SENSODYNE

Product NDC
0135-5029
11-digit product format
001355029
Labeler code
0135
Product ID
0135-5029_1d136fd0-e761-deab-e063-6394a90a2452
Type
HUMAN OTC DRUG
Nonproprietary name
potassium nitrate
Dosage form
PASTE
Route
ORAL
Labeler
Haleon US Holdings LLC
Application
M022
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-07-12
Substance
POTASSIUM NITRATE; SODIUM FLUORIDE
Active strength
50; 1.11 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
Advanced Whitening Plus
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
POTASSIUM NITRATE50 mg/g
SODIUM FLUORIDE1.11 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiRU45X2JN0Z, 8ZYQ1474W7
Rxcui1086243

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0135-5029-01SENSODYNEAdvanced Whitening Plus184 g in 1 TUBEPASTE1841
0135-5029-01SENSODYNEAdvanced Whitening Plus4 in 1 CARTONPASTE41

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0135-5029SENSODYNE ADVANCED WHITENING PLUS (POTASSIUM NITRATE) PASTE [HALEON US HOLDINGS LLC]1Current NDC, 2 package rows20240713_f757ccdd-b316-4799-a34a-10edbb73da6b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1086243potassium nitrate 5 % / sodium fluoride 0.25 % ToothpastePSNf757ccdd-b316-4799-a34a-10edbb73da6b1
1086243potassium nitrate 0.05 MG/MG / sodium fluoride 0.0025 MG/MG ToothpasteSCDf757ccdd-b316-4799-a34a-10edbb73da6b1
1086243K+ nitrate 0.05 MG/MG / Sodium Fluoride 0.0025 MG/MG ToothpasteSYf757ccdd-b316-4799-a34a-10edbb73da6b1
1086243Pot nitrate 0.05 MG/MG / Sodium Fluoride 0.0025 MG/MG ToothpasteSYf757ccdd-b316-4799-a34a-10edbb73da6b1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0135-5029-01001355029014 TUBE in 1 CARTON (0135-5029-01) / 184 g in 1 TUBE4 tube2024-07-12NoNoHistorical