FDA.reportPublic FDA data

Opalescence Whitening

Product NDC
51206-314
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 49 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Murchison Hume Dental KitSODIUM MONOFLUOROPHOSPHATEBuzz Products Inc.b1a442e1-86cf-cba6-e053-2995a90a593a2023-12-20WarningsExact identifier
application number: M021
United Airlines Polaris Kit with ColgateSODIUM MONOFLUOROPHOSPHATEBuzz Export Services Pty Ltd (Buzz Products)de4564a4-1012-baad-e053-2a95a90a11b72023-12-20WarningsExact identifier
application number: M021
Orajel Complete ProtectionSODIUM FLUORIDEChurch & Dwight Co., Inc.daebd16f-d278-446d-8b7a-33add5a74fdd2023-12-19WarningsExact identifier
application number: M021
Orajel Sensitivity ReliefSODIUM FLUORIDE AND POTASSIUM NITRATEChurch & Dwight Co., Inc.7b9d9e7d-3844-4d18-ab03-bd0e9dcfccdb2023-12-19WarningsExact identifier
application number: M021
ORTHO GUARDSODIUM FLUORIDEMassco Dental A Division of Dunagin Pharmaceuticals8d3e0dd0-b584-413b-adf3-5c2d05ab72dd2023-12-17WarningsExact identifier
application number: M021
Beyond Activated Coconut Charcoal and Sea SaltSODIUM FLUORIDEBeyond International Incd075fa15-7309-0c10-e053-2995a90a7c952023-11-28WarningsExact identifier
application number: M021
Pro-Den RxSTANNOUS FLUORIDEDen-mat Holdings, Llc9036aa8a-59b1-41b0-b3cb-529d3303a1c02023-11-20WarningsExact identifier
application number: M021
FluoridexSTANNOUS FLUORIDE RINSEDEN-MAT HOLDINGS, LLC5e81f073-c0ca-aa38-e053-2a91aa0ab37b2023-11-20WarningsExact identifier
application number: M021
Hello Vitamin C WhiteningSODIUM FLUORIDEColgate-Palmolive Company38a0276e-910c-527d-1736-65928b9d4ca42023-11-20WarningsExact identifier
application number: M021
POP Feeling PeachySODIUM FLUORIDELG H&H CO., LTD.0abaf99b-9547-46ae-e063-6394a90a6c152023-11-17WarningsExact identifier
application number: M021
UNIVERSAL ANTI-CAVITY FLUORIDESODIUM MONOFLUOROPHOSPHATEUniversal Distribution Center LLCe3356374-befa-41b0-ab0f-edfd5a0626012023-11-16WarningsExact identifier
application number: M021
ANTI CAVITY FLUORIDESODIUM MONOFLUOROPHOSPHATEUniversal Distribution Center LLC421fc2f0-b118-4e7a-a399-ba4780028c542023-11-16WarningsExact identifier
application number: M021
UNIVERSAL CHARCOAL WITH ALOE VERA ANTI-CAVITY FLUORIDESODIUM FLUORIDEUniversal Distribution Center LLC3411924d-1002-460c-83e8-c0c7fbff9ad12023-11-16WarningsExact identifier
application number: M021
ADVANCED WHITENING ANTI CAVITY FLUORIDESODIUM MONOFLUOROPHOSPHATEUniversal Distribution Center LLC8ea8a8d9-b7e4-468f-9a09-4ec634cbd80e2023-11-16WarningsExact identifier
application number: M021
UNIVERSAL ADVANCED WHITENING ANTI-CAVITY FLUORIDESODIUM MONOFLUOROPHOSPHATEUniversal Distribution Center LLC879dfaf0-27c8-41a3-8d01-a1c3eec9edfc2023-11-15WarningsExact identifier
application number: M021
EUTHYMOL Extraordinary Pink WhiteningSODIUM FLUORIDELG H&H CO., LTD.0989936c-237d-dc63-e063-6294a90a885f2023-11-07WarningsExact identifier
application number: M021
Eurofresh WhiteningSODIUM FLUORIDEFarmasi US LLCb56b2b55-e3a4-785a-e053-2a95a90a7abf2023-11-05WarningsExact identifier
application number: M021
Farmasi WhiteningSODIUM FLUORIDEFarmasi US LLC25b3608e-abed-41ca-9971-21981b8a46102023-11-05WarningsExact identifier
application number: M021
United Airlines Therabody UPP KitSODIUM MONOFLUOROPHOSPHATEWessco Internationalfb6c355b-a67d-c4b4-e053-6394a90a0e662023-10-26WarningsExact identifier
application number: M021
United Dental KitSODIUM MONOFLUOROPHOSPHATEWessco International7f348fe7-9918-4934-bed0-f0a77c09d0462023-10-26WarningsExact 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
51206-314-025120603140212 CARTON in 1 PACKAGE, COMBINATION (51206-314-02) / 1 TUBE in 1 CARTON / 133 g in 1 TUBE12 carton2025-09-232031-01-30NoNoHistorical
51206-314-03512060314031 TUBE in 1 CARTON (51206-314-03) / 28 g in 1 TUBE1 tube2025-09-232030-11-30NoNoHistorical
51206-314-045120603140424 CARTON in 1 PACKAGE, COMBINATION (51206-314-04) / 1 TUBE in 1 CARTON / 28 g in 1 TUBE24 carton2025-09-232030-11-30NoNoHistorical
51206-314-055120603140548 CARTON in 1 PACKAGE, COMBINATION (51206-314-05) / 1 TUBE in 1 CARTON / 28 g in 1 TUBE48 carton2025-09-232030-10-31NoNoHistorical