FDA.reportPublic FDA data

Euthymol Whitening

Product NDC
53208-566
Requested package NDC
53208-566-65
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

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 1 of 52 · 1,024 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BIO SPECTRA ATTITUDESODIUM FLUORIDE9055-7588 Qubec Inc. DBA Attitude54bd43c9-489d-4e6b-9031-90ec0e3c45162026-09-01WarningsExact identifier
application number: M021
BIO SPECTRA ATTITUDESODIUM FLUORIDE9055-7588 Qubec Inc. DBA Attitude53c344e9-49f5-48aa-8309-1e15f80b80a02026-09-01WarningsExact identifier
application number: M021
COLGATE OPTIC WHITE CHARCOALSODIUM FLUORIDEColgate-Palmolive Company70ed4a93-b68f-4198-b4b7-7cfeb17ba5d22026-07-30WarningsExact identifier
application number: M021
Colgate Optic White CharcoalSODIUM FLUORIDEColgate-Palmolive Company82ac5b9d-19e8-46ac-a195-c7d85f2967d52026-07-30WarningsExact identifier
application number: M021
Supersmile Professional Whitening TP Peppy Mint 1.4 ozSODIUM MONOFLUOROPHOSPHATERobell Research, Inc251264ea-20d2-be19-e063-6394a90aa5f62026-07-29WarningsExact identifier
application number: M021
Natural White Sensitive Enamel Guard Alpine MintSODIUM FLUORIDELornamead Products2e832204-ba2d-6dcb-e063-6394a90a5e6c2026-07-29WarningsExact identifier
application number: M021
Natural White Radiant WhiteFLUORIDELornamead Productsf0b62aaa-4983-4bd3-931e-f1a31b870f622026-07-29WarningsExact identifier
application number: M021
TP OW Pro Series Stain PreventionSODIUM MONOFLUOROPHOSPHATEColgate-Palmolive Company76df52a3-b24c-4009-8137-fe644dabebf62026-07-29WarningsExact identifier
application number: M021
Colgate Kids Cavity ProtectionSODIUM FLUORIDEColgate-Palmolive Companyf0e68196-8566-443b-9cc8-b57d5c0015582026-07-29WarningsExact identifier
application number: M021
TP OW Pro Series Vividly FreshSODIUM MONOFLUOROPHOSPHATEColgate-Palmolive Companyf0551acf-c4d6-4d49-ae9c-4aeaeb99a7002026-07-29WarningsExact identifier
application number: M021
Colgate MaxFresh with Whitening KnockOut FluorideSODIUM FLUORIDEColgate-Palmolive Company92079d13-3b66-42b7-9990-2727a489b6f62026-07-28WarningsExact identifier
application number: M021
BIO SPECTRA ATTITUDESODIUM FLUORIDE9055-7588 Quebec Inc. DBA Attitude7d04d050-b283-4fce-b1e9-e695b70363f92026-07-27WarningsExact identifier
application number: M021
COLGATE OPTIC WHITE ADVANCED OXYGENATING WHITESODIUM MONOFLUOROPHOSPHATEColgate-Palmolive Companycd805999-86e4-4f6c-9889-fa9a2227d5262026-07-24WarningsExact identifier
application number: M021
COLGATE Baking Soda and Peroxide Whitening Brisk MintSODIUM MONOFLUOROPHOSPHATEColgate-Palmolive Company913a2cd6-b6a8-4069-979f-3c696a9bfdf02026-07-24WarningsExact identifier
application number: M021
COLGATE OPTIC WHITE PURPLESODIUM FLUORIDEColgate-Palmolive Company16e9b303-fc2a-451a-adc7-dcb10fc0e6f82026-07-23WarningsExact identifier
application number: M021
Orajel Kids SupermanANTICAVITY TOOTHPASTEChurch & Dwight Co., Inc.2b47af33-32d4-7c06-e063-6394a90a2f332026-07-23WarningsExact identifier
application number: M021
Sensitive Teeth and GumsPOTASSIUM NITRATE, SODIUM FLUORIDEChurch & Dwight Co., Inc.935172db-d78f-0c69-e053-2a95a90a0b692026-07-23WarningsExact identifier
application number: M021
Essentials Whiten and StrengthenSODIUM FLUORIDE 0.24%Church & Dwight Co., Inc.96548550-2cd1-b757-e053-2995a90a15ea2026-07-23WarningsExact identifier
application number: M021
TP COL OW PurpleSODIUM FLUORIDEColgate-Palmolive Companyea0db59f-f9c0-49a8-9717-69cdf071f6e12026-07-23WarningsExact identifier
application number: M021
Colgate Max Fresh Cool MintSODIUM FLUORIDEColgate-Palmolive Company00652bb2-090c-4eaa-8fc2-e0be6913a7242026-07-22WarningsExact 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
53208-566-65532080566651 TUBE in 1 CARTON (53208-566-65) / 106 g in 1 TUBE (53208-566-63) 1 tube2025-04-07NoNoCurrent