FDA.reportPublic FDA data

Sensodyne

Product NDC
0135-5028
11-digit product format
001355028
Labeler code
0135
Product ID
0135-5028_12d9a4c3-8aa2-f2c4-e063-6294a90a405c
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
2022-01-24
Substance
POTASSIUM NITRATE; SODIUM FLUORIDE
Active strength
50; 1.15 mg/g; mg/g
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
POTASSIUM NITRATE50 mg/g
SODIUM FLUORIDE1.15 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiRU45X2JN0Z, 8ZYQ1474W7
Rxcui1086243

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0135-5028-012024-01-30C16284748780-11030e365-698c-111a-e063-dadaa90a10e2Drug Facts
0135-5028-022024-01-30C16284748780-11030e365-698c-111a-e063-dadaa90a10e2Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0135-5028-01SensodyneNatural white1 in 1 CARTONPASTE13
0135-5028-01SensodyneNatural white113 g in 1 TUBEPASTE1133
0135-5028-02SensodyneNatural white1 in 1 CARTONPASTE13
0135-5028-02SensodyneNatural white77 g in 1 TUBEPASTE773

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0135-5028SENSODYNE NATURAL WHITE (POTASSIUM NITRATE AND SODIUM FLUORIDE) PASTE [HALEON US HOLDINGS LLC]3Current NDC, Legacy NDC, 4 package rows20240305_911ac7e4-2b92-43d5-af0b-b5f741b088fb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1086243potassium nitrate 5 % / sodium fluoride 0.25 % ToothpastePSN911ac7e4-2b92-43d5-af0b-b5f741b088fb3
1086243potassium nitrate 0.05 MG/MG / sodium fluoride 0.0025 MG/MG ToothpasteSCD911ac7e4-2b92-43d5-af0b-b5f741b088fb3
1086243K+ nitrate 0.05 MG/MG / Sodium Fluoride 0.0025 MG/MG ToothpasteSY911ac7e4-2b92-43d5-af0b-b5f741b088fb3
1086243Pot nitrate 0.05 MG/MG / Sodium Fluoride 0.0025 MG/MG ToothpasteSY911ac7e4-2b92-43d5-af0b-b5f741b088fb3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0135-5028-01001355028011 TUBE in 1 CARTON (0135-5028-01) / 113 g in 1 TUBE1 tube2022-01-240000-00-00NoNoCurrent
0135-5028-02001355028021 TUBE in 1 CARTON (0135-5028-02) / 77 g in 1 TUBE1 tube2022-01-240000-00-00NoNoCurrent