FDA.reportPublic FDA data

Sensodyne

Product NDC
0135-5468
11-digit product format
001355468
Labeler code
0135
Product ID
0135-5468_f193ec40-032f-42c7-81f1-029ec8989374
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
2024-12-31
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

Additional Listing Data#

Finished product
Yes
Brand name base
Sensodyne
Brand name suffix
Clinical White Intensive Clean
Listing expiration
2026-12-31

Active Ingredients#

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

Harmonized Identifiers#

Field, Values table
FieldValues
UniiRU45X2JN0Z, 8ZYQ1474W7
Rxcui1086243

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0135-5468-01SensodyneClinical White Intensive Clean1 in 1 CARTONPASTE11
0135-5468-01SensodyneClinical White Intensive Clean96.4 g in 1 TUBEPASTE96.41
0135-5468-03SensodyneClinical White Intensive Clean3 in 1 CARTONPASTE31
0135-5468-03SensodyneClinical White Intensive Clean96.4 g in 1 TUBEPASTE96.41

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0135-5468SENSODYNE CLINICAL WHITE INTENSIVE CLEAN (POTASSIUM NITRATE, SODIUM FLUORIDE) PASTE [HALEON US HOLDINGS LLC]1Current NDC, 4 package rows20250101_f193ec40-032f-42c7-81f1-029ec8989374.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1086243potassium nitrate 5 % / sodium fluoride 0.25 % ToothpastePSNf193ec40-032f-42c7-81f1-029ec89893741
1086243potassium nitrate 0.05 MG/MG / sodium fluoride 0.0025 MG/MG ToothpasteSCDf193ec40-032f-42c7-81f1-029ec89893741
1086243K+ nitrate 0.05 MG/MG / Sodium Fluoride 0.0025 MG/MG ToothpasteSYf193ec40-032f-42c7-81f1-029ec89893741
1086243Pot nitrate 0.05 MG/MG / Sodium Fluoride 0.0025 MG/MG ToothpasteSYf193ec40-032f-42c7-81f1-029ec89893741

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0135-5468-01001355468011 TUBE in 1 CARTON (0135-5468-01) / 96.4 g in 1 TUBE1 tube2024-12-31NoNoHistorical
0135-5468-03001355468033 TUBE in 1 CARTON (0135-5468-03) / 96.4 g in 1 TUBE3 tube2024-12-31NoNoHistorical