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 16 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Toms of Maine Whiten Plus Deep Clean PeppermintSODIUM FLUORIDETom's of Maine4c535776-3f80-4eeb-bb63-2d734c3c3a6b2026-02-18WarningsExact identifier
application number: M021
AnticavitySODIUM FLUORIDEUnited Natural Foods, Inc. dba UNFIdd6bf8df-1e28-4f61-b876-b9f1f8d5993a2026-02-17Warnings, Adverse reactionsExact identifier
application number: M021
AnticavitySODIUM FLUORIDEUnited Natural Foods, Inc. dba UNFI8283cea0-7b62-4796-8763-6654039664cd2026-02-17Warnings, Adverse reactionsExact identifier
application number: M021
AnticavitySODIUM FLUORIDEUnited Natural Foods, Inc. dba UNFI9d055fed-26d8-4827-a4cc-8c314514a6c32026-02-17WarningsExact identifier
application number: M021
Brush Buddies Crayola Color Changing ANTICAVITY FLUORIDE WATERMELON FLAVORSODIUM FLUORIDEAshtel Studios, Inc.28d1b8c3-930f-4ac9-aa5a-b72b832bb77e2026-02-17WarningsExact identifier
application number: M021
Anticavity RinseSODIUM FLUORIDEValu Merchandisers Company088b95e6-30fd-4263-9fdc-57cd63385b712026-02-16Warnings, Adverse reactionsExact identifier
application number: M021
Anticavity Fluoride RinseSODIUM FLUORIDEValu Merchandisers Companye31c1609-a1c3-4ed5-adfd-3cfa63205ec32026-02-16Warnings, Adverse reactionsExact identifier
application number: M021
AnticavitySODIUM FLUORIDEUnited Natural Foods, Inc. dba UNFI3602c528-5f53-4d41-bf67-163149f52b352026-02-16Warnings, Adverse reactionsExact identifier
application number: M021
Anticavity Fluoride RinseSODIUM FLUORIDEUnited Natural Foods, Inc. dba UNFIe696038c-182e-4325-9b90-87fe498d9f672026-02-16Warnings, Adverse reactionsExact identifier
application number: M021
Anticavity Fluoride RinseSODIUM FLUORIDETopco Associates LLC3b04142a-4a65-45ba-a5a2-e62b0c47ec552026-02-13Warnings, Adverse reactionsExact identifier
application number: M021
Mouth RinseSODIUM FLUORIDETopco Associates LLCc640adc0-e178-4b6a-af44-07d2f7da81d32026-02-13Warnings, Adverse reactionsExact identifier
application number: M021
Anticavity Fluoride RinseSODIUM FLUORIDETopco Associates LLCf760f8f8-0c74-4a6e-b5c9-cc82b8758a452026-02-13Warnings, Adverse reactionsExact identifier
application number: M021
Alcohol-Free AnticavitySODIUM FLUORIDETopco Associates LLCade7dcb2-b4e2-4cef-b9a7-469867ead68a2026-02-13Warnings, Adverse reactionsExact identifier
application number: M021
Oral AntivavitySODIUM FLUORIDETopco Associates LLC84b30711-a7e5-4189-895a-a7989f05591c2026-02-13Warnings, Adverse reactionsExact identifier
application number: M021
Anticavity fluoride rinseSODIUM FLUORIDETopco Associates LLCc3f2e952-a8d5-4e9d-a5c6-09e4f25441792026-02-13Warnings, Adverse reactionsExact identifier
application number: M021
AnticavitySODIUM FLUORIDETopco Associates LLCa9b8b2fe-0a60-4f65-b6f6-aae8509c919f2026-02-13Warnings, Adverse reactionsExact identifier
application number: M021
SaliveaFLUORIDE TOOTHPASTELaclede, Inc.4abb0f80-d87d-730f-e063-6294a90a15f72026-02-13WarningsExact identifier
application number: M021
AnticavitySODIUM FLUORIDEYour Military Exchanges581d5cdb-018a-42ad-899d-5331f00633762026-02-12Warnings, Adverse reactionsExact identifier
application number: M021
Alcohol-Free AnticavitySODIUM FLUORIDEYour Military Exchanges965911c3-7aa8-4830-8269-6aa5d526ee732026-02-12Warnings, Adverse reactionsExact identifier
application number: M021
Mouth RinseSODIUM FLUORIDEWalgreen Co.eae87899-3eba-4d50-bc31-9eaf54ff9e002026-02-12Warnings, Adverse reactionsExact 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