FDA.reportPublic FDA data

Sensodyne

Product NDC
0135-0703
11-digit product format
001350703
Labeler code
0135
Product ID
0135-0703_3869dfcb-a163-6dee-e063-6394a90a96ef
Type
HUMAN OTC DRUG
Nonproprietary name
Potassium nitrate, Sodium fluoride
Dosage form
PASTE
Route
ORAL
Labeler
Haleon US Holdings LLC
Application
M022
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-01-02
Substance
POTASSIUM NITRATE; SODIUM FLUORIDE
Active strength
50; 2.5 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
Brand name suffix
Clinical White Enamel Strengthening
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
POTASSIUM NITRATE50 mg/g
SODIUM FLUORIDE2.5 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
1086243Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
99037e59-53d6-492c-8fce-67641fc8efddAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0135-0703-01SensodyneClinical White Enamel Strengthening96.4 g in 1 TUBEPASTE96.43
0135-0703-01SensodyneClinical White Enamel Strengthening1 in 1 CARTONPASTE13
0135-0703-02SensodyneClinical White Enamel Strengthening62.5 g in 1 TUBEPASTE62.53
0135-0703-02SensodyneClinical White Enamel Strengthening1 in 1 CARTONPASTE13
0135-0703-05SensodyneClinical White Enamel Strengthening1 in 1 CARTONPASTE13
0135-0703-05SensodyneClinical White Enamel Strengthening156 g in 1 TUBEPASTE1563
0135-0703-53SensodyneClinical White Enamel Strengthening3 in 1 CARTONPASTE33
0135-0703-53SensodyneClinical White Enamel Strengthening156 g in 1 TUBEPASTE1563

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0135-0703SENSODYNE CLINICAL WHITE STAIN PROTECTOR (POTASSIUM NITRATE, SODIUM FLUORIDE) PASTE SENSODYNE CLINICAL WHITE ENAMEL STRENGTHENING (POTASSIUM NITRATE, SODIUM FLUORIDE) PASTE [HALEON US HOLDINGS LLC]2Current NDC, 8 package rows20240305_99037e59-53d6-492c-8fce-67641fc8efdd.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 6 of 40 · 786 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AHLO PRO Healthy GumsCETYLPYRIDINIUM CHLORIDEGervest USA Inc4f5a0ccb-26e5-ebb6-e063-6394a90abbc52026-04-13WarningsExact identifier
application number: M022
Crest Scope Original Clean MintCETYLPYRIDINIUM CHLORIDEThe Procter & Gamble Manufacturing Company4f1db6f4-acd7-a665-e063-6294a90a826b2026-04-10WarningsExact identifier
application number: M022
Sore ThroatPHENOL GLYCERINWalgreens1e845299-178e-49ce-9d08-7e9d548a5a6d2026-04-09WarningsExact identifier
application number: M022
Sore throat cherryPHENOLWalgreens67bed85e-e1e2-49ba-98d6-dfd4e1cd68562026-04-08WarningsExact identifier
application number: M022
Health-Tec Topical AnestheticBENZOCAINEDental Health Products, Inc.5eb437c5-a2af-4c0d-b7b9-9ab7d093db852026-04-06WarningsExact identifier
application number: M022
AntisepticEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLFamily Dollar (FAMILY WELLNESS)269b9e7f-c5c8-4023-a3ea-e39040ade2712026-04-06WarningsExact identifier
application number: M022
Health-Tec Topical AnestheticBENZOCAINEDental Health Products, Inc.c3fb6705-c647-4fe6-9aca-29735d01d8ea2026-04-02WarningsExact identifier
application number: M022
AntisepticEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLFamily Dollar (FAMILY WELLNESS)f061ec82-7f0e-4b93-afa6-ae9fe14ab4ea2026-04-01WarningsExact identifier
application number: M022
CloSYS Silver Healthy GumsCETYLPYRIDINIUM CHLORIDERowpar Pharmaceuticals, Inc.11fd3f31-ee0c-43d2-a856-929d1298277c2026-04-01WarningsExact identifier
application number: M022
Crest Pro-Health Bold Fresh BreathCETYLPYRIDINIUM CHLORIDEThe Procter & Gamble Manufacturing Company5692c0ce-a914-08c4-e063-6394a90adf152026-04-01WarningsExact identifier
application number: M022
Anticavity FluorideSODIUM FLUORIDE AND ACIDULATED PHOSPHATEFamily Dollar (FAMILY WELLNESS)1666fff6-9a8b-40f9-ae53-914152db386b2026-04-01WarningsExact identifier
application number: M022
Sodium Chloride Normal SaltSODIUM CHLORIDETWIN MED LLC10230c8a-e5e5-44f1-b41d-80930899d6b92026-03-31WarningsExact identifier
application number: M022
Sootheez Birthday CakePECTINPrimrose Candy Co.4e5d8234-0521-0c8a-e063-6294a90ae62d2026-03-31WarningsExact identifier
application number: M022
Sootheez Watermelon MintPECTINPrimrose Candy Co.4e5e4342-4647-ef25-e063-6394a90a1d132026-03-31WarningsExact identifier
application number: M022
PERIOGELXHYDROGEN PEROXIDEPERIO PROTECT, LLC4e5a67a0-f989-50df-e063-6394a90aae732026-03-31WarningsExact identifier
application number: M022
PeriogelHYDROGEN PEROXIDEPERIO PROTECT, LLC1f9686b1-eac2-65b7-e063-6394a90a74fb2026-03-31WarningsExact identifier
application number: M022
PERIOGELXHYDROGEN PEROXIDEPERIO PROTECT, LLC1f7ecd75-bb59-2f4f-e063-6294a90ace842026-03-31WarningsExact identifier
application number: M022
Baza ProtectZINC OXIDE AND DIMETHICONEColoplast Corped63df26-3879-46df-8e09-10be569b25be2026-03-31WarningsExact identifier
application number: M022
Benzocaine 20%BENZOCAINE 20%PAI Holdings, LLC dba PAI Pharma7fbce9a5-00dc-4a4a-8709-ab752bdf2f592026-03-25WarningsExact identifier
application number: M022
Kroger Extra WhiteningFLUORIDEKrogere704c690-1383-4cd6-be85-28bdd9ff936b2026-03-24WarningsExact identifier
application number: M022

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1086243potassium nitrate 5 % / sodium fluoride 0.25 % ToothpastePSN99037e59-53d6-492c-8fce-67641fc8efdd3
1086243potassium nitrate 0.05 MG/MG / sodium fluoride 0.0025 MG/MG ToothpasteSCD99037e59-53d6-492c-8fce-67641fc8efdd3
1086243K+ nitrate 0.05 MG/MG / Sodium Fluoride 0.0025 MG/MG ToothpasteSY99037e59-53d6-492c-8fce-67641fc8efdd3
1086243Pot nitrate 0.05 MG/MG / Sodium Fluoride 0.0025 MG/MG ToothpasteSY99037e59-53d6-492c-8fce-67641fc8efdd3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0135-0703-01001350703011 TUBE in 1 CARTON (0135-0703-01) / 96.4 g in 1 TUBE1 tube2024-01-02NoNoCurrent
0135-0703-02001350703021 TUBE in 1 CARTON (0135-0703-02) / 62.5 g in 1 TUBE1 tube2024-01-02NoNoCurrent
0135-0703-05001350703051 TUBE in 1 CARTON (0135-0703-05) / 156 g in 1 TUBE1 tube2025-06-01NoNoCurrent
0135-0703-53001350703533 TUBE in 1 CARTON (0135-0703-53) / 156 g in 1 TUBE3 tube2025-06-01NoNoCurrent