FDA.reportPublic FDA data

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 00:09:23

Label at a glance#

ProductSensodyne Nourish Gently Soothing
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: Consult a dent...

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

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: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, flavor (contains aloe barbadensis extract and cocos nucifera (coconut) oil), sodium lauryl sulfate, xanthan gum, cocamidopropyl betaine, sodium saccharin, titanium dioxide

Questions or comments?

OTC - QUESTIONS SECTION

1-866-844-2797

Additional Information

SPL UNCLASSIFIED SECTION

ALWAYS FOLLOW THE LABEL

SENSODYNE nourish

WITH BIO-ACTIVE MINERALS

Brush twice daily for a healthier smile:

  • Strengthens & nourishes teeth
  • Helps prevent cavities
  • Protects from sensitivity*
  • Freshens breath

The Sensodyne Nourish rangewith bio-active minerals, strengthens and nourishes teeth while also protecting from sensitivity*. Our toothpaste is designed to provide the everyday nourishment your teeth to help protect the health of your mouth.

Gently Soothing:With trusted sensitivity protection*, our formulation, blended with aloe vera extract and natural mint, is designed for a clean sensation.

*with twice daily brush

Help us support the planet by recycling our packaging and being responsible with water usage.

CARTON

RECYCLE

TUBE

RECYCLE

LOT

See end of carton

Save Water

Turn off tap whilst brushing

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

©2021 GSK group of companies or its licensor.

Distributed by:

GSK Consumer Healthcare

Warren, NJ 07059

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 0135-5026-01

NEW

SENSODYNE

nourish

TOOTHPASTE FOR SENSITIVE TEETH AND CAVITY PREVENTION

NOURISH & STRENGTHEN TEETH FOR A HEALTHY MOUTH

gently soothing

aloe vera & natural mint

WITH BIO-ACTIVE MINERALS

NET WT 4.0 OZ (113 g)

62000000064835 Front Carton

Sensodyne Nourish Gently Soothing 4.0oz (113g) carton
Sensodyne Nourish Gently Soothing 4.0oz (113g) carton

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
0135-5026-01SensodyneNourish Gently Soothing113 g in 1 TUBEPASTE1133
0135-5026-01SensodyneNourish Gently Soothing1 in 1 CARTONPASTE13
0135-5026-02SensodyneNourish Gently Soothing1 in 1 CARTONPASTE13
0135-5026-02SensodyneNourish Gently Soothing23 g in 1 TUBEPASTE233
0135-5026-03SensodyneNourish Gently Soothing23 g in 1 TUBEPASTE233

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0135-5026SENSODYNE NOURISH GENTLY SOOTHING (POTASSIUM NITRATE AND SODIUM FLUORIDE) PASTE [HALEON US HOLDINGS LLC]3Current NDC, Legacy NDC, 5 package rows20240306_5403ab67-532c-4bdf-9b06-07b1866f37f1.zip

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0135-50260135-5026-01, 0135-5026-02, 0135-5026-03

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
NameUNIIKind
SACCHARIN SODIUMSB8ZUX40TYIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
POTASSIUM NITRATERU45X2JN0ZACTIB
SODIUM FLUORIDE8ZYQ1474W7ACTIM
WATER059QF0KO0RIACT
SORBITOL506T60A25RIACT
HYDRATED SILICAY6O7T4G8P9IACT
GLYCERINPDC6A3C0OXIACT
ALOE VERA LEAFZY81Z83H0XIACT
COCONUT OILQ9L0O73W7LIACT
SODIUM LAURYL SULFATE368GB5141JIACT
XANTHAN GUMTTV12P4NEEIACT
COCAMIDOPROPYL BETAINE5OCF3O11KXIACT

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 Nourish Gently SoothingPOTASSIUM NITRATE AND SODIUM FLUORIDEHaleon US Holdings LLC5403ab67-532c-4bdf-9b06-07b1866f37f12024-03-04WarningsExact identifier
ndc (package): 0135-5026-03
ndc (package): 0135-5026-01
ndc (package): 0135-5026-02
ndc (product): 0135-5026
ndc11 (package): 00135502601
ndc11 (package): 00135502602
ndc11 (package): 00135502603
spl id: 12dd5b4d-bc8b-7318-e063-6294a90a070d
spl set id: 5403ab67-532c-4bdf-9b06-07b1866f37f1

Reported adverse events (FAERS/openFDA)#

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