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 6 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Freshen Up chai latte mintSODIUM FLUORIDEMKJ BRANDS LLC52e364f9-113a-df4e-e063-6294a90a263b2026-07-14WarningsExact identifier
application number: M021
Freshen Up Holiday mintSODIUM FLUORIDEMKJ BRANDS LLC5257c409-d379-8c48-e063-6294a90acda92026-07-14WarningsExact identifier
application number: M021
Freshen-up Matcha MintSODIUM FLUORIDEMKJ BRANDS LLC52bbc6d9-17ab-851a-e063-6394a90ab4bf2026-07-14WarningsExact identifier
application number: M021
Freshen Up pepper mintSODIUM FLUORIDEMKJ BRANDS LLC5259bc45-85da-b17b-e063-6294a90a79192026-07-14WarningsExact identifier
application number: M021
Colgate Optic White Advanced Icy FreshSODIUM MONOFLUOROPHOSPHATEColgate-Palmolive Companyf95496e3-11ec-4cd6-b3ee-cf6c657b790b2026-07-13WarningsExact identifier
application number: M021
COLGATE MAX FRESH COCONUT PINEAPPLESODIUM FLUORIDEColgate-Palmolive Company7f240d1d-ea3d-42b1-a4b0-106c587074522026-07-08WarningsExact identifier
application number: M021
Crest 3D White Deep Stain Remover Ultra WhiteSODIUM MONOFLUOROPHOSPHATEThe Procter & Gamble Manufacturing Company2f24a9eb-7a89-30e1-e063-6394a90a032b2026-07-08Exact identifier
application number: M021
Dr. Noah Kids ToothSODIUM MONOFLUOROPHOSPHATEProject Noah Inc.562311aa-9ac5-00c2-e063-6394a90a67a72026-07-08WarningsExact identifier
application number: M021
COLGATE BAKING SODA AND PEROXIDE WHITENING OXYGEN BUBBLES FROSTY MINTSODIUM MONOFLUOROPHOSPHATEColgate-Palmolive Company263fef13-347b-489b-987d-933a63dbc9002026-07-08WarningsExact identifier
application number: M021
Colgate Triple ActionSODIUM FLUORIDEColgate-Palmolive Company3082e9ba-66d9-4fc7-bbe6-b41b60939bd22026-07-08WarningsExact identifier
application number: M021
Colgate Junior Kids Batman Mild Bubble Fruit FluorideSODIUM FLUORIDEColgate-Palmolive Companyf464cecb-e876-4057-ab5c-94de747434db2026-07-08WarningsExact identifier
application number: M021
Crest Premium Plus Scope Active Foam plus Whitening Minty FreshSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company560815d6-018a-0c24-e063-6394a90a10712026-07-07WarningsExact identifier
application number: M021
Crest Plus Scope plus Whitening with MouthwashSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company54ecfbed-ba99-11eb-e063-6294a90ae64d2026-07-07WarningsExact identifier
application number: M021
Crest Plus Scope plus Whitening Minty Fresh with Mouthwash stripedSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company56091601-74dd-0a3b-e063-6394a90af4762026-07-07WarningsExact identifier
application number: M021
Crest Plus Scope plus Whitening Outlast MintSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company55054217-f21b-1c41-e063-6394a90ae40b2026-07-07WarningsExact identifier
application number: M021
Hello Dragon Dazzle Dragon Dazzle FluorideSODIUM FLUORIDEColgate-Palmolive Companyeaca1ad1-9e31-b904-4148-247ad24606612026-07-07WarningsExact identifier
application number: M021
Colgate Cavity ProtectionSODIUM FLUORIDEColgate-Palmolive Companycdd2ad04-8c65-40f2-b323-5ce11af52e4f2026-07-06WarningsExact identifier
application number: M021
AIM Cavity Protection with WhiteningSODIUM FLUORIDEChurch & Dwight Co., Inc.a8c742e1-ee61-4593-b8f5-b9e586d39dfc2026-07-01WarningsExact identifier
application number: M021
TOMS OF MAINE ANTICAVITY FRESHMINTSODIUM FLUORIDETom's of Maine6f825520-0f8a-4b4c-bbb6-987f64ab87692026-07-01WarningsExact identifier
application number: M021
Colgate Deep Clean FluorideSODIUM FLUORIDEColgate-Palmolive Company47e8e943-f4d5-40bc-8f79-ec9ea06125de2026-07-01WarningsExact 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