FDA.reportPublic FDA data

Opalescence Whitening

Product NDC
51206-302
11-digit product format
512060302
Labeler code
51206
Product ID
51206-302_43d0d640-82ea-c153-e063-6294a90abff1
Type
HUMAN OTC DRUG
Nonproprietary name
Sodium Fluoride
Dosage form
GEL, DENTIFRICE
Route
DENTAL
Labeler
Ultradent Products, Inc
Application
M021
Marketing category
OTC MONOGRAPH DRUG
Marketing start
1994-07-01
Substance
SODIUM FLUORIDE
Active strength
1.1 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
Opalescence Whitening
Listing expiration
2026-12-31

Active Ingredients#

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

Harmonized Identifiers#

Field, Values table
FieldValues
Unii8ZYQ1474W7
Rxcui1044547

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
51206-302-062024-01-30C16284748780-11030e365-591f-111a-e063-dadaa90a10e2Opalescence™ whitening toothpaste
51206-302-072024-01-30C16284748780-11030e365-591f-111a-e063-dadaa90a10e2Opalescence™ whitening toothpaste
51206-302-082024-01-30C16284748780-11030e365-591f-111a-e063-dadaa90a10e2Opalescence™ whitening toothpaste
51206-302-092024-01-30C16284748780-11030e365-591f-111a-e063-dadaa90a10e2Opalescence™ whitening toothpaste
51206-302-102024-01-30C16284748780-11030e365-591f-111a-e063-dadaa90a10e2Opalescence™ whitening toothpaste
51206-302-112024-01-30C16284748780-11030e365-591f-111a-e063-dadaa90a10e2Opalescence™ whitening toothpaste

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51206-302-06Opalescence Whitening133 g in 1 TUBEGEL, DENTIFRICE1339
51206-302-06Opalescence Whitening1 in 1 BOXGEL, DENTIFRICE19
51206-302-07Opalescence Whitening1 in 1 BOXGEL, DENTIFRICE19
51206-302-07Opalescence Whitening28.35 g in 1 TUBEGEL, DENTIFRICE28.359
51206-302-08Opalescence Whitening1 in 1 BOXGEL, DENTIFRICE19
51206-302-08Opalescence Whitening3 in 1 PACKAGE, COMBINATIONGEL, DENTIFRICE39
51206-302-09Opalescence Whitening1 in 1 BOXGEL, DENTIFRICE19
51206-302-09Opalescence Whitening12 in 1 PACKAGE, COMBINATIONGEL, DENTIFRICE129
51206-302-10Opalescence Whitening24 in 1 PACKAGE, COMBINATIONGEL, DENTIFRICE249
51206-302-10Opalescence Whitening1 in 1 BOXGEL, DENTIFRICE19
51206-302-11Opalescence Whitening1 in 1 BOXGEL, DENTIFRICE19
51206-302-11Opalescence Whitening6 in 1 PACKAGE, COMBINATIONGEL, DENTIFRICE69

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Sodium FluorideACTIVE INGREDIENT8ZYQ1474W7OPALESCENCE WHITENING TOOTHPASTE (SODIUM FLUORIDE) GEL, DENTIFRICE [ULTRADENT PRODUCTS, INC.]1
Fluoride IonACTIVE MOIETYQ80VPU408OOPALESCENCE WHITENING TOOTHPASTE (SODIUM FLUORIDE) GEL, DENTIFRICE [ULTRADENT PRODUCTS, INC.]1
FD&C Blue No. 1INACTIVE INGREDIENTH3R47K3TBDOPALESCENCE WHITENING TOOTHPASTE (SODIUM FLUORIDE) GEL, DENTIFRICE [ULTRADENT PRODUCTS, INC.]1
FD&C Yellow No. 5INACTIVE INGREDIENTI753WB2F1MOPALESCENCE WHITENING TOOTHPASTE (SODIUM FLUORIDE) GEL, DENTIFRICE [ULTRADENT PRODUCTS, INC.]1
GlycerinINACTIVE INGREDIENTPDC6A3C0OXOPALESCENCE WHITENING TOOTHPASTE (SODIUM FLUORIDE) GEL, DENTIFRICE [ULTRADENT PRODUCTS, INC.]1
Methyl SalicylateINACTIVE INGREDIENTLAV5U5022YOPALESCENCE WHITENING TOOTHPASTE (SODIUM FLUORIDE) GEL, DENTIFRICE [ULTRADENT PRODUCTS, INC.]1
Saccharin SodiumINACTIVE INGREDIENTSB8ZUX40TYOPALESCENCE WHITENING TOOTHPASTE (SODIUM FLUORIDE) GEL, DENTIFRICE [ULTRADENT PRODUCTS, INC.]1
Silicon DioxideINACTIVE INGREDIENTETJ7Z6XBU4OPALESCENCE WHITENING TOOTHPASTE (SODIUM FLUORIDE) GEL, DENTIFRICE [ULTRADENT PRODUCTS, INC.]1
Sodium BenzoateINACTIVE INGREDIENTOJ245FE5EUOPALESCENCE WHITENING TOOTHPASTE (SODIUM FLUORIDE) GEL, DENTIFRICE [ULTRADENT PRODUCTS, INC.]1
Sodium Lauryl SulfateINACTIVE INGREDIENT368GB5141JOPALESCENCE WHITENING TOOTHPASTE (SODIUM FLUORIDE) GEL, DENTIFRICE [ULTRADENT PRODUCTS, INC.]1
SorbitolINACTIVE INGREDIENT506T60A25ROPALESCENCE WHITENING TOOTHPASTE (SODIUM FLUORIDE) GEL, DENTIFRICE [ULTRADENT PRODUCTS, INC.]1
WaterINACTIVE INGREDIENT059QF0KO0ROPALESCENCE WHITENING TOOTHPASTE (SODIUM FLUORIDE) GEL, DENTIFRICE [ULTRADENT PRODUCTS, INC.]1
Xanthan GumINACTIVE INGREDIENTTTV12P4NEEOPALESCENCE WHITENING TOOTHPASTE (SODIUM FLUORIDE) GEL, DENTIFRICE [ULTRADENT PRODUCTS, INC.]1
XylitolINACTIVE INGREDIENTVCQ006KQ1EOPALESCENCE WHITENING TOOTHPASTE (SODIUM FLUORIDE) GEL, DENTIFRICE [ULTRADENT PRODUCTS, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51206-302OPALESCENCE WHITENING (SODIUM FLUORIDE) GEL, DENTIFRICE [ULTRADENT PRODUCTS, INC]7Current NDC, Legacy NDC, 12 package rows20240224_d07f842e-b6f1-4ae1-b576-f542ecd02dd4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1044547sodium fluoride 0.25 % ToothpastePSNd07f842e-b6f1-4ae1-b576-f542ecd02dd49
1044547sodium fluoride 0.0025 MG/MG ToothpasteSCDd07f842e-b6f1-4ae1-b576-f542ecd02dd49
1044547sodium fluoride 0.25 % (fluoride ion 0.15 % ) ToothpasteSYd07f842e-b6f1-4ae1-b576-f542ecd02dd49
1044547sodium fluoride 0.25 % ToothpasteSYd07f842e-b6f1-4ae1-b576-f542ecd02dd49

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51206-302-06512060302061 TUBE in 1 BOX (51206-302-06) / 133 g in 1 TUBE1 tube1994-07-012030-09-30NoNoCurrent
51206-302-07512060302071 TUBE in 1 BOX (51206-302-07) / 28.35 g in 1 TUBE1 tube1994-07-012030-09-30NoNoCurrent
51206-302-08512060302083 BOX in 1 PACKAGE, COMBINATION (51206-302-08) / 1 TUBE in 1 BOX / 133 g in 1 TUBE3 box2016-06-012030-09-30NoNoCurrent
51206-302-095120603020912 BOX in 1 PACKAGE, COMBINATION (51206-302-09) / 1 TUBE in 1 BOX / 133 g in 1 TUBE12 box2016-06-012030-09-30NoNoCurrent
51206-302-105120603021024 BOX in 1 PACKAGE, COMBINATION (51206-302-10) / 1 TUBE in 1 BOX / 28.35 g in 1 TUBE24 box2016-06-012030-09-03NoNoCurrent
51206-302-11512060302116 BOX in 1 PACKAGE, COMBINATION (51206-302-11) / 1 TUBE in 1 BOX / 133 g in 1 TUBE6 box2020-08-242030-09-30NoNoCurrent