FDA.reportPublic FDA data

Opalescence Whitening Sensitivity Relief

Product NDC
51206-315
11-digit product format
512060315
Labeler code
51206
Product ID
51206-315_4ed2fdc3-48ea-c51f-e063-6394a90afe28
Type
HUMAN OTC DRUG
Nonproprietary name
Potassium Nitrate and Sodium Fluoride
Dosage form
GEL, DENTIFRICE
Route
DENTAL
Labeler
Ultradent Products, Inc.
Application
M022
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-10-08
Substance
POTASSIUM NITRATE; SODIUM FLUORIDE
Active strength
50; 1.1 mg/g; mg/g
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Opalescence Whitening Sensitivity Relief
Listing expiration
2027-12-31

Active Ingredients#

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

Harmonized Identifiers#

Field, Values table
FieldValues
UniiRU45X2JN0Z, 8ZYQ1474W7
Rxcui1038929

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51206-315-01Opalescence Whitening Sensitivity Relief1 in 1 CARTONGEL, DENTIFRICE12
51206-315-01Opalescence Whitening Sensitivity Relief133 g in 1 TUBEGEL, DENTIFRICE1332
51206-315-02Opalescence Whitening Sensitivity Relief1 in 1 CARTONGEL, DENTIFRICE12
51206-315-02Opalescence Whitening Sensitivity Relief12 in 1 PACKAGE, COMBINATIONGEL, DENTIFRICE122
51206-315-03Opalescence Whitening Sensitivity Relief28 g in 1 TUBEGEL, DENTIFRICE282
51206-315-03Opalescence Whitening Sensitivity Relief1 in 1 CARTONGEL, DENTIFRICE12
51206-315-04Opalescence Whitening Sensitivity Relief1 in 1 CARTONGEL, DENTIFRICE12
51206-315-04Opalescence Whitening Sensitivity Relief24 in 1 PACKAGE, COMBINATIONGEL, DENTIFRICE242
51206-315-05Opalescence Whitening Sensitivity Relief1 in 1 CARTONGEL, DENTIFRICE12
51206-315-05Opalescence Whitening Sensitivity Relief48 in 1 PACKAGE, COMBINATIONGEL, DENTIFRICE482

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1038929potassium nitrate 5 % / sodium fluoride 0.24 % ToothpastePSN44e94663-895b-67da-e063-6394a90a5fe62
1038929potassium nitrate 0.05 MG/MG / sodium fluoride 0.0024 MG/MG ToothpasteSCD44e94663-895b-67da-e063-6394a90a5fe62
1038929K+ nitrate 0.05 MG/MG / Sodium Fluoride 0.0024 MG/MG ToothpasteSY44e94663-895b-67da-e063-6394a90a5fe62
1038929Pot nitrate 0.05 MG/MG / Sodium Fluoride 0.0024 MG/MG ToothpasteSY44e94663-895b-67da-e063-6394a90a5fe62
1038929potassium nitrate 5 % / sodium fluoride 0.24 % (fluoride ion 0.14 % ) ToothpasteSY44e94663-895b-67da-e063-6394a90a5fe62
1038929potassium nitrate 5 % / sodium fluoride 0.24 % (fluoride ion 0.15 % ) ToothpasteSY44e94663-895b-67da-e063-6394a90a5fe62
1038929potassium nitrate 5 % / sodium fluoride 0.24 % ToothpasteSY44e94663-895b-67da-e063-6394a90a5fe62

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51206-315-01512060315011 TUBE in 1 CARTON (51206-315-01) / 133 g in 1 TUBE1 tube2025-10-082030-12-31NoNoHistorical
51206-315-025120603150212 CARTON in 1 PACKAGE, COMBINATION (51206-315-02) / 1 TUBE in 1 CARTON / 133 g in 1 TUBE12 carton2025-10-082030-12-31NoNoHistorical
51206-315-03512060315031 TUBE in 1 CARTON (51206-315-03) / 28 g in 1 TUBE1 tube2025-10-082030-12-31NoNoHistorical
51206-315-045120603150424 CARTON in 1 PACKAGE, COMBINATION (51206-315-04) / 1 TUBE in 1 CARTON / 28 g in 1 TUBE24 carton2025-10-082030-12-31NoNoHistorical
51206-315-055120603150548 CARTON in 1 PACKAGE, COMBINATION (51206-315-05) / 1 TUBE in 1 CARTON / 28 g in 1 TUBE48 carton2025-10-082030-12-31NoNoHistorical