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 19 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Burts Bees Charcoal PeppermintSODIUM FLUORIDEProcter & Gamble Manufacturing Companya343853e-4968-2753-e053-2995a90ab1522026-02-02WarningsExact identifier
application number: M021
Burts Bees Complete Multi-CareSODIUM FLUORIDEProcter & Gamble Manufacturing Company12615266-06e8-b891-e063-6394a90ad75d2026-02-02WarningsExact identifier
application number: M021
LIVFRESH GUM PROTECTSTANNOUS FLUORIDELivionex Inc.1da7dcf9-e675-4b4b-8286-bdaa6e59eb0f2026-02-02WarningsExact identifier
application number: M021
Brush Buddies Mouthwash Disney Cars Chow CherrySODIUM FLUORIDEKingkey MBC Life Technology Group co., LTD.49d66ad5-cdae-52f4-e063-6294a90a8ee92026-02-01WarningsExact identifier
application number: M021
Crest 3D White Deep Stain Remover Brilliant WhiteSODIUM MONOFLUOROPHOSPHATEThe Procter & Gamble Manufacturing Company4e53a086-6cda-6460-e063-6394a90af1f32026-02-01Exact identifier
application number: M021
ACT Kids Berry BlastSODIUM FLUORIDEChattem, Inc.4f81ea98-5c74-4473-9764-3f11d627cdf12026-02-01WarningsExact identifier
application number: M021
Anticavity RinseSODIUM FLUORIDERite Aid Corporationc1a22692-b955-498a-a7c1-1cd7bfd54bda2026-01-30Warnings, Adverse reactionsExact identifier
application number: M021
ARU GUM HEALTHSTANNOUS FLUORIDEAshtel Studios, Inc.d8e8b92e-d8cb-45ad-8353-7dbe43c3dcd32026-01-30WarningsExact identifier
application number: M021
Colgate AnticavitySODIUM MONOFLUOROPHOSPHATEFORMIA LIMITEDb5eec445-d93a-4abb-a5e3-bfcde6fa20132026-01-28WarningsExact identifier
application number: M021
Supersmile Original MintSODIUM MONOFLUOROPHOSPHATERobell Research, Inc24fee793-57ed-87e9-e063-6394a90ab4ce2026-01-28WarningsExact identifier
application number: M021
Colgate 5g and Toothbrush Dental KitSODIUM MONOFLUOROPHOSPHATEFORMIA LIMITED0b269f9a-aa3f-47b5-b7e8-59a5ed0e2b132026-01-28WarningsExact identifier
application number: M021
Brush Buddies SPIDEY and his AMAZING FRIENDS ANTICAVITY FLUORIDE-Spidey PunchSODIUM FLUORIDEAshtel Studios Inc.023cb63c-52b4-4723-bff6-c25105a53f762026-01-28WarningsExact identifier
application number: M021
Brush Buddies STAR WARS ANTICAVITY FLUORIDE - Saber Strike StrawberrySODIUM FLUORIDEAshtel Studios, Inc.ef4ea4a3-c1ac-447f-a70b-e3a330928cfd2026-01-27WarningsExact identifier
application number: M021
Toms of Maine Tropical IslandALUMINUM CHLOROHYDRATETom's of Maineae6de376-76fd-4609-a2d5-7a902c0d4c5c2026-01-27WarningsExact identifier
application number: M021
Made by Dentists for Kids Fluoride Anticavity Bamboolicious (Bubblegum)SODIUM FLUORIDEMade by Dentists Inc.f3f6b32d-8e47-4f52-bd9a-20bd51c9d0072026-01-27WarningsExact identifier
application number: M021
Brush Buddies DISNEY PRINCESS ANTICAVITY FLUORIDE - Grand GrapeSODIUM FLUORIDEAshtel Studios Inc.6c6d143f-4c2b-4207-bde7-9df8251616a32026-01-27WarningsExact identifier
application number: M021
Brush Buddies TOY STORY ANTICAVITY FLUORIDE - WILD WEST WATERMELONSODIUM FLUORIDEAshtel Studios, Inc.d80d0a87-5d1f-4114-977a-036ffed772052026-01-27WarningsExact identifier
application number: M021
Brush Buddies DISNEY FROZEN ANTICAVITY FLUORIDE - Blizzard BerrySODIUM FLUORIDEAshtel Studios, Inc.ac18dd0a-d476-48a7-8493-594a0293b9262026-01-27WarningsExact identifier
application number: M021
Brush Buddies Cars ANTICAVITY FLUORIDE - KA-CHOW CHERRYSODIUM FLUORIDEAshtel Studios, Inc.2500e14e-6cf4-4ac4-810f-1ef163c5e4742026-01-27WarningsExact identifier
application number: M021
Hello Unicorn SplashSODIUM FLUORIDEAccupac LLC23807810-990a-b723-e063-6394a90aee3e2026-01-22WarningsExact 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