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 25 of 50 · 995 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Crest Pro Health Advanced Enamel RestoreSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Companyd813f5f0-3135-4a8f-e053-2a95a90a55622026-01-08WarningsExact identifier
application number: M021
Crest 3D White BrillianceSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company8e189fbd-5094-4398-b96c-8f95d89b9cdd2026-01-08WarningsExact identifier
application number: M021
Crest Pro Health Densify RinseSODIUM FLUORIDEThe Procter & Gamble Manufacturing Companyd84fb9f9-f2bc-358a-e053-2995a90abf072026-01-08WarningsExact identifier
application number: M021
Kids Crest Strawberry RushSODIUM FLUORIDEThe Procter & Gamble Manufacturing Companyeb7a5698-754c-4e46-e053-2a95a90a57b42026-01-08WarningsExact identifier
application number: M021
Crest 3D White Brilliance Daily Cleansing and Whitening SystemSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Company89a6fb36-5109-47f1-95ad-9381471ceeef2026-01-08WarningsExact identifier
application number: M021
Crest Pro-Health Advanced w/Extra WhiteningSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company2c1c5563-0b7e-4c7c-b49f-3d72e078cd282026-01-08WarningsExact identifier
application number: M021
Crest 3D White Stain Eraser Fresh MintSODIUM FLUORIDEThe Procter & Gamble Manufacturing Companyc81ba39d-c7ea-b2a5-e053-2995a90a0fe72026-01-08Exact identifier
application number: M021
Crest Premium Plus Breath Bacteria BlastSTANNOUS FLUORIDEThe Procter & Gamble Manufacturing Companyc3f1d477-6dd8-0ac4-e053-2a95a90a37422026-01-08WarningsExact identifier
application number: M021
Crest Premium Plus Active Foam Whitening scopeSODIUM FLUORIDEThe Procter & Gamble Manufacturing Companyc72b15e0-e69c-65fc-e053-2a95a90a54c82026-01-08WarningsExact identifier
application number: M021
Crest Complete Plus Scope Outlast UltraSODIUM FLUORIDEThe Procter & Gamble Manufacturing Companyc3f63455-b09e-9877-e053-2a95a90a18442026-01-08WarningsExact identifier
application number: M021
Crest Tartar Protection Fresh Mint GelSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company3d81d605-4f9b-3bb5-e054-00144ff88e882026-01-08WarningsExact identifier
application number: M021
Crest Complete plus WhiteningSODIUM FLUORIDEThe Procter & Gamble Manufacturing Companye3b1f139-4fe8-f005-e053-2995a90a53b42026-01-08WarningsExact identifier
application number: M021
Crest 3D White Radiant MintSODIUM FLUORIDEThe Procter & Gamble Manufacturing Companyf3dd7a34-a0d8-4ac6-bbd1-7c3b86187a572026-01-08WarningsExact identifier
application number: M021
Crest Complete Plus Active Fresh plus Whitening ScopeSODIUM FLUORIDEThe Procter & Gamble Manufacturing Companyc599d33f-788f-7fdd-e053-2a95a90a5f572026-01-08WarningsExact identifier
application number: M021
Crest Complete Multi Benefit Whitening plus Scope OutlastSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company66c41b24-d394-6609-e053-2a91aa0a0a2c2026-01-08WarningsExact identifier
application number: M021
Crest Complete Plus 3 in 1SODIUM FLUORIDEThe Procter & Gamble Manufacturing Companyb6fab2eb-da5c-749f-e053-2995a90a13572026-01-08WarningsExact identifier
application number: M021
Crest Tartar ProtectionSODIUM FLUORIDEThe Procter & Gamble Manufacturing Company85477763-1db5-482f-90e5-e71f5c1b47652026-01-08WarningsExact identifier
application number: M021
Crest Fresh and WhiteSODIUM FLUORIDEThe Procter & Gamble Manufacturing Companyf9b31f6b-6b3f-abe0-e053-6294a90acb252026-01-08WarningsExact identifier
application number: M021
Crest Complete plus Whitening Deep CleanSODIUM FLUORIDEThe Procter & Gamble Manufacturing Companyc367c2cc-5e0f-bc4e-e053-2995a90a2e2c2026-01-08WarningsExact identifier
application number: M021
Crest 3D White Glamorous WhiteSODIUM FLUORIDEThe Procter & Gamble Manufacturing Companyc3f29f95-81b9-3989-e053-2a95a90af3a62026-01-08WarningsExact 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