FDA.reportPublic FDA data

SENSODYNE

Manufacturer
Haleon US Holdings LLC
Effective date
2024-03-07
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:09:34

Label at a glance#

ProductSENSODYNE Sensitivity Gum and Enamel Mint
Active ingredientSTANNOUS FLUORIDE
Label structure10 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 specially formulated to help prevent staining.
  • do not store above 25°C (77°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

Questions or comments?

OTC - QUESTIONS SECTION

1-866-844-2797

Additional Information

SPL UNCLASSIFIED SECTION

ALWAYS FOLLOW THE LABEL

SENSODYNE

SENSITIVITY
GUM &
ENAMEL

Gum recession and enamel wear are the two leading causes of sensitive teeth. Gum problems are caused by a build-up of plaque bacteria along the gum line. Enamel wear can be caused by acids in

everyday foods and drinks.

Sensodyne Sensitivity, Gum & Enamelis a daily toothpaste with a clinically proven ingredient to relieve sensitive teeth and improve gum health, while also strengthening the enamel.

1. Builds a protective layer over the sensitive areas
2. Formula with stannous fluoride targets & removes plaque bacteria** in between teeth & gumline.
3. Strengthens enamel surface and protects teeth from acids, while being gentle on enamel.

*with twice daily brushing.
**plaque bacteria associated with gingivitis to help reduce swollen, bleeding gums.

Trademarks owned or licensed by GSK. @2022 GSK or licensor.

Distributed by: GSK Consumer Healthcare
Warren, NJ 07059. Made in Germany

CARTON
RECYCLE

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

new

#1 Dentist RecommendED Brand

SENSODYNE

MINT
SENSITIVITY GUM & ENAMEL

FLUORIDE TOOTHPASTE FOR SENSITIVE TEETH,
ANTI-GINGIVITIS AND CAVITY PREVENTION

NEW WT 3.4 OZ (96.4 g)

20041 Front Carton

Sensodyne Sensitivity Gum & Enamel Mint 3.4 oz carton
Sensodyne Sensitivity Gum & Enamel Mint 3.4 oz carton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
416784stannous fluoride 0.454 % (fluoride ion 0.16 % ) ToothpastePSN4
416784stannous fluoride 0.00454 MG/MG ToothpasteSCD4
416784stannous fluoride 0.454 % (fluoride ion 0.14 % ) ToothpasteSY4
416784stannous fluoride 0.454 % (fluoride ion 0.15 % ) ToothpasteSY4
416784stannous fluoride 0.454 % (fluoride ion 0.16 % ) ToothpasteSY4

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0135-5022-01SENSODYNESensitivity Gum and Enamel Mint1 in 1 CARTONPASTE14
0135-5022-01SENSODYNESensitivity Gum and Enamel Mint96.4 g in 1 TUBEPASTE96.44
0135-5022-02SENSODYNESensitivity Gum and Enamel Mint65.2 g in 1 TUBEPASTE65.24
0135-5022-02SENSODYNESensitivity Gum and Enamel Mint1 in 1 CARTONPASTE14
0135-5022-03SENSODYNESensitivity Gum and Enamel Mint2 in 1 CARTONPASTE24
0135-5022-03SENSODYNESensitivity Gum and Enamel Mint96.4 g in 1 TUBEPASTE96.44

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0135-5022SENSODYNE SENSITIVITY GUM AND ENAMEL MINT (STANNOUS FLUORIDE) PASTE [HALEON US HOLDINGS LLC]4Current NDC, Legacy NDC, 6 package rows20240308_d4e9e5cf-d058-4c3f-ab5e-0b5a20a012e2.zip

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0135-50220135-5022-01, 0135-5022-02, 0135-5022-03

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
GLYCERINPDC6A3C0OXIACT
POLYETHYLENE GLYCOL 400B697894SGQIACT
HYDRATED SILICAY6O7T4G8P9IACT
SODIUM TRIPOLYPHOSPHATE, UNSPECIFIED FORM5HK03SA80JIACT
SODIUM LAURYL SULFATE368GB5141JIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
COCAMIDOPROPYL BETAINE5OCF3O11KXIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
STANNOUS FLUORIDE3FTR44B32QACTIM

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 Gum and Enamel MintSTANNOUS FLUORIDEHaleon US Holdings LLCd4e9e5cf-d058-4c3f-ab5e-0b5a20a012e22024-03-07WarningsExact identifier
ndc (package): 0135-5022-01
ndc (package): 0135-5022-03
ndc (package): 0135-5022-02
ndc (product): 0135-5022
ndc11 (package): 00135502203
ndc11 (package): 00135502202
ndc11 (package): 00135502201
spl id: 13128d65-3388-ef9b-e063-6394a90af6ff
spl set id: d4e9e5cf-d058-4c3f-ab5e-0b5a20a012e2

Reported adverse events (FAERS/openFDA)#

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