FDA.reportPublic FDA data

Sensodyne

Product NDC
0135-5027
11-digit product format
001355027
Labeler code
0135
Product ID
0135-5027_12dcfebc-b604-ee53-e063-6294a90ab16a
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
2022-01-03
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
Nourish Healthy 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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0135-5027-01SensodyneNourish Healthy White1 in 1 CARTONPASTE12
0135-5027-01SensodyneNourish Healthy White113 g in 1 TUBEPASTE1132
0135-5027-02SensodyneNourish Healthy White1 in 1 CARTONPASTE12
0135-5027-02SensodyneNourish Healthy White77 g in 1 TUBEPASTE772

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0135-5027SENSODYNE NOURISH HEALTHY WHITE (POTASSIUM NITRATE AND SODIUM FLUORIDE) PASTE [HALEON US HOLDINGS LLC]2Current NDC, Legacy NDC, 4 package rows20240306_aca38560-2fd7-47be-9e93-2abc3214e856.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1086243potassium nitrate 5 % / sodium fluoride 0.25 % ToothpastePSNaca38560-2fd7-47be-9e93-2abc3214e8562
1086243potassium nitrate 0.05 MG/MG / sodium fluoride 0.0025 MG/MG ToothpasteSCDaca38560-2fd7-47be-9e93-2abc3214e8562
1086243K+ nitrate 0.05 MG/MG / Sodium Fluoride 0.0025 MG/MG ToothpasteSYaca38560-2fd7-47be-9e93-2abc3214e8562
1086243Pot nitrate 0.05 MG/MG / Sodium Fluoride 0.0025 MG/MG ToothpasteSYaca38560-2fd7-47be-9e93-2abc3214e8562

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0135-5027-01001355027011 TUBE in 1 CARTON (0135-5027-01) / 113 g in 1 TUBE1 tube2022-01-030000-00-00NoNoCurrent
0135-5027-02001355027021 TUBE in 1 CARTON (0135-5027-02) / 77 g in 1 TUBE1 tube2022-01-030000-00-00NoNoCurrent