FDA.reportPublic FDA data

EUTHYMOL WHITENING GIFT SET

Product NDC
53208-573
11-digit product format
532080573
Labeler code
53208
Product ID
53208-573_369a9de7-e8e9-4562-e063-6394a90ae245
Type
HUMAN OTC DRUG
Nonproprietary name
Sodium Fluoride
Dosage form
KIT
Route
DENTAL
Labeler
LG HOUSEHOLD & HEALTH CARE LTD.
Application
M021
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-07-07
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 GIFT SET
Brand name suffix
(40gX3)
Listing expiration
2026-12-31

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
369aa02f-c312-6a0d-e063-6294a90adaa5Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53208-566-43EUTHYMOL WHITENING GIFT SET(40gX3)40 g in 1 TUBEPASTE, DENTIFRICE120 g in 31.5 mg in 1g3
53208-566-46EUTHYMOL WHITENING GIFT SET(40gX3)3 in 1 CARTONPASTE, DENTIFRICE1.5 mg in 1g3
53208-573-00EUTHYMOL WHITENING GIFT SET(40gX3)1 in 1 CARTONKIT13

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 10 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Frida Fluoride Sweet MintSODIUM FLUORIDEFridababy, LLC4f8b5a39-5d79-72cd-e063-6394a90a475c2026-05-06WarningsExact identifier
application number: M021
Frida Fluoride Bubble MintSODIUM FLUORIDEFridababy, LLC4f8b9af3-e4b3-b5e0-e063-6394a90a10682026-05-06WarningsExact identifier
application number: M021
Frida Fluoride Strawberry Toothbrush SetSODIUM FLUORIDEFridababy, LLC4f8ba14f-60ea-c2a8-e063-6394a90a77022026-05-06WarningsExact identifier
application number: M021
Frida Fluoride StrawberrySODIUM FLUORIDEFridababy, LLC4f814a62-8f91-8ea6-e063-6294a90a69eb2026-05-06WarningsExact identifier
application number: M021
Gum Health DetoxifySTANNOUS FLUORIDEMeijer, Inc41d70733-a223-40fb-e063-6294a90a13972026-05-06WarningsExact identifier
application number: M021
Colgate Kids Unicorn Alcohol FreeSODIUM FLUORIDEColgate-Palmolive Company133acaff-7205-80d7-e91d-3eb37087cae42026-05-05WarningsExact identifier
application number: M021
Crest 3D White Stain EraserSODIUM FLUORIDEProcter & Gamble Manufactura, S. de R.L. de C.V.fdefffbd-9c05-fa30-e053-6394a90a34bc2026-05-05WarningsExact identifier
application number: M021
Frida Fluoride WatermelonSODIUM FLUORIDEFridababy, LLC4f8b49dc-e9e4-c341-e063-6294a90adb5a2026-05-05WarningsExact identifier
application number: M021
White Glo Extreme White WhiteningSODIUM MONOFLUOROPHOSPHATEWhite Glo USA Inc4a2e0a8d-420e-4c07-aa43-386d05dab4722026-04-30WarningsExact identifier
application number: M021
Equate Pro-Advanced TP Equate Pro-Advanced TPSTANNOUS FLUORIDEWalmart Inc.1e6561fb-4e3b-40ba-e063-6294a90a26902026-04-29WarningsExact identifier
application number: M021
Crest Cavity Protection RegularSODIUM FLUORIDEProcter & Gamble Manufactura, S. de R.L. de C.V.852889b4-59ba-4592-b4fc-c0127a1ad0752026-04-28WarningsExact identifier
application number: M021
Crest Complete Multi-Benefit Whitening plus ScopeSODIUM FLUORIDEProcter & Gamble Manufactura, S. de R.L. de C.V.0206710a-707f-4aa9-96b9-86240c1275dc2026-04-28WarningsExact identifier
application number: M021
Alcohol Free Refreshing MintSODIUM FLUORIDEH E Bcedf7c08-7412-4733-9b67-225b331cec8c2026-04-27Warnings, Adverse reactionsExact identifier
application number: M021
anzoon ANTIBACTERIAL MOUTH WASHCETYLPYRIDINIUM CHLORIDEShandong AZC Biotechnology Co.,Ltd.507c6896-2806-790c-e063-6394a90ac5ce2026-04-27WarningsExact identifier
application number: M021
DELTA COMFORT PLUS AMENITYSODIUM MONOFLUOROPHOSPHATEBuzz Products Inc.26434794-ae02-0f58-e063-6294a90ad85e2026-04-24WarningsExact identifier
application number: M021
A and H Plus Therabreath Breath FreshnersSODIUM FLUORIDEChurch & Dwight Co., Inc.18d6073e-b1ee-47d2-9758-2cf04f3cf3ca2026-04-23WarningsExact identifier
application number: M021
FluorideSODIUM FLUORIDEMcKesson5025e58e-e59c-07b6-e063-6394a90ac1e82026-04-23WarningsExact identifier
application number: M021
PRO-SYSSENSITIVITY - MINT (OTC)Benco Dental4e46847e-8c1d-c988-e063-6394a90a8e502026-04-22WarningsExact identifier
application number: M021
Anticavity Fluoride RinseSODIUM FLUORIDEH E B87327a36-a314-4daa-83b6-b4bd3e26bba22026-04-22Warnings, Adverse reactionsExact identifier
application number: M021
AnticavitySODIUM FLUORIDEH E B8df324a7-9204-40f3-8ddb-1656286d7d4e2026-04-22Warnings, Adverse reactionsExact identifier
application number: M021

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
891775sodium fluoride 0.243 % ToothpastePSN369aa02f-c312-6a0d-e063-6294a90adaa53
891775sodium fluoride 0.00243 MG/MG ToothpasteSCD369aa02f-c312-6a0d-e063-6294a90adaa53
891775sodium fluoride 0.243 % (fluoride ion 0.13 % ) ToothpasteSY369aa02f-c312-6a0d-e063-6294a90adaa53
891775sodium fluoride 0.243 % (fluoride ion 0.14 % ) ToothpasteSY369aa02f-c312-6a0d-e063-6294a90adaa53
891775sodium fluoride 0.243 % (fluoride ion 0.15 % ) ToothpasteSY369aa02f-c312-6a0d-e063-6294a90adaa53
891775sodium fluoride 0.243 % (fluoride ion 0.16 % ) ToothpasteSY369aa02f-c312-6a0d-e063-6294a90adaa53

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
53208-566-435320805664340 g in 1 TUBE40 gHistorical
53208-566-46532080566463 in 1 CARTONHistorical
53208-573-00532080573001 KIT in 1 CARTON (53208-573-00) * 3 TUBE in 1 CARTON (53208-566-46) / 40 g in 1 TUBE (53208-566-43) 1 kit2025-07-07NoNoCurrent