FDA.reportPublic FDA data

Sensodyne

Manufacturer
Haleon US Holdings LLC
Effective date
2025-06-25
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 01:03:57

Label at a glance#

ProductSensodyne Clinical White Stain Protector
Active ingredientPOTASSIUM NITRATE, SODIUM FLUORIDE
Label structure12 sections

Indications and uses

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

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...

Storage and handling

do not store above 25°C (77°F)

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Potassium nitrate 5%
Sodium fluoride 0.25% (0.15% w/v fluoride ion)

Purposes

OTC - PURPOSE SECTION

Antihypersensitivity
Anticavity

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

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.

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

STORAGE AND HANDLING SECTION

  • do not store above 25°C (77°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

water, sorbitol, hydrated silica, glycerin, pentasodium triphosphate, PEG-8, sodium lauryl sulfate, flavor, alumina, titanium dioxide, xanthan gum, cocamidopropyl betaine, sodium hydroxide, carrageenan, sodium saccharin

Questions or comments?

OTC - QUESTIONS SECTION

1-866-844-2797

Additional Information (Enamel Strengthening)

SPL UNCLASSIFIED SECTION

ALWAYS FOLLOW THE LABEL

SENSODYNE CLINICAL WHITE

CLINICALLY PROVEN WHITENINGDESIGNED FOR SENSITIVE TEETH

WHITENING

Clinically proven whitening ingredients remove stains, polish teeth and help prevent future stains

SENSITIVITY PROTECTION

Clinically proven ingredients to protect against sensitivity and strengthen enamel.

Strengthens enamel

ENAMEL SAFE

* As shown in an 8 week study.
** With twice daily brushing.

Additional Information (Stain Protector)

SPL UNCLASSIFIED SECTION

ALWAYS FOLLOW THE LABEL

SENSODYNE

CLINICAL
WHITE

CLINICAL PROVEN
WHITENING
DESIGNED FOR
SENSITIVE TEETH

WHITENING
Clinically proven whitening ingredients remove stains, polish teeth and help prevent future stains

SENSITIVITY PROTECTION

Clinically proven ingredients to protect against sensitivity and strengthen enamel

Helps protect teeth from future stains

ENAMEL SAFE

* As shown in an 8 week study.
** With twice daily brushing.

Distributed by: Haleon, Warren, NJ 07059
Trademarks owned or licensed by Haleon.
© 2023 Haleon or licensor.

Principal Display Panel (Enamel Strengthening)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

HALEON

TOOTHPASE FOR SENSITIVE TEETH AND CAVITY PREVENTION

SENSODYNE

2 SHADES WHITER TEETH*

+24/7 SENSITIVITY PROTECTION**

CLINICAL

WHITE

#1 DENTIST RECOMMENDED BRAND FOR SENSITIVE TEETH

ENAMEL STRENGTHENING

NET WT 5.5 OZ (156 g)

Sensodyne Clinical White v3\Clin White Enam.jpg
Sensodyne Clinical White v3\Clin White Enam.jpg

Principal Display Panel (Stain Protector)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NEW

#1 DENTIST RECOMMENDED BRAND FOR SENSITIVE TEETH

SENSODYNE

TOOTHPASTE FOR SENSITIVE TEETH AND CAVITY PREVENTION

2 SHADES WHITER TEETH*
+24/7 SENSITIVITY PROTECTION**

CLINICAL
WHITE

STAIN PROTECTOR

NET WT 3.4 OZ (96.4 g)

Clinical White Stain Protector 96.4g
Clinical White Stain Protector 96.4g

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1086243potassium nitrate 5 % / sodium fluoride 0.25 % ToothpastePSN3
1086243potassium nitrate 0.05 MG/MG / sodium fluoride 0.0025 MG/MG ToothpasteSCD3
1086243K+ nitrate 0.05 MG/MG / Sodium Fluoride 0.0025 MG/MG ToothpasteSY3
1086243Pot nitrate 0.05 MG/MG / Sodium Fluoride 0.0025 MG/MG ToothpasteSY3

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0135-0702-01SensodyneClinical White Stain Protector96.4 g in 1 TUBEPASTE96.43
0135-0702-01SensodyneClinical White Stain Protector1 in 1 CARTONPASTE13
0135-0702-02SensodyneClinical White Stain Protector62.5 g in 1 TUBEPASTE62.53
0135-0702-02SensodyneClinical White Stain Protector1 in 1 CARTONPASTE13
0135-0702-03SensodyneClinical White Stain Protector1 in 1 CARTONPASTE13
0135-0702-03SensodyneClinical White Stain Protector23 g in 1 TUBEPASTE233
0135-0702-04SensodyneClinical White Stain Protector2 in 1 CARTONPASTE23
0135-0702-04SensodyneClinical White Stain Protector96.4 g in 1 TUBEPASTE96.43
0135-0703-01SensodyneClinical White Enamel Strengthening96.4 g in 1 TUBEPASTE96.43
0135-0703-01SensodyneClinical White Enamel Strengthening1 in 1 CARTONPASTE13
0135-0703-02SensodyneClinical White Enamel Strengthening62.5 g in 1 TUBEPASTE62.53
0135-0703-02SensodyneClinical White Enamel Strengthening1 in 1 CARTONPASTE13
0135-0703-05SensodyneClinical White Enamel Strengthening1 in 1 CARTONPASTE13
0135-0703-05SensodyneClinical White Enamel Strengthening156 g in 1 TUBEPASTE1563
0135-0703-53SensodyneClinical White Enamel Strengthening3 in 1 CARTONPASTE33
0135-0703-53SensodyneClinical White Enamel Strengthening156 g in 1 TUBEPASTE1563

Products#

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

DailyMed product names page 1 of 1 · 20 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0135-07030135-0703-01, 0135-0703-02, 0135-0703-05, 0135-0703-53
0135-07020135-0702-01, 0135-0702-02, 0135-0702-03, 0135-0702-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 30 matching rows.

Name, UNII, Kind table
NameUNIIKind
SORBITOL506T60A25RIACT
HYDRATED SILICAY6O7T4G8P9IACT
GLYCERINPDC6A3C0OXIACT
SODIUM TRIPOLYPHOSPHATE ANHYDROUS9SW4PFD2FZIACT
POLYETHYLENE GLYCOL 400B697894SGQIACT
SODIUM LAURYL SULFATE368GB5141JIACT
ALUMINUM OXIDELMI26O6933IACT
TITANIUM DIOXIDE15FIX9V2JPIACT
XANTHAN GUMTTV12P4NEEIACT
COCAMIDOPROPYL BETAINE5OCF3O11KXIACT
SODA LIME4RG4VJM6VGIACT
CARRAGEENAN5C69YCD2YJIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
POTASSIUM NITRATERU45X2JN0ZACTIB
SODIUM FLUORIDE8ZYQ1474W7ACTIM
SORBITOL506T60A25RIACT
HYDRATED SILICAY6O7T4G8P9IACT
GLYCERINPDC6A3C0OXIACT
SODIUM TRIPOLYPHOSPHATE ANHYDROUS9SW4PFD2FZIACT
POLYETHYLENE GLYCOL 400B697894SGQIACT
SODIUM LAURYL SULFATE368GB5141JIACT
ALUMINUM OXIDELMI26O6933IACT
TITANIUM DIOXIDE15FIX9V2JPIACT
XANTHAN GUMTTV12P4NEEIACT
COCAMIDOPROPYL BETAINE5OCF3O11KXIACT
SODA LIME4RG4VJM6VGIACT
CARRAGEENAN5C69YCD2YJIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
POTASSIUM NITRATERU45X2JN0ZACTIB
SODIUM FLUORIDE8ZYQ1474W7ACTIM

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 Clinical White Stain ProtectorPOTASSIUM NITRATE, SODIUM FLUORIDEHaleon US Holdings LLC99037e59-53d6-492c-8fce-67641fc8efdd2025-06-25WarningsExact identifier
ndc (package): 0135-0703-02
ndc (package): 0135-0702-02
ndc (package): 0135-0703-05
ndc (package): 0135-0703-53
ndc (package): 0135-0702-04
ndc (package): 0135-0703-01
ndc (package): 0135-0702-01
ndc (package): 0135-0702-03
ndc (product): 0135-0703
ndc (product): 0135-0702
ndc11 (package): 00135070301
ndc11 (package): 00135070302
ndc11 (package): 00135070203
ndc11 (package): 00135070204
ndc11 (package): 00135070305
ndc11 (package): 00135070353
ndc11 (package): 00135070201
ndc11 (package): 00135070202
spl id: 3869dfcb-a163-6dee-e063-6394a90a96ef
spl set id: 99037e59-53d6-492c-8fce-67641fc8efdd

Reported adverse events (FAERS/openFDA)#

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