SENSODYNE

Manufacturer
Haleon US Holdings LLC
Effective date
2024-03-04
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:09:21

Label at a glance#

ProductSENSODYNE Advanced Whitening
Active ingredientPOTASSIUM NITRATE, SODIUM FLUORIDE
Label structure10 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...

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Potassium nitrate 5%

Sodium fluoride 0.25% (0.16% 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

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

  • Do not store above 30° C (86 °F)

Inactive ingredients (Advanced Whitening)

INACTIVE INGREDIENT SECTION

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

Questions or comments?

OTC - QUESTIONS SECTION

1-866-844-2797

Additional information

SPL UNCLASSIFIED SECTION

ALWAYS FOLLOW THE LABEL

What are sensitive teeth?

Lots of people have sensitive teeth. When enamel is worn away (through eating everyday acidic food or

drinks) or gums recede, the dentin underneath becomes exposed. This can lead to tooth sensitivity,

for example, with cold and hot food and drinks.

What does Sensodyne do?

Sensodyne provides daily care for sensitive teeth* plus all the benefits you would expect from a daily fluoride toothpaste - strong teeth and freshness.

*with twice daily brushing.

24/7 Sensitivity Protection*

+ Strong & Healthy Teeth

Use Sensodyne Advanced Whitening twice daily:

• Long lasting sensitivity protection* every day

• Contains fluoride to protect against cavities

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

©2020 GSK group of companies or its licensor.

Distributed by:

GSK Consumer Healthcare

Warren, NJ 07059

62000000057087

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 0135-0479-01

#1 DENTIST RECOMMENDED BRAND

SENSODYNE

Advanced Whitening

TOOTHPASTE FOR SENSITIVE TEETH AND CAVITY PREVENTION

24/7 Sensitivity Protection* + Strong & Healthy Teeth

NET WT 6.5 OZ (184 g)

Sensodyne Advanced Whitening 6.5 oz (184 g)Sensodyne Advanced Whitening 6.5 oz (184 g)

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
0135-0479-01SENSODYNEAdvanced Whitening184 g in 1 TUBEPASTE1843
0135-0479-01SENSODYNEAdvanced Whitening1 in 1 CARTONPASTE13
0135-0479-02SENSODYNEAdvanced Whitening184 g in 1 TUBEPASTE1843
0135-0479-02SENSODYNEAdvanced Whitening4 in 1 CARTONPASTE43

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0135-0479SENSODYNE ADVANCED WHITENING (POTASSIUM NITRATE) PASTE [HALEON US HOLDINGS LLC]3Current NDC, Legacy NDC, 4 package rows20240305_a06e2549-3c4e-4818-b53e-1dea6828219f.zip

Products#

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

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0135-04790135-0479-01, 0135-0479-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 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 Advanced WhiteningPOTASSIUM NITRATEHaleon US Holdings LLCa06e2549-3c4e-4818-b53e-1dea6828219f2024-03-04WarningsExact identifier
ndc (package): 0135-0479-01
ndc (package): 0135-0479-02
ndc (product): 0135-0479
ndc11 (package): 00135047902
ndc11 (package): 00135047901
spl id: 12d5e856-2c07-35b2-e063-6294a90a2d3b
spl set id: a06e2549-3c4e-4818-b53e-1dea6828219f

Reported adverse events (FAERS/openFDA)#

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