FDA.reportPublic FDA data

Euthymol Whitening Purple Corrector

Product NDC
53208-563
11-digit product format
532080563
Labeler code
53208
Product ID
53208-563_3259ca3a-5b64-33e3-e063-6294a90af80c
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
2025-05-01
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 Purple Corrector
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
416783Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
300303e7-ef8b-7449-e063-6294a90ac811Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53208-563-62Euthymol Whitening Purple Corrector2 in 1 CELLO PACKPASTE, DENTIFRICE25
53208-563-63Euthymol Whitening Purple Corrector106 g in 1 TUBEPASTE, DENTIFRICE1065
53208-563-64Euthymol Whitening Purple Corrector3 in 1 CELLO PACKPASTE, DENTIFRICE35
53208-563-63Euthymol Whitening Purple Corrector106 g in 1 TUBEPASTE, DENTIFRICE1062
53208-563-65Euthymol Whitening Purple Corrector1 in 1 CARTONPASTE, DENTIFRICE12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53208-563EUTHYMOL WHITENING PURPLE CORRECTOR (SODIUM FLUORIDE) PASTE, DENTIFRICE [LG HOUSEHOLD & HEALTH CARE LTD.]2Current NDC, 2 package rows20250501_300303e7-ef8b-7449-e063-6294a90ac811.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 50 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
United Airlines Therabody Polaris KitSODIUM MONOFLUOROPHOSPHATEWessco Internationalab667740-55ab-470e-9514-163961502ceb2023-10-26WarningsExact identifier
application number: M021
Cavity Protection Fresh MintSODIUM FLUORIDEOxyfresh Worldwide Inc0ae98f28-7e78-4379-93b0-4f2657415c4d2023-10-25WarningsExact identifier
application number: M021
Tanners Tasty Vanilla BlingSODIUM FLUORIDESheffield Pharmaceuticals LLC521fe01e-7f2e-4d79-9126-e4880cdf4e712023-10-24WarningsExact identifier
application number: M021
Tanners Tasty Ooh La La OrangeSODIUM FLUORIDESheffield Pharmaceuticals LLC6027b961-314e-4f71-8b2f-646ce80214d82023-10-24WarningsExact identifier
application number: M021
Tanners Tasty Cha Cha ChocolateSODIUM FLUORIDESheffield Pharmaceuticals LLC8609dbf3-7620-4a13-b40b-6bd705a78fb02023-10-24WarningsExact identifier
application number: M021
Glister Multi-ActionSODIUM FLUORIDEAccess Business Group LLCe3f2c049-a0f5-4649-a4aa-11bdb252f9512023-10-23WarningsExact identifier
application number: M021
UNITED Asutra TC Kit ColgateSODIUM MONOFLUOROPHOSPHATEMING FAI ENTERPRISE (CAMBODIA) CO., LTD082a581a-c7e5-e614-e063-6394a90a87da2023-10-20WarningsExact identifier
application number: M021
Plak Smacker Anti Cavity FluorideSODIUM FLUORIDEYOUNG PS ACQUISITION, LLCc6dee5fa-9cd4-4a94-9cbe-e977b2bd3dfe2023-10-16WarningsExact identifier
application number: M021
Ionite HSTANNOUS FLUORIDEDharma Research, Inc.152d84ee-d981-4032-bfb1-a559afe71d402023-10-11WarningsExact identifier
application number: M021
Sodium FluorideSODIUM FLUORIDESafco Dental Supply LLC788080b3-fff8-4049-af98-f571824994c22023-10-11WarningsExact identifier
application number: M021
Ionite HSTANNOUS FLUORIDEDharma Research, Inc.5c312b36-07f4-406e-b3d3-c6d1e964635d2023-10-11WarningsExact identifier
application number: M021
Ionite HSTANNOUS FLUORIDEDharma Research, Inc.042636cf-8b61-4022-b0a1-af09c06b145b2023-10-11WarningsExact identifier
application number: M021
Ionite HSTANNOUS FLUORIDEDharma Research, Inc.f4c3569b-7b6a-4566-9e87-492f291c51652023-10-11WarningsExact identifier
application number: M021
UNITED Asutra TC Kit ColgateSODIUM MONOFLUOROPHOSPHATEProcurall Solutions042817f9-675f-056a-e063-6394a90a2d972023-08-30WarningsExact identifier
application number: M021
Colgate Max Fresh Cool MintSODIUM FLUORIDEMission Hills S.A de C.Vd142e43f-415a-41c5-a7db-8b18a039a3232019-04-09WarningsExact identifier
application number: M021

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
416783sodium fluoride 0.24 % ToothpastePSN369bc785-fb77-a56d-e063-6394a90a2e6b5
416783sodium fluoride 0.0024 MG/MG ToothpasteSCD369bc785-fb77-a56d-e063-6394a90a2e6b5
416783sodium fluoride 0.24 % (fluoride ion 0.13 % ) ToothpasteSY369bc785-fb77-a56d-e063-6394a90a2e6b5
416783sodium fluoride 0.24 % (fluoride ion 0.14 % ) ToothpasteSY369bc785-fb77-a56d-e063-6394a90a2e6b5
416783sodium fluoride 0.24 % (fluoride ion 0.15 % ) ToothpasteSY369bc785-fb77-a56d-e063-6394a90a2e6b5
416783sodium fluoride 0.24 % ToothpastePSN300303e7-ef8b-7449-e063-6294a90ac8112
416783sodium fluoride 0.0024 MG/MG ToothpasteSCD300303e7-ef8b-7449-e063-6294a90ac8112
416783sodium fluoride 0.24 % (fluoride ion 0.13 % ) ToothpasteSY300303e7-ef8b-7449-e063-6294a90ac8112
416783sodium fluoride 0.24 % (fluoride ion 0.14 % ) ToothpasteSY300303e7-ef8b-7449-e063-6294a90ac8112
416783sodium fluoride 0.24 % (fluoride ion 0.15 % ) ToothpasteSY300303e7-ef8b-7449-e063-6294a90ac8112

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
53208-563-20532080563201 TUBE in 1 CARTON (53208-563-20) / 20 g in 1 TUBE1 tube2026-06-30NoNoCurrent
53208-563-62532080563622 CELLO PACK in 1 CELLO PACK (53208-563-62) / 3 TUBE in 1 CELLO PACK (53208-563-64) / 106 g in 1 TUBE (53208-563-63) 2 cello pack2025-09-09NoNoCurrent
53208-563-6353208056363106 g in 1 TUBE106 gHistorical
53208-563-64532080563643 in 1 CELLO PACKHistorical
53208-563-65532080563651 TUBE in 1 CARTON (53208-563-65) / 106 g in 1 TUBE (53208-563-63) 1 tube2025-05-01NoNoCurrent