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 13 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CloSYSSODIUM FLUORIDERowpar Pharmaceuticals, Inc.ed617c7a-805c-4788-9bce-9b7fead4312d2026-03-31WarningsExact identifier
application number: M021
Colgate Total Enamel StrengthSTANNOUS FLUORIDEColgate-Palmolive Company1f29c893-e7c5-4a0e-941b-c2634d8211472026-03-25WarningsExact identifier
application number: M021
AP-24 WhiteningSODIUM MONOFLUOROPHOSPHATENSE Products, Inc.57e9e68c-41dd-470b-80db-dfaedc0e2a0a2026-03-24WarningsExact identifier
application number: M021
Euthymol WhiteningSODIUM FLUORIDELG HOUSEHOLD & HEALTH CARE LTD.369c0d44-6375-dcae-e063-6394a90a74d02026-03-24WarningsExact identifier
application number: M021
ndc (product): 53208-566
Euthymol Whitening Purple CorrectorSODIUM FLUORIDELG HOUSEHOLD & HEALTH CARE LTD.369bc785-fb77-a56d-e063-6394a90a2e6b2026-03-24WarningsExact identifier
application number: M021
SensitiveToothpasteANTI SENSITIVETOOTHPASTEHuain Best Trade Co., Ltd.4db239f3-2ad7-3a5b-e063-6294a90a11a72026-03-23WarningsExact identifier
application number: M021
Crest BubblegumSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company7d6268c7-b273-1bbf-e053-2a91aa0a5d322026-03-17WarningsExact identifier
application number: M021
Natures Promise Childrens Fluoride StrawberrySODIUM MONOFLUOROPHOSPHATEFoodhold U.S.A.81a4e196-8b2d-0745-e053-2991aa0a7de62026-03-16WarningsExact identifier
application number: M021
Stance0.63% STANNOUS FLUORIDE CONCENTRATE RINSEElevate Oral Care3ae8badf-f960-62fd-e054-00144ff8d46c2026-03-11WarningsExact identifier
application number: M021
Stance0.63% STANNOUS FLUORIDE CONCENTRATE RINSEElevate Oral Care3ae71258-a8c2-6eb5-e054-00144ff88e882026-03-11WarningsExact identifier
application number: M021
Delta Travel Kit Comfort plusSODIUM MONOFLUOROPHOSPHATEBuzz Products Inc.d31e0920-4317-1e0c-e053-2a95a90aebeb2026-03-11WarningsExact identifier
application number: M021
Anticavity Fluoride RinseSODIUM FLUORIDECVS Pharmacy, Inc.eac346d9-d9c1-4417-8193-390c7a0dcc2a2026-03-10Warnings, Adverse reactionsExact identifier
application number: M021
Crest Cavity Protection RegularSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company6caf3f2e-70a2-4530-99fa-f5af7e4c511a2026-03-10WarningsExact identifier
application number: M021
Amerfresh ToothpowderSODIUM FLUORIDEYangzhou ONE & ONLY Personal Care Products Co., LTD1cacf93e-aa60-4717-87ab-0568a701a4f32026-03-10WarningsExact identifier
application number: M021
AnticavitySODIUM FLUORIDECVS Pharmacy, Inc.a51357df-6d55-4030-a5db-42da7ba54a372026-03-09Warnings, Adverse reactionsExact identifier
application number: M021
FluorideFLUORIDE TOOTHPASTEMcKesson4c482e45-0502-a93a-e063-6394a90aa9612026-03-05WarningsExact identifier
application number: M021
Colgate Maximum Cavity Protection Bubble Fruit FlavorSODIUM FLUORIDEColgate-Palmolive Company0a1389f6-cac9-3d58-0744-c488abb0bbcc2026-03-03WarningsExact identifier
application number: M021
Alcohol-Free AnticavitySODIUM FLUORIDEAmazon.com Services LLC349eca80-2e0c-409b-af29-3235fdc0695b2026-03-03Warnings, Adverse reactionsExact identifier
application number: M021
Oral AntivavitySODIUM FLUORIDEAmazon.com Services LLC03735abc-d1be-4ca0-a497-0a5c5f2894022026-03-03Warnings, Adverse reactionsExact identifier
application number: M021
AnticavitySODIUM FLUORIDEOld East Main Co.f8036e2e-7541-4922-92b9-0d8319f7b64c2026-03-02Warnings, Adverse reactionsExact 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