FDA.reportPublic FDA data

Opal by Opalescence Original

Product NDC
51206-312
11-digit product format
512060312
Labeler code
51206
Product ID
51206-312_37cbe83e-8ca1-40c6-e063-6394a90a1886
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
2023-11-19
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
Opal by Opalescence Original
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
51206-312-022024-01-30C16284748780-11030e365-4aaa-111a-e063-dadaa90a10e2Opal™ by Opalescence ® Original

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51206-312-01Opal by Opalescence Original1 in 1 CARTONGEL, DENTIFRICE15
51206-312-01Opal by Opalescence Original133 g in 1 TUBEGEL, DENTIFRICE1335
51206-312-02Opal by Opalescence Original1 in 1 CARTONGEL, DENTIFRICE15
51206-312-02Opal by Opalescence Original3 in 1 PACKAGE, COMBINATIONGEL, DENTIFRICE35

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51206-312OPAL BY OPALESCENCE ORIGINAL (SODIUM FLUORIDE) GEL, DENTIFRICE [ULTRADENT PRODUCTS, INC.]4Current NDC, 4 package rows20250402_5c3bf8fc-2e8f-4a58-bcbf-e47540072a49.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1044547sodium fluoride 0.25 % ToothpastePSN5c3bf8fc-2e8f-4a58-bcbf-e47540072a495
1044547sodium fluoride 0.0025 MG/MG ToothpasteSCD5c3bf8fc-2e8f-4a58-bcbf-e47540072a495
1044547sodium fluoride 0.25 % (fluoride ion 0.15 % ) ToothpasteSY5c3bf8fc-2e8f-4a58-bcbf-e47540072a495
1044547sodium fluoride 0.25 % ToothpasteSY5c3bf8fc-2e8f-4a58-bcbf-e47540072a495

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51206-312-01512060312011 TUBE in 1 CARTON (51206-312-01) / 133 g in 1 TUBE1 tube2023-11-192029-02-21NoNoHistorical
51206-312-02512060312023 CARTON in 1 PACKAGE, COMBINATION (51206-312-02) / 1 TUBE in 1 CARTON / 133 g in 1 TUBE3 carton2023-11-192029-02-21NoNoHistorical