FDA.reportPublic FDA data

Opal by Opalescence Sensitivity

Product NDC
51206-311
11-digit product format
512060311
Labeler code
51206
Product ID
51206-311_37cb8c52-923b-ff47-e063-6294a90ab925
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
2023-11-19
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
Opal by Opalescence Sensitivity
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
51206-311-012024-01-30C16284748780-11030e365-63b5-111a-e063-dadaa90a10e2Opal™ by Opalescence ® Sensitivity
51206-311-022024-01-30C16284748780-11030e365-63b5-111a-e063-dadaa90a10e2Opal™ by Opalescence ® Sensitivity

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51206-311-01Opal by Opalescence Sensitivity1 in 1 CARTONGEL, DENTIFRICE15
51206-311-01Opal by Opalescence Sensitivity133 g in 1 TUBEGEL, DENTIFRICE1335
51206-311-02Opal by Opalescence Sensitivity1 in 1 CARTONGEL, DENTIFRICE15
51206-311-02Opal by Opalescence Sensitivity3 in 1 PACKAGE, COMBINATIONGEL, DENTIFRICE35

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51206-311OPAL BY OPALESCENCE SENSITIVITY (POTASSIUM NITRATE AND SODIUM FLUORIDE) GEL, DENTIFRICE [ULTRADENT PRODUCTS, INC.]4Current NDC, 4 package rows20250402_5ffc0d14-0290-47bb-90e5-90a25a5acc28.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1086243potassium nitrate 5 % / sodium fluoride 0.25 % ToothpastePSN5ffc0d14-0290-47bb-90e5-90a25a5acc285
1086243potassium nitrate 0.05 MG/MG / sodium fluoride 0.0025 MG/MG ToothpasteSCD5ffc0d14-0290-47bb-90e5-90a25a5acc285
1086243K+ nitrate 0.05 MG/MG / Sodium Fluoride 0.0025 MG/MG ToothpasteSY5ffc0d14-0290-47bb-90e5-90a25a5acc285
1086243Pot nitrate 0.05 MG/MG / Sodium Fluoride 0.0025 MG/MG ToothpasteSY5ffc0d14-0290-47bb-90e5-90a25a5acc285

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51206-311-01512060311011 TUBE in 1 CARTON (51206-311-01) / 133 g in 1 TUBE1 tube2023-11-192029-10-15NoNoHistorical
51206-311-02512060311023 CARTON in 1 PACKAGE, COMBINATION (51206-311-02) / 1 TUBE in 1 CARTON / 133 g in 1 TUBE3 carton2023-11-192029-10-15NoNoHistorical