FDA.reportPublic FDA data

Sensodyne

Product NDC
0135-0550
11-digit product format
001350550
Labeler code
0135
Product ID
0135-0550_187e31fd-385b-91a4-e063-6394a90a9b1d
Type
HUMAN OTC DRUG
Nonproprietary name
potassium nitrate and sodium fluoride
Dosage form
PASTE
Route
DENTAL
Labeler
Haleon US Holdings LLC
Application
M022
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2004-02-17
Substance
POTASSIUM NITRATE; SODIUM FLUORIDE
Active strength
50; 1.1 mg/g; mg/g
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
Sensodyne
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
POTASSIUM NITRATE50 mg/g
SODIUM FLUORIDE1.1 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
RU45X2JN0ZInternal UNII lookup
8ZYQ1474W7Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1038841Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
9e8e7b9f-3ccd-4935-b886-93f3a5045b67Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0135-0550-04Sensodyne1 in 1 CARTONPASTE110
0135-0550-04Sensodyne113 g in 1 TUBEPASTE11310

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
POTASSIUM NITRATEACTIVE INGREDIENTRU45X2JN0ZSENSODYNE (POTASSIUM NITRATE AND SODIUM FLUORIDE) GEL [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]2
SODIUM FLUORIDEACTIVE INGREDIENT8ZYQ1474W7SENSODYNE (POTASSIUM NITRATE AND SODIUM FLUORIDE) GEL [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]2
FLUORIDE IONACTIVE MOIETYQ80VPU408OSENSODYNE (POTASSIUM NITRATE AND SODIUM FLUORIDE) GEL [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]2
NITRATE IONACTIVE MOIETYT93E9Y2844SENSODYNE (POTASSIUM NITRATE AND SODIUM FLUORIDE) GEL [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]2
COCAMIDOPROPYL BETAINEINACTIVE INGREDIENT5OCF3O11KXSENSODYNE (POTASSIUM NITRATE AND SODIUM FLUORIDE) GEL [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]2
GLYCERININACTIVE INGREDIENTPDC6A3C0OXSENSODYNE (POTASSIUM NITRATE AND SODIUM FLUORIDE) GEL [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]2
HYDRATED SILICAINACTIVE INGREDIENTY6O7T4G8P9SENSODYNE (POTASSIUM NITRATE AND SODIUM FLUORIDE) GEL [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]2
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQSENSODYNE (POTASSIUM NITRATE AND SODIUM FLUORIDE) GEL [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]2
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYSENSODYNE (POTASSIUM NITRATE AND SODIUM FLUORIDE) GEL [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]2
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32ISENSODYNE (POTASSIUM NITRATE AND SODIUM FLUORIDE) GEL [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]2
SODIUM METHYL COCOYL TAURATEINACTIVE INGREDIENTJVL98CG53GSENSODYNE (POTASSIUM NITRATE AND SODIUM FLUORIDE) GEL [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]2
SODIUM TRIPOLYPHOSPHATE ANHYDROUSINACTIVE INGREDIENT9SW4PFD2FZSENSODYNE (POTASSIUM NITRATE AND SODIUM FLUORIDE) GEL [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]2
SORBITOLINACTIVE INGREDIENT506T60A25RSENSODYNE (POTASSIUM NITRATE AND SODIUM FLUORIDE) GEL [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]2
SUCRALOSEINACTIVE INGREDIENT96K6UQ3ZD4SENSODYNE (POTASSIUM NITRATE AND SODIUM FLUORIDE) GEL [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPSENSODYNE (POTASSIUM NITRATE AND SODIUM FLUORIDE) GEL [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]2
WATERINACTIVE INGREDIENT059QF0KO0RSENSODYNE (POTASSIUM NITRATE AND SODIUM FLUORIDE) GEL [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]2
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEESENSODYNE (POTASSIUM NITRATE AND SODIUM FLUORIDE) GEL [GLAXOSMITHKLINE CONSUMER HEALTHCARE LP]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0135-0550SENSODYNE (POTASSIUM NITRATE AND SODIUM FLUORIDE) PASTE [HALEON US HOLDINGS LLC]10Current NDC, Legacy NDC, 2 package rows20240516_9e8e7b9f-3ccd-4935-b886-93f3a5045b67.zip

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 40 of 40 · 786 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
IoliteBENZOCAINEDharma Research, Inc.e4b2d22b-00b3-45a6-9b7d-8ee7195870592023-10-09WarningsExact identifier
application number: M022
IoliteBENZOCAINEDharma Research, Inc.a0e284f6-292f-4231-8596-f7cee4e0a12f2023-10-09WarningsExact identifier
application number: M022
HurriCaine Topical AnestheticBENZOCAINEBeutlich Pharmaceuticals, LLCfe92637a-c88a-f9dd-e053-6294a90a7fa32023-07-01WarningsExact identifier
application number: M022
HurriCaine Topical AnestheticBENZOCAINEBeutlich Pharmaceuticals, LLCc979e958-2042-471a-bf03-e84e686201062023-06-20WarningsExact identifier
application number: M022
Orajel Gum Pain 3X MedicatedBENZOCAINE, MENTHOL, ZINC CHLORIDEChurch & Dwight Co., Inc.9a1632ad-2b47-5653-e053-2995a90ae0d92023-01-20WarningsExact identifier
application number: M022
KOLORZ TOPICAL ANESTHETIC TRIPLE MINTBENZOCAINEDMG AMERICA, LLC0f90b227-f938-4e1a-a79e-1967b1a0477e2021-10-01WarningsExact identifier
application number: M022

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1038841potassium nitrate 5 % / sodium fluoride 0.15 % ToothpastePSN9e8e7b9f-3ccd-4935-b886-93f3a5045b6710
1038841potassium nitrate 0.05 MG/MG / sodium fluoride 0.0015 MG/MG ToothpasteSCD9e8e7b9f-3ccd-4935-b886-93f3a5045b6710
1038841K+ nitrate 0.05 MG/MG / Sodium Fluoride 0.0015 MG/MG ToothpasteSY9e8e7b9f-3ccd-4935-b886-93f3a5045b6710
1038841pot nitrate 0.05 MG/MG / sodium fluoride 0.0015 MG/MG gel ToothpasteSY9e8e7b9f-3ccd-4935-b886-93f3a5045b6710
1038841Pot nitrate 0.05 MG/MG / Sodium Fluoride 0.0015 MG/MG ToothpasteSY9e8e7b9f-3ccd-4935-b886-93f3a5045b6710
1038841potassium nitrate 5 % / sodium fluoride 0.15 % ToothpasteSY9e8e7b9f-3ccd-4935-b886-93f3a5045b6710

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0135-0550-04001350550041 TUBE in 1 CARTON (0135-0550-04) / 113 g in 1 TUBE1 tube2004-02-170000-00-00NoNoCurrent