FDA.reportPublic FDA data

Sensodyne

Product NDC
0135-0702
11-digit product format
001350702
Labeler code
0135
Product ID
0135-0702_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 Stain Protector
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
8ZYQ1474W7Internal UNII lookup
RU45X2JN0ZInternal 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
0135-0702-01SensodyneClinical White Stain Protector96.4 g in 1 TUBEPASTE96.43
0135-0702-01SensodyneClinical White Stain Protector1 in 1 CARTONPASTE13
0135-0702-02SensodyneClinical White Stain Protector62.5 g in 1 TUBEPASTE62.53
0135-0702-02SensodyneClinical White Stain Protector1 in 1 CARTONPASTE13
0135-0702-03SensodyneClinical White Stain Protector1 in 1 CARTONPASTE13
0135-0702-03SensodyneClinical White Stain Protector23 g in 1 TUBEPASTE233
0135-0702-04SensodyneClinical White Stain Protector2 in 1 CARTONPASTE23
0135-0702-04SensodyneClinical White Stain Protector96.4 g in 1 TUBEPASTE96.43

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0135-0702SENSODYNE 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 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
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
0135-0702-01001350702011 TUBE in 1 CARTON (0135-0702-01) / 96.4 g in 1 TUBE1 tube2024-01-02NoNoCurrent
0135-0702-02001350702021 TUBE in 1 CARTON (0135-0702-02) / 62.5 g in 1 TUBE1 tube2024-01-02NoNoCurrent
0135-0702-03001350702031 TUBE in 1 CARTON (0135-0702-03) / 23 g in 1 TUBE1 tube2024-01-02NoNoCurrent
0135-0702-04001350702042 TUBE in 1 CARTON (0135-0702-04) / 96.4 g in 1 TUBE2 tube2024-01-02NoNoCurrent