FDA.reportPublic FDA data

Euthymol Whitening

Product NDC
53208-566
11-digit product format
532080566
Labeler code
53208
Product ID
53208-566_32342b24-08d3-f8e0-e063-6294a90ae39f
Type
HUMAN OTC DRUG
Nonproprietary name
Sodium Fluoride
Dosage form
PASTE, DENTIFRICE
Route
DENTAL
Labeler
LG HOUSEHOLD & HEALTH CARE LTD.
Application
M021
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-04-07
Substance
SODIUM FLUORIDE
Active strength
1.5 mg/g
NDC exclude flag
No
Listing certified through
2026-12-31
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
Euthymol Whitening
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SODIUM FLUORIDE1.5 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
891775Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
303d4ad0-5a2b-347a-e063-6394a90aa0baAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53208-566-62Euthymol Whitening2 in 1 CELLO PACKPASTE, DENTIFRICE25
53208-566-63Euthymol Whitening106 g in 1 TUBEPASTE, DENTIFRICE1065
53208-566-64Euthymol Whitening3 in 1 CELLO PACKPASTE, DENTIFRICE35
53208-566-43Euthymol Whitening40 g in 1 TUBEPASTE, DENTIFRICE404
53208-566-45Euthymol Whitening1 in 1 CARTONPASTE, DENTIFRICE14
53208-566-43EUTHYMOL WHITENING GIFT SET(40gX3)40 g in 1 TUBEPASTE, DENTIFRICE120 g in 31.5 mg in 1g3
53208-566-43EUTHYMOL WHITENING TRAVEL40 g in 1 TUBEPASTE, DENTIFRICE40 g1.5 mg in 1g3
53208-566-45EUTHYMOL WHITENING TRAVEL1 in 1 CARTONPASTE, DENTIFRICE1.5 mg in 1g3
53208-566-46EUTHYMOL WHITENING GIFT SET(40gX3)3 in 1 CARTONPASTE, DENTIFRICE1.5 mg in 1g3
53208-566-63EUTHYMOL WHITENING SPECIAL GIFT SET106 g in 1 TUBEPASTE, DENTIFRICE2 g in 2121.5 mg in 1g3
53208-566-63EUTHYMOL WHITENING SET106 g in 1 TUBEPASTE, DENTIFRICE424 g in 41.5 mg in 1g3
53208-566-65EUTHYMOL WHITENING SET4 in 1 CARTONPASTE, DENTIFRICE1.5 mg in 1g3
53208-566-65EUTHYMOL WHITENING SPECIAL GIFT SET2 in 1 CARTONPASTE, DENTIFRICE1.5 mg in 1g3
53208-566-73Euthymol Whitening70 g in 1 TUBEPASTE, DENTIFRICE703
53208-566-73EUTHYMOL WHITENING SET70 g in 1 TUBEPASTE, DENTIFRICE70 g1.5 mg in 1g3
53208-566-75EUTHYMOL WHITENING SET1 in 1 CARTONPASTE, DENTIFRICE1.5 mg in 1g3
53208-566-75Euthymol Whitening1 in 1 CARTONPASTE, DENTIFRICE13
53208-566-63Euthymol Whitening106 g in 1 TUBEPASTE, DENTIFRICE1062
53208-566-65Euthymol Whitening1 in 1 CARTONPASTE, DENTIFRICE12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53208-566EUTHYMOL WHITENING (SODIUM FLUORIDE) PASTE, DENTIFRICE [LG HOUSEHOLD & HEALTH CARE LTD.]2Current NDC, 2 package rows20250409_303d4ad0-5a2b-347a-e063-6394a90aa0ba.zip

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 11 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Colgate Total SF WhiteningSTANNOUS FLUORIDEColgate-Palmolive Company3bba340e-2a62-3b04-41b5-0ed9c13adb132026-04-22WarningsExact identifier
application number: M021
EverSmile SquirtSODIUM FLUORIDE 0.05%Everbrands, Inc.bc0ef174-2909-469a-b629-0eab4412bdfc2026-04-20WarningsExact identifier
application number: M021
Gum DetoxifySTANNOUS FLUORIDEWalmart41d6cc7a-0b87-e474-e063-6294a90ae9952026-04-20WarningsExact identifier
application number: M021
Eversmile Squirt2.65% HYDROGEN PEROXIDEEverbrands, Inc.2c43dedf-eeb0-43ba-a352-3d56ffd9d6cf2026-04-19WarningsExact identifier
application number: M021
Alcohol-Free AnticavitySODIUM FLUORIDEH E B8d40f693-083c-4eb6-9da1-42675d757e0e2026-04-16Warnings, Adverse reactionsExact identifier
application number: M021
Eversmile OrthoFoam Anticavity0.05% SODIUM FLUORIDE RINSEEverbrands, Inc.9c12e792-94c8-4e29-9a54-e7e70aadade62026-04-16WarningsExact identifier
application number: M021
Eversmile Squirt2.65% HYDROGEN PEROXIDEEverbrands, Inc.6753b426-6d49-4438-a52f-c28e60a0e9d82026-04-16WarningsExact identifier
application number: M021
Osstem G Gum Health Care ToothSODIUM FLUORIDEOsstem Pharma Co., Ltd4f8b4fc0-4c98-5e52-e063-6394a90af7102026-04-15WarningsExact identifier
application number: M021
Crest 3D White Deep Stain Remover Enamel StrengthSODIUM MONOFLUOROPHOSPHATEThe Procter & Gamble Manufacturing Company4f6b8851-c778-8abd-e063-6294a90aef4f2026-04-14Exact identifier
application number: M021
Crest 3D White Stain Eraser Luxe MintSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company4f6beb3b-2521-bfb7-e063-6394a90ad9ea2026-04-14Exact identifier
application number: M021
Kids Crest Strawberry RushSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company6d96c5bb-d8d9-fbf6-e053-2a91aa0a5d132026-04-14WarningsExact identifier
application number: M021
Crest Pro-Health Mouthwash Multi-Protection Strong MintSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company4f6d11b2-5aa2-ab34-e063-6294a90ac0bc2026-04-14WarningsExact identifier
application number: M021
Anticavity Fluoride RinseSODIUM FLUORIDEPublix Super Markets, Inc.cb6850e9-ba3e-47ac-a3ca-5de4d57c01cb2026-04-14Warnings, Adverse reactionsExact identifier
application number: M021
AnticavitySODIUM FLUORIDEPublix Super Markets, Inc.f0e84078-499f-4a5a-bcd2-23f57805de862026-04-14Warnings, Adverse reactionsExact identifier
application number: M021
Crest Pro-Health Advanced Multi-ProtectionSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company1cfc5b61-c8e5-943d-e063-6394a90a890b2026-04-14WarningsExact identifier
application number: M021
Crest Pro-Health Multi-Protection plus Extra WhiteningSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company4f6f6299-f95f-2f0e-e063-6294a90a16412026-04-14WarningsExact identifier
application number: M021
Crest 3D White Strength Whitening Enamel ProtectionSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company4f7125aa-3aa2-ca64-e063-6394a90a4cf32026-04-14WarningsExact identifier
application number: M021
Eversmile TheraFoam0.05% SODIUM FLUORIDE RINSEEverbrands, Inc.57da2479-923a-45ec-8149-57b469b116372026-04-13WarningsExact identifier
application number: M021
Crest Pro-Health Advanced Bacteria ProtectionSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Company4f1ce508-fe6e-4045-e063-6294a90ab3e22026-04-10WarningsExact identifier
application number: M021
Crest Pro-Health Sensitivity ReliefSODIUM FLUORIDE AND POTASSIUM NITRATEThe Procter & Gamble Manufacturing Company4f1d62ae-653e-3046-e063-6294a90abbf82026-04-10WarningsExact identifier
application number: M021

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
891775sodium fluoride 0.243 % ToothpastePSN369c0d44-6375-dcae-e063-6394a90a74d05
891775sodium fluoride 0.00243 MG/MG ToothpasteSCD369c0d44-6375-dcae-e063-6394a90a74d05
891775sodium fluoride 0.243 % (fluoride ion 0.13 % ) ToothpasteSY369c0d44-6375-dcae-e063-6394a90a74d05
891775sodium fluoride 0.243 % (fluoride ion 0.14 % ) ToothpasteSY369c0d44-6375-dcae-e063-6394a90a74d05
891775sodium fluoride 0.243 % (fluoride ion 0.15 % ) ToothpasteSY369c0d44-6375-dcae-e063-6394a90a74d05
891775sodium fluoride 0.243 % (fluoride ion 0.16 % ) ToothpasteSY369c0d44-6375-dcae-e063-6394a90a74d05
891775sodium fluoride 0.243 % ToothpastePSN36994628-e5f3-3c35-e063-6294a90a609d4
891775sodium fluoride 0.00243 MG/MG ToothpasteSCD36994628-e5f3-3c35-e063-6294a90a609d4
891775sodium fluoride 0.243 % (fluoride ion 0.13 % ) ToothpasteSY36994628-e5f3-3c35-e063-6294a90a609d4
891775sodium fluoride 0.243 % (fluoride ion 0.14 % ) ToothpasteSY36994628-e5f3-3c35-e063-6294a90a609d4
891775sodium fluoride 0.243 % (fluoride ion 0.15 % ) ToothpasteSY36994628-e5f3-3c35-e063-6294a90a609d4
891775sodium fluoride 0.243 % (fluoride ion 0.16 % ) ToothpasteSY36994628-e5f3-3c35-e063-6294a90a609d4
891775sodium fluoride 0.243 % ToothpastePSN35bfa3fc-106e-aecc-e063-6294a90a7eb03
891775sodium fluoride 0.243 % ToothpastePSN369aa02f-c312-6a0d-e063-6294a90adaa53
891775sodium fluoride 0.243 % ToothpastePSN3596306e-858c-9bf7-e063-6294a90ac1d63
891775sodium fluoride 0.243 % ToothpastePSN3582cc91-8c32-9f93-e063-6394a90a87923
891775sodium fluoride 0.243 % ToothpastePSN35839b10-4c40-40e5-e063-6294a90a85b43
891775sodium fluoride 0.00243 MG/MG ToothpasteSCD369aa02f-c312-6a0d-e063-6294a90adaa53
891775sodium fluoride 0.00243 MG/MG ToothpasteSCD3582cc91-8c32-9f93-e063-6394a90a87923
891775sodium fluoride 0.00243 MG/MG ToothpasteSCD3596306e-858c-9bf7-e063-6294a90ac1d63
891775sodium fluoride 0.00243 MG/MG ToothpasteSCD35839b10-4c40-40e5-e063-6294a90a85b43
891775sodium fluoride 0.00243 MG/MG ToothpasteSCD35bfa3fc-106e-aecc-e063-6294a90a7eb03
891775sodium fluoride 0.243 % (fluoride ion 0.13 % ) ToothpasteSY35839b10-4c40-40e5-e063-6294a90a85b43
891775sodium fluoride 0.243 % (fluoride ion 0.13 % ) ToothpasteSY369aa02f-c312-6a0d-e063-6294a90adaa53
891775sodium fluoride 0.243 % (fluoride ion 0.13 % ) ToothpasteSY3582cc91-8c32-9f93-e063-6394a90a87923
891775sodium fluoride 0.243 % (fluoride ion 0.13 % ) ToothpasteSY35bfa3fc-106e-aecc-e063-6294a90a7eb03
891775sodium fluoride 0.243 % (fluoride ion 0.13 % ) ToothpasteSY3596306e-858c-9bf7-e063-6294a90ac1d63
891775sodium fluoride 0.243 % (fluoride ion 0.14 % ) ToothpasteSY35bfa3fc-106e-aecc-e063-6294a90a7eb03
891775sodium fluoride 0.243 % (fluoride ion 0.14 % ) ToothpasteSY369aa02f-c312-6a0d-e063-6294a90adaa53
891775sodium fluoride 0.243 % (fluoride ion 0.14 % ) ToothpasteSY3582cc91-8c32-9f93-e063-6394a90a87923
891775sodium fluoride 0.243 % (fluoride ion 0.14 % ) ToothpasteSY3596306e-858c-9bf7-e063-6294a90ac1d63
891775sodium fluoride 0.243 % (fluoride ion 0.14 % ) ToothpasteSY35839b10-4c40-40e5-e063-6294a90a85b43
891775sodium fluoride 0.243 % (fluoride ion 0.15 % ) ToothpasteSY35bfa3fc-106e-aecc-e063-6294a90a7eb03
891775sodium fluoride 0.243 % (fluoride ion 0.15 % ) ToothpasteSY3582cc91-8c32-9f93-e063-6394a90a87923
891775sodium fluoride 0.243 % (fluoride ion 0.15 % ) ToothpasteSY35839b10-4c40-40e5-e063-6294a90a85b43
891775sodium fluoride 0.243 % (fluoride ion 0.15 % ) ToothpasteSY369aa02f-c312-6a0d-e063-6294a90adaa53
891775sodium fluoride 0.243 % (fluoride ion 0.15 % ) ToothpasteSY3596306e-858c-9bf7-e063-6294a90ac1d63
891775sodium fluoride 0.243 % (fluoride ion 0.16 % ) ToothpasteSY3596306e-858c-9bf7-e063-6294a90ac1d63
891775sodium fluoride 0.243 % (fluoride ion 0.16 % ) ToothpasteSY35839b10-4c40-40e5-e063-6294a90a85b43
891775sodium fluoride 0.243 % (fluoride ion 0.16 % ) ToothpasteSY369aa02f-c312-6a0d-e063-6294a90adaa53
891775sodium fluoride 0.243 % (fluoride ion 0.16 % ) ToothpasteSY3582cc91-8c32-9f93-e063-6394a90a87923
891775sodium fluoride 0.243 % (fluoride ion 0.16 % ) ToothpasteSY35bfa3fc-106e-aecc-e063-6294a90a7eb03
891775sodium fluoride 0.243 % ToothpastePSN303d4ad0-5a2b-347a-e063-6394a90aa0ba2
891775sodium fluoride 0.00243 MG/MG ToothpasteSCD303d4ad0-5a2b-347a-e063-6394a90aa0ba2
891775sodium fluoride 0.243 % (fluoride ion 0.13 % ) ToothpasteSY303d4ad0-5a2b-347a-e063-6394a90aa0ba2
891775sodium fluoride 0.243 % (fluoride ion 0.14 % ) ToothpasteSY303d4ad0-5a2b-347a-e063-6394a90aa0ba2
891775sodium fluoride 0.243 % (fluoride ion 0.15 % ) ToothpasteSY303d4ad0-5a2b-347a-e063-6394a90aa0ba2
891775sodium fluoride 0.243 % (fluoride ion 0.16 % ) ToothpasteSY303d4ad0-5a2b-347a-e063-6394a90aa0ba2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
53208-566-435320805664340 g in 1 TUBE40 gHistorical
53208-566-45532080566451 TUBE in 1 CARTON (53208-566-45) / 40 g in 1 TUBE (53208-566-43) 1 tube2025-06-02NoNoCurrent
53208-566-46532080566463 in 1 CARTONHistorical
53208-566-62532080566622 CELLO PACK in 1 CELLO PACK (53208-566-62) / 3 TUBE in 1 CELLO PACK (53208-566-64) / 106 g in 1 TUBE (53208-566-63) 2 cello pack2025-09-09NoNoCurrent
53208-566-6353208056663106 g in 1 TUBE106 gHistorical
53208-566-64532080566643 in 1 CELLO PACKHistorical
53208-566-65532080566651 TUBE in 1 CARTON (53208-566-65) / 106 g in 1 TUBE (53208-566-63) 1 tube2025-04-07NoNoCurrent
53208-566-735320805667370 g in 1 TUBE70 gHistorical
53208-566-75532080566751 TUBE in 1 CARTON (53208-566-75) / 70 g in 1 TUBE (53208-566-73) 1 tube2025-06-09NoNoCurrent