SENSODYNE

Manufacturer
Haleon US Holdings LLC
Effective date
2024-03-07
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 00:09:35

Label at a glance#

ProductSENSODYNE Sensitivity and Gum Mint
Active ingredientSTANNOUS FLUORIDE
Label structure15 sections

Indications and uses

aids in the prevention of dental cavities. helps control bleeding gums. helps interfere with harmful effects of plaque associated with gingivitis. 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, Antigingivitis, Antihypersensitivity

Uses

INDICATIONS & USAGE SECTION

  • aids in the prevention of dental cavities.
  • helps control bleeding gums.
  • helps interfere with harmful effects of plaque associated with gingivitis.
  • 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.
  • gingivitis, bleeding, or redness persists for more than 2 weeks.
  • you have painful or swollen gums, pus from the gum line, loose teeth, or increasing spacing between the teeth. These maybe signs or symptoms of periodontitis, a serious form of gum disease.

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 (Sensitivity & Gum Whitening)

INACTIVE INGREDIENT SECTION

glycerin, PEG-8, hydrated silica, pentasodium triphosphate, flavor, sodium lauryl sulfate, titanium dioxide, polyacrylic acid, cocamidopropyl betaine, sodium saccharin

Inactive ingredients (Sensitivity & Gum Mint)

INACTIVE INGREDIENT SECTION

glycerin, PEG-8, hydrated silica, pentasodium triphosphate, flavor, sodium lauryl sulfate, titanium dioxide, polyacrylic acid, cocamidopropyl betaine, sodium saccharin

Inactive ingredients (Clean & Fresh)

INACTIVE INGREDIENT SECTION

glycerin, PEG-8, hydrated silica, pentasodium triphosphate, flavor, sodium lauryl sulfate, titanium dioxide, polyacrylic acid, cocamidopropyl betaine, sodium saccharin

Questions or comments?

OTC - QUESTIONS SECTION

1-866-844-2797

Additional Information (Whitening)

SPL UNCLASSIFIED SECTION

ALWAYS FOLLOW THE LABEL

Dual Action for TOOTH SENSITIVITY & GUM PROBLEMS

SENSITIVE AREAS AND SWOLLEN, BLEEDING GUMS

BUILDS A PROTECTIVE LAYER OVER SENSITIVE AREAS

TARGETS AND HELPS REMOVE PLAQUE BACTERIA

RELIEVES TOOTH SENSITIVITY* AND IMPROVES GUM HEALTH

Why use Sensodyne Sensitivity & Gum?

Sensodyne Sensitivity & Gum contains a clinically proven ingredient to relieve tooth sensitivity and improve gum health. It builds a protective layer over sensitive areas, effectively relieving tooth sensitivity. It targets and removes plaque bacteria associated with gingivitis, to help reduce swollen, bleeding gums. You can deal with both these concerning problems with one specialist toothpaste. Sensodyne Sensitivity & Gum is a daily fluoride toothpaste.

*with twice daily brushing

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

©2023 Haleon group of companies or its licensor.

Distributed by: Haleon, Warren, NJ 07059

Pat. Info www.productpats.com

†Recycling facilities for this product may not exist in your area

CARTONRECYCLE

TUBERECYCLE

CAPCHECK LOCALLY†

Additional Information (Mint and Clean & Fresh)

SPL UNCLASSIFIED SECTION

SENSODYNE

SENSITIVITY & GUM

Tooth sensitivity & gum problems?

Many people with sensitive teeth also have gum problems. Tooth sensitivity can occur when exposed dentin comes into contact with cold, hot, sweet and sour. Early gum problems are caused by a build-up of plaque bacteria, which can lead to redness, swelling, and bleeding.

SENSITIVE AREAS AND SWOLLEN, BLEEDING GUMS

BUILDS A PROTECTIVE LAYER OVER SENSITIVE AREAS

TARGETS AND HELPS REMOVE PLAQUE BACTERIA

RELIEVES TOOTH SENSITIVITY* AND IMPROVES GUM HEALTH

Dual Action for TOOTH SENSITIVITY & GUM PROBLEMS

*with twice daily brushing

Why use Sensodyne Sensitivity & Gum?

Sensodyne Sensitivity & Gum contains a clinically proven ingredient to relieve tooth sensitivity and improve gum health. It builds a protective layer over sensitive areas, effectively relieving tooth sensitivity. It targets and removes plaque bacteria associated with gingivitis, to help reduce swollen, bleeding gums. You can deal with both these concerning problems with one specialist toothpaste. Sensodyne Sensitivity & Gum is a daily fluoride toothpaste.

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

©2023 Haleon group of companies or its licensor.

Distributed by: Haleon, Warren, NJ 07059

Pat. Info www.productpats.com

†Recycling facilities for this product may not exist in your area

CARTONRECYCLE

TUBERECYCLE

CAPCHECK LOCALLY†

Principal Display Panel (Whitening)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

#1 DENTIST RECOMMENDED BRAND

SENSODYNE

FLUORIDE TOOTHPASTE FOR SENSITIVE TEETH, ANTIGINGIVITIS AND CAVITY PROTECTION

WHITENING

SENSITIVITY & GUM

IMPROVES GUM HEALTH

NET WT 2.3 OZ (65.2 g)

62000000207518

Sensodyne Sensitivity Gum Whitening 65g
Sensodyne Sensitivity Gum Whitening 65g

Principal Display Panel (Mint)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

#1 DENTIST RECOMMENDED BRAND

SENSODYNE

FLUORIDE TOOTHPASTE FOR SENSITIVE TEETH, ANTIGINGIVITIS AND CAVITY PROTECTION

MINT

SENSITIVITY & GUM

IMPROVES GUM HEALTH

NET WT 3.4 OZ (96.4 g)

62000000207515

Sensodyne Sensitivity Gum Mint 96g
Sensodyne Sensitivity Gum Mint 96g

Principal Display Panel (Clean & Fresh)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

#1 DENTIST RECOMMENDED BRAND

SENSODYNE

FLUORIDE TOOTHPASTE FOR SENSITIVE TEETH, ANTIGINGIVITIS AND CAVITY PROTECTION

CLEAN & FRESH

SENSITIVITY & GUM

IMPROVES GUM HEALTH

NET WT 3.4 OZ (96.4 g)

62000000207513

Sensodyne Sensitivity Gum CleanFresh 96g
Sensodyne Sensitivity Gum CleanFresh 96g

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
416784stannous fluoride 0.454 % (fluoride ion 0.16 % ) ToothpastePSN6
416784stannous fluoride 0.00454 MG/MG ToothpasteSCD6
416784stannous fluoride 0.454 % (fluoride ion 0.14 % ) ToothpasteSY6
416784stannous fluoride 0.454 % (fluoride ion 0.15 % ) ToothpasteSY6
416784stannous fluoride 0.454 % (fluoride ion 0.16 % ) ToothpasteSY6

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0135-5023-01SENSODYNESensitivity and Gum Mint1 in 1 CARTONPASTE16
0135-5023-01SENSODYNESensitivity and Gum Mint96.4 g in 1 TUBEPASTE96.46
0135-5023-02SENSODYNESensitivity and Gum Mint23 g in 1 TUBEPASTE236
0135-5023-02SENSODYNESensitivity and Gum Mint1 in 1 CARTONPASTE16
0135-5023-03SENSODYNESensitivity and Gum Mint23 g in 1 TUBEPASTE236
0135-5023-04SENSODYNESensitivity and Gum Mint96.4 g in 1 TUBEPASTE96.46
0135-5023-04SENSODYNESensitivity and Gum Mint3 in 1 CARTONPASTE36
0135-5024-01SENSODYNESensitivity and Gum Whitening1 in 1 CARTONPASTE16
0135-5024-01SENSODYNESensitivity and Gum Whitening96.4 g in 1 TUBEPASTE96.46
0135-5024-02SENSODYNESensitivity and Gum Whitening65.2 g in 1 TUBEPASTE65.26
0135-5024-02SENSODYNESensitivity and Gum Whitening1 in 1 CARTONPASTE16
0135-5025-01SENSODYNESENSITIVITY AND GUM CLEAN AND FRESH96.4 g in 1 TUBEPASTE96.46
0135-5025-01SENSODYNESENSITIVITY AND GUM CLEAN AND FRESH1 in 1 CARTONPASTE16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0135-5023SENSODYNE SENSITIVITY AND GUM MINT (STANNOUS FLUORIDE) PASTE SENSODYNE SENSITIVITY AND GUM WHITENING (STANNOUS FLUORIDE) PASTE SENSODYNE SENSITIVITY AND GUM CLEAN AND FRESH (STANNOUS FLUORIDE) PASTE [HALEON US HOLDINGS LLC]6Current NDC, Legacy NDC, 7 package rows20240308_ed093acd-255c-40ff-a010-d276f5844453.zip
0135-5024SENSODYNE SENSITIVITY AND GUM MINT (STANNOUS FLUORIDE) PASTE SENSODYNE SENSITIVITY AND GUM WHITENING (STANNOUS FLUORIDE) PASTE SENSODYNE SENSITIVITY AND GUM CLEAN AND FRESH (STANNOUS FLUORIDE) PASTE [HALEON US HOLDINGS LLC]6Current NDC, Legacy NDC, 4 package rows20240308_ed093acd-255c-40ff-a010-d276f5844453.zip
0135-5025SENSODYNE SENSITIVITY AND GUM MINT (STANNOUS FLUORIDE) PASTE SENSODYNE SENSITIVITY AND GUM WHITENING (STANNOUS FLUORIDE) PASTE SENSODYNE SENSITIVITY AND GUM CLEAN AND FRESH (STANNOUS FLUORIDE) PASTE [HALEON US HOLDINGS LLC]6Current NDC, Legacy NDC, 2 package rows20240308_ed093acd-255c-40ff-a010-d276f5844453.zip

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 27 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 Sensitivity and Gum MintSTANNOUS FLUORIDEHaleon US Holdings LLCed093acd-255c-40ff-a010-d276f58444532024-03-07WarningsExact identifier
ndc (package): 0135-5023-01
ndc (package): 0135-5024-01
ndc (package): 0135-5024-02
ndc (package): 0135-5023-03
ndc (package): 0135-5023-02
ndc (package): 0135-5025-01
ndc (package): 0135-5023-04
ndc (product): 0135-5024
ndc (product): 0135-5025
ndc (product): 0135-5023
ndc11 (package): 00135502501
ndc11 (package): 00135502301
ndc11 (package): 00135502304
ndc11 (package): 00135502401
ndc11 (package): 00135502303
ndc11 (package): 00135502302
ndc11 (package): 00135502402
spl id: 13123f95-ce72-c317-e063-6394a90ac2d2
spl set id: ed093acd-255c-40ff-a010-d276f5844453

Reported adverse events (FAERS/openFDA)#

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