FDA.reportPublic FDA data

Opal by Opalescence Complete

Product NDC
51206-313
11-digit product format
512060313
Labeler code
51206
Product ID
51206-313_37cb56fb-2de8-0628-e063-6394a90a1b56
Type
HUMAN OTC DRUG
Nonproprietary name
Opal by Opalescence Complete
Dosage form
GEL, DENTIFRICE
Route
DENTAL
Labeler
Ultradent Products, Inc.
Application
M021
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-10-21
Substance
STANNOUS 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 Complete
Listing expiration
2026-12-31

Active Ingredients#

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

Harmonized Identifiers#

Field, Values table
FieldValues
Unii3FTR44B32Q
Rxcui416784

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51206-313-01Opal by Opalescence Complete1 in 1 CARTONGEL, DENTIFRICE13
51206-313-01Opal by Opalescence Complete133 g in 1 TUBEGEL, DENTIFRICE1333
51206-313-02Opal by Opalescence Complete1 in 1 CARTONGEL, DENTIFRICE13
51206-313-02Opal by Opalescence Complete12 in 1 PACKAGE, COMBINATIONGEL, DENTIFRICE123

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51206-313OPAL BY OPALESCENCE COMPLETE GEL, DENTIFRICE [ULTRADENT PRODUCTS, INC.]2Current NDC, 4 package rows20241208_249cc46a-dad6-0345-e063-6394a90a4447.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
416784stannous fluoride 0.454 % (fluoride ion 0.16 % ) ToothpastePSN249cc46a-dad6-0345-e063-6394a90a44473
416784stannous fluoride 0.00454 MG/MG ToothpasteSCD249cc46a-dad6-0345-e063-6394a90a44473
416784stannous fluoride 0.454 % (fluoride ion 0.14 % ) ToothpasteSY249cc46a-dad6-0345-e063-6394a90a44473
416784stannous fluoride 0.454 % (fluoride ion 0.15 % ) ToothpasteSY249cc46a-dad6-0345-e063-6394a90a44473
416784stannous fluoride 0.454 % (fluoride ion 0.16 % ) ToothpasteSY249cc46a-dad6-0345-e063-6394a90a44473

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51206-313-01512060313011 TUBE in 1 CARTON (51206-313-01) / 133 g in 1 TUBE1 tube2024-10-212027-08-14NoNoHistorical
51206-313-025120603130212 CARTON in 1 PACKAGE, COMBINATION (51206-313-02) / 1 TUBE in 1 CARTON / 133 g in 1 TUBE12 carton2024-10-212027-08-14NoNoHistorical