Sensodyne

Product NDC
0135-0643
11-digit product format
001350643
Labeler code
0135
Product ID
0135-0643_12d8be79-e302-098d-e063-6394a90aa50d
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
2023-04-03
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
Extra Whitening Cool Mint
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
Rxcui1038929

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0135-0643-01SensodyneExtra Whitening Cool Mint1 in 1 CARTONPASTE12
0135-0643-01SensodyneExtra Whitening Cool Mint113 g in 1 TUBEPASTE1132

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0135-0643SENSODYNE EXTRA WHITENING COOL MINT (POTASSIUM NITRATE AND SODIUM FLUORIDE) PASTE [HALEON US HOLDINGS LLC]2Current NDC, 2 package rows20240305_c977f2c4-e0f3-44d2-aa7a-845f0583af3e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1038929potassium nitrate 5 % / sodium fluoride 0.24 % ToothpastePSNc977f2c4-e0f3-44d2-aa7a-845f0583af3e2
1038929potassium nitrate 0.05 MG/MG / sodium fluoride 0.0024 MG/MG ToothpasteSCDc977f2c4-e0f3-44d2-aa7a-845f0583af3e2
1038929K+ nitrate 0.05 MG/MG / Sodium Fluoride 0.0024 MG/MG ToothpasteSYc977f2c4-e0f3-44d2-aa7a-845f0583af3e2
1038929Pot nitrate 0.05 MG/MG / Sodium Fluoride 0.0024 MG/MG ToothpasteSYc977f2c4-e0f3-44d2-aa7a-845f0583af3e2
1038929potassium nitrate 5 % / sodium fluoride 0.24 % (fluoride ion 0.14 % ) ToothpasteSYc977f2c4-e0f3-44d2-aa7a-845f0583af3e2
1038929potassium nitrate 5 % / sodium fluoride 0.24 % (fluoride ion 0.15 % ) ToothpasteSYc977f2c4-e0f3-44d2-aa7a-845f0583af3e2
1038929potassium nitrate 5 % / sodium fluoride 0.24 % ToothpasteSYc977f2c4-e0f3-44d2-aa7a-845f0583af3e2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0135-0643-01001350643011 TUBE in 1 CARTON (0135-0643-01) / 113 g in 1 TUBE1 tube2023-04-03NoNoHistorical