Sensodyne

Manufacturer
Haleon US Holdings LLC
Effective date
2025-12-01
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:18:43

Label at a glance#

ProductSensodyne Whiten and Shine
Active ingredientSTANNOUS FLUORIDE
Label structure11 sections

Indications and uses

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

Dosage and administration

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...

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

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

Purposes

OTC - PURPOSE SECTION

Anticavity

Antihypersensitivity

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

Stop use and ask a dentist if

OTC - STOP USE SECTION

  • 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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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

SPL UNCLASSIFIED SECTION

  • products containing stannous fluoride may produce 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.
  • do not store above 30°C (86°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

glycerin, PEG-8, hydrated silica, pentasodium triphosphate, perlite, flavor, sodium lauryl sulfate, silica, polyacrylic acid, cocamidopropyl betaine, sodium saccharin, blue 1

Questions or comments?

OTC - QUESTIONS SECTION

1-866-844-2797

Additional Information (Fresh Clean)

SPL UNCLASSIFIED SECTION

ALWAYS FOLLOW THE LABEL

SENSODYNE

CLINCAL REPAIR

CLINICALLY PROVEN

SENSITIVITY RELIEF

ACTIVATES

Formula activates as soon as you begin to brush your teeth*

REPAIRS

Forms a protective layer inside and over exposed sensitive areas** to block the nerves from sensitivity triggers

PROTECTS

Clinically proven to provide long-lasting sensitivity relief and help prevent the pain from coming back**

SUPERIOR CLEANING ACTION

through stain removal***

Gentle on sensitive teeth

*for substantial sensitivity relief in 3 days

**with continued twice daily brushing

***vs Sensodyne Repair & Protect Deep Repair

Additional Information (Whiten & Shine)

SPL UNCLASSIFIED SECTION

ALWAYS FOLLOW THE LABEL

SENSODYNE

CLINICAL REPAIR

CLINCALLY PROVEN

SENSITIVITY RELIEF

ACTIVATES

Formula activates as soon as you begin to brush your teeth*

REPAIRS

Forms a protective layer inside and over exposed sensitive areas** to block the nerves from sensitivity triggers

PROTECTS

Clinically proven to provide long-lasting sensitivity relief and help prevent the pain from coming back**

SUPERIOR WHITENING ACTION

through stain removal***

Gentle on sensitive teeth

*for substantial sensitivity relief in 3 days

**with continued twice daily brushing

***vs Sensodyne Repair & Protect Deep Repair

Principal Display Panel- Whiten & Shine

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NEW

HALEON

TOOTHPASTE FOR SENSITIVE TEETH AND CAVITY PREVENTION

SENSODYNE

STARTS TO REPAIR SENSITIVE AREAS OF THE TEETH AFTER 60 SEC*

CLINICAL REPAIR

REPARATIVE ACTION PROVEN TO RELIEVE SENSITIVITY

WHITEN & SHINE

NET WT 3.4 OZ (96.4 g)

Sensodyne Clinical Repair Whiten and Shine 3.4 oz
Sensodyne Clinical Repair Whiten and Shine 3.4 oz

Principal Display Panel- Fresh Clean

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NEW

HALEON

TOOTHPASTE FOR SENSTIVE TEETH AND CAVITY PREVENTION

SENSODYNE

STARTS TO REPAIR SENSTIVE AREAS OF TEETH AFTER 60 SEC*

CLINICAL REPAIR

REPARATIVE ACTION PROVEN TO RELIEVE SENSITIVITY

FRESH CLEAN

NET WT 3.4 OZ (96.4 g)

Sensodyne Clinical Repair Fresh Clean 3.4 oz.
Sensodyne Clinical Repair Fresh Clean 3.4 oz.

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
416784stannous fluoride 0.454 % (fluoride ion 0.16 % ) ToothpastePSN2
416784stannous fluoride 0.00454 MG/MG ToothpasteSCD2
416784stannous fluoride 0.454 % (fluoride ion 0.14 % ) ToothpasteSY2
416784stannous fluoride 0.454 % (fluoride ion 0.15 % ) ToothpasteSY2
416784stannous fluoride 0.454 % (fluoride ion 0.16 % ) ToothpasteSY2

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0135-5912-01SensodyneFresh Clean23 g in 1 TUBEPASTE, DENTIFRICE232
0135-5912-01SensodyneFresh Clean1 in 1 CARTONPASTE, DENTIFRICE12
0135-5912-02SensodyneFresh Clean1 in 1 CARTONPASTE, DENTIFRICE12
0135-5912-02SensodyneFresh Clean65 g in 1 TUBEPASTE, DENTIFRICE652
0135-5912-03SensodyneFresh Clean96 g in 1 TUBEPASTE, DENTIFRICE962
0135-5912-03SensodyneFresh Clean1 in 1 CARTONPASTE, DENTIFRICE12
0135-5913-01SensodyneWhiten and Shine65 g in 1 TUBEPASTE, DENTIFRICE652
0135-5913-01SensodyneWhiten and Shine1 in 1 CARTONPASTE, DENTIFRICE12
0135-5913-02SensodyneWhiten and Shine1 in 1 CARTONPASTE, DENTIFRICE12
0135-5913-02SensodyneWhiten and Shine96 g in 1 TUBEPASTE, DENTIFRICE962

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0135-59130135-5913-01, 0135-5913-02
0135-59120135-5912-01, 0135-5912-02, 0135-5912-03

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 24 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sensodyne Fresh CleanSTANNOUS FLUORIDEHaleon US Holdings LLC2d433ac1-3ddf-a2f4-e063-6394a90a91f82025-12-01WarningsExact identifier
ndc (package): 0135-5912-02
ndc (package): 0135-5913-02
ndc (package): 0135-5913-01
ndc (package): 0135-5912-01
ndc (package): 0135-5912-03
ndc (product): 0135-5912
ndc (product): 0135-5913
ndc11 (package): 00135591202
ndc11 (package): 00135591201
ndc11 (package): 00135591301
ndc11 (package): 00135591203
ndc11 (package): 00135591302
spl id: 401f46e0-14e4-a791-e063-6394a90aeb56
spl set id: 2d433ac1-3ddf-a2f4-e063-6394a90a91f8

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.