brush:

Clinically proven ingredient reduces painful sensitivity

Provides sensitivity relief in as little as two weeks

Helps to remove stains for a whiter, brighter smile

Leaves your mouth feeling clean and fresh

Contains fluoride for cavity protection

#1 Dentist Recommended Brand for Sensitive Teeth†

†Dentists have been recommending Sensodyne® toothpaste for over 20 years. Brushing twice a day with Sensodyne® toothpaste builds a "shield of protection" against painful sensitivity. And, since Sensodyne® toothpaste has fluoride, it helps protect against cavities too.

*with twice daily brushing

**maximum FDA sensitivity active ingredient

SENSODYNE and package design elements are trademarks of the GlaxoSmithKline group of companies.

Visit us at: www.sensodyne.com

This product contains no sugar.

©2012 GlaxoSmithKline

GlaxoSmithKline

Consumer Healthcare, L.P.

Moon Township, PA 15108

Made in the U.S.A.

ALWAYS FOLLOW THE LABEL

102033XA

NDC 0135-0529-04

SENSODYNE®

MAXIMUM STRENGTH** WITH FLUORIDE

TOOTHPASTE FOR SENSITIVE TEETH AND CAVITY PREVENTION

NET WT 4.0 OZ (113g)

#1 Dentist Recommended Brand

9 OUT OF 10 DENTISTS RECOMMENDED BRAND

Fresh Mint

24/7 SENSITIVITY PROTECTION*

USE SENSODYNE®toothpaste whenever you normally brush:

Clinically proven ingredient reduces painful sensitivity

Provides sensitivity relief in as little as two weeks

Freshens breath with a fresh minty flavor

Leaves your mouth feeling clean and fresh

Contains fluoride for cavity protection

#1 Dentist Recommended Brand for Sensitive Teeth†

†Dentists have been recommending Sensodyne® toothpaste for over 20 years. Brushing twice a day with Sensodyne® toothpaste builds a "shield of protection" against painful sensitivity. And, since Sensodyne® toothpaste has fluoride, it helps protect against cavities too.

*with twice daily brushing

**maximum FDA sensitivity active ingredient

SENSODYNE and package design elements are trademarks of the GlaxoSmithKline group of companies.

Visit us at: www.sensodyne.com

This product contains no sugar.

©2012 GlaxoSmithKline

GlaxoSmithKline

Consumer Healthcare, L.P.

Moon Township, PA 15108

Made in the U.S.A.

ALWAYS FOLLOW THE LABEL

102028XA

NDC 0135-0528-04

SENSODYNE®

MAXIMUM STRENGTH** WITH FLUORIDE

TOOTHPASTE FOR SENSITIVE TEETH AND CAVITY PREVENTION

NET WT 4.0 OZ (113g)

#1 Dentist Recommended Brand

9 OUT OF 10 DENTISTS RECOMMENDED BRAND

Fresh Impact®

Keeps Breath Feeling Fresh

24/7 SENSITIVITY PROTECTION*

USE SENSODYNE®toothpaste whenever you normally brush:

Clinically proven ingredient reduces painful sensitivity

Provides sensitivity relief in as little as two weeks

Gives breath a long lasting freshening effect

Leaves your mouth feeling clean and fresh

Contains fluoride for cavity protection

#1 Dentist Recommended Brand for Sensitive Teeth†

†Dentists have been recommending Sensodyne® toothpaste for over 20 years. Brushing twice a day with Sensodyne® toothpaste builds a "shield of protection" against painful sensitivity. And, since Sensodyne® toothpaste has fluoride, it helps protect against cavities too.

*with twice daily brushing

**maximum FDA sensitivity active ingredient

SENSODYNE, FRESH IMPACT and package design elements are trademarks of the GlaxoSmithKline group of companies.

Visit us at: www.sensodyne.com

©2012 GlaxoSmithKline

GlaxoSmithKline

Consumer Healthcare, L.P.

Moon Township, PA 15108

“The ADA Council on Scientific Affairs’ Acceptance of Sensodyne Fresh Impact is based on its finding that the product is effective in helping to prevent and reduce tooth decay, when used as directed.”

This product contains no sugar, like all ADA-accepted toothpaste.

ALWAYS FOLLOW THE LABEL

102027XA

NDC 0135-0526-04

SENSODYNE®

MAXIMUM STRENGTH** WITH FLUORIDE

TOOTHPASTE FOR SENSITIVE TEETH AND CAVITY PREVENTION

NET WT 4.0 OZ (113g)

#1 Dentist Recommended Brand

9 OUT OF 10 DENTISTS RECOMMENDED BRAND

Original Flavor

24/7 SENSITIVITY PROTECTION*

USE SENSODYNE®toothpaste whenever you normally brush:

Clinically proven ingredient reduces painful sensitivity

Provides sensitivity relief in as little as two weeks

Leaves your mouth feeling clean and fresh

Contains fluoride for cavity protection

#1 Dentist Recommended Brand for Sensitive Teeth†

†Dentists have been recommending Sensodyne® toothpaste for over 20 years. Brushing twice a day with Sensodyne® toothpaste builds a "shield of protection" against painful sensitivity. And, since Sensodyne® toothpaste has fluoride, it helps protect against cavities too.

*with twice daily brushing

**maximum FDA sensitivity active ingredient

SENSODYNE and package design elements are trademarks of the GlaxoSmithKline group of companies.

Visit us at: www.sensodyne.com

This product contains no sugar.

©2012 GlaxoSmithKline

GlaxoSmithKline

Consumer Healthcare, L.P.

Moon Township, PA 15108

Made in the U.S.A.

ALWAYS FOLLOW THE LABEL

102036XA


* Please review the disclaimer below.