FDA.reportPublic FDA data

Opalescence Whitening

Product NDC
51206-314
Requested package NDC
51206-314-01
11-digit product format
512060314
Labeler code
51206
Product ID
51206-314_5b14bdd2-2852-1c00-e063-6294a90ac4cc
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
2025-09-23
Marketing end
2031-01-31
Substance
SODIUM FLUORIDE
Active strength
1.1 mg/g
NDC exclude flag
No
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
Opalescence Whitening
Brand name suffix
Cool Mint

Active Ingredients#

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

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
8ZYQ1474W7Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
416783Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
44e7d0ed-3c37-5889-e063-6294a90afccaAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51206-314-01Opalescence WhiteningCool Mint133 g in 1 TUBEGEL, DENTIFRICE1333
51206-314-01Opalescence WhiteningCool Mint1 in 1 CARTONGEL, DENTIFRICE13
51206-314-02Opalescence WhiteningCool Mint12 in 1 PACKAGE, COMBINATIONGEL, DENTIFRICE123
51206-314-02Opalescence WhiteningCool Mint1 in 1 CARTONGEL, DENTIFRICE13
51206-314-03Opalescence WhiteningCool Mint1 in 1 CARTONGEL, DENTIFRICE13
51206-314-03Opalescence WhiteningCool Mint28 g in 1 TUBEGEL, DENTIFRICE283
51206-314-04Opalescence WhiteningCool Mint1 in 1 CARTONGEL, DENTIFRICE13
51206-314-04Opalescence WhiteningCool Mint24 in 1 PACKAGE, COMBINATIONGEL, DENTIFRICE243
51206-314-05Opalescence WhiteningCool Mint48 in 1 PACKAGE, COMBINATIONGEL, DENTIFRICE483
51206-314-05Opalescence WhiteningCool Mint1 in 1 CARTONGEL, DENTIFRICE13

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 37 of 49 · 974 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dentalclean Green Diamond Alcohol Free MouthwashSODIUM FLUORIDE 0.05%Rabbit Indstria e Comrcio de Produtos de Higiene Pessoal Ltda5653aa33-4f0e-46b2-9be0-6219143556ec2025-07-14WarningsExact identifier
application number: M021
Colgate Total Gum Protect Fresh MintSTANNOUS FLUORIDECOLGATE PALMOLIVE COMPANY570e3bd6-eede-4270-9d78-055aeb2b8c172025-07-14WarningsExact identifier
application number: M021
OraPro Fluoride AnticavityFLUORIDE TOOTHPASTEProtegera, Inc.93b0181c-e29f-42f4-80f5-366463b68f092025-07-10WarningsExact identifier
application number: M021
Enamur Fluoride AntiCavity ToothpastFLUORIDE TOOTHPASTProtegera, Inc557ced45-f54e-43d8-aa13-46f75b79367c2025-07-10WarningsExact identifier
application number: M021
Super StrawberrySTRAWBERRY TOOTHPASTESuperMouth, LLC.a8c2b68d-d28b-41c0-a383-cc706b25aa1a2025-07-05WarningsExact identifier
application number: M021
Super MintSUPER MINT TOOTHPASTESuperMouth, LLC.be0915f3-36c4-4200-9d15-704cfbd632b42025-07-05WarningsExact identifier
application number: M021
Super VanillaVANILLA TOOTHPASTESuperMouth, LLC.3ddfe20a-86f1-4566-bb77-82c9749411f62025-07-05WarningsExact identifier
application number: M021
Super ChocolateCHOCOLATE TOOTHPASTESuperMouth, LLC.48607622-7c5e-4ddc-8d83-707f26c0553f2025-07-05WarningsExact identifier
application number: M021
CURODONT REPAIR FLUORIDE PLUSSODIUM FLUORIDECREDENTIS AG290c57b0-a562-0a51-e063-6294a90a07202025-06-23WarningsExact identifier
application number: M021
KarlnHans Fresh Breath Jasmine MintSODIUM MONOFLUOROPHOSPHATEPIGEON CORPORATION384863bd-b2cb-a46d-e063-6394a90a3ce22025-06-23WarningsExact identifier
application number: M021
KarlnHans Fresh Breath Double MintSODIUM MONOFLUOROPHOSPHATEPIGEON CORPORATION38487130-9508-a2c4-e063-6394a90aa3232025-06-23WarningsExact identifier
application number: M021
Crest Kids SparkleFun BubblegumSODIUM FLUORIDEProcter & Gamble Manufactura, S. de R.L. de C.V.01f0e81a-03bf-e17f-e063-6394a90a73582025-06-12WarningsExact identifier
application number: M021
Freshen UpSODIUM FLUORIDE, POTASSIUM NITRATEMKJ BRANDS LLC2ee626d1-6150-87db-e063-6294a90a64d82025-06-12WarningsExact identifier
application number: M021
Colgate MaxFresh Citrus FreshSODIUM FLUORIDEColgate-Palmolive Company13a74642-51d2-493c-ae97-a54508546a742025-06-12WarningsExact identifier
application number: M021
Colgate MaxFresh Watermelon BlastSODIUM FLUORIDEColgate-Palmolive Company4f07f945-6594-40f4-bc19-6acc12c37cdd2025-06-12WarningsExact identifier
application number: M021
Euthymol WhiteningSODIUM FLUORIDELG HOUSEHOLD & HEALTH CARE LTD.36994628-e5f3-3c35-e063-6294a90a609d2025-06-02WarningsExact identifier
application number: M021
EUTHYMOL WHITENING SPECIAL GIFT SETSODIUM FLUORIDELG HOUSEHOLD & HEALTH CARE LTD.35bfa3fc-106e-aecc-e063-6294a90a7eb02025-05-22WarningsExact identifier
application number: M021
EUTHYMOL WHITENING GIFT SET (40gX3)SODIUM FLUORIDELG HOUSEHOLD & HEALTH CARE LTD.369aa02f-c312-6a0d-e063-6294a90adaa52025-05-22WarningsExact identifier
application number: M021
EUTHYMOL WHITENING TRAVELSODIUM FLUORIDELG HOUSEHOLD & HEALTH CARE LTD.3596306e-858c-9bf7-e063-6294a90ac1d62025-05-20WarningsExact identifier
application number: M021
Euthymol WhiteningSODIUM FLUORIDELG HOUSEHOLD & HEALTH CARE LTD.3582cc91-8c32-9f93-e063-6394a90a87922025-05-19WarningsExact identifier
application number: M021

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
416783sodium fluoride 0.24 % ToothpastePSN44e7d0ed-3c37-5889-e063-6294a90afcca3
416783sodium fluoride 0.0024 MG/MG ToothpasteSCD44e7d0ed-3c37-5889-e063-6294a90afcca3
416783sodium fluoride 0.24 % (fluoride ion 0.13 % ) ToothpasteSY44e7d0ed-3c37-5889-e063-6294a90afcca3
416783sodium fluoride 0.24 % (fluoride ion 0.14 % ) ToothpasteSY44e7d0ed-3c37-5889-e063-6294a90afcca3
416783sodium fluoride 0.24 % (fluoride ion 0.15 % ) ToothpasteSY44e7d0ed-3c37-5889-e063-6294a90afcca3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51206-314-01512060314011 TUBE in 1 CARTON (51206-314-01) / 133 g in 1 TUBE1 tube2025-09-232031-01-31NoNoHistorical