FDA.reportPublic FDA data

EUTHYMOL WHITENING SET

Product NDC
53208-568
11-digit product format
532080568
Labeler code
53208
Product ID
53208-568_358399ee-bc12-06a1-e063-6394a90a9d96
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
2025-06-09
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 SET
Listing expiration
2026-12-31

Harmonized Identifiers#

Field, Values table
FieldValues
Rxcui891775

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
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
53208-566-73EUTHYMOL 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
53208-568-00EUTHYMOL WHITENING SET1 in 1 CARTONKIT13

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
891775sodium fluoride 0.243 % ToothpastePSN35839b10-4c40-40e5-e063-6294a90a85b43
891775sodium fluoride 0.00243 MG/MG ToothpasteSCD35839b10-4c40-40e5-e063-6294a90a85b43
891775sodium fluoride 0.243 % (fluoride ion 0.13 % ) ToothpasteSY35839b10-4c40-40e5-e063-6294a90a85b43
891775sodium fluoride 0.243 % (fluoride ion 0.14 % ) ToothpasteSY35839b10-4c40-40e5-e063-6294a90a85b43
891775sodium fluoride 0.243 % (fluoride ion 0.15 % ) ToothpasteSY35839b10-4c40-40e5-e063-6294a90a85b43
891775sodium fluoride 0.243 % (fluoride ion 0.16 % ) ToothpasteSY35839b10-4c40-40e5-e063-6294a90a85b43

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
53208-566-6353208056663106 g in 1 TUBE106 gHistorical
53208-566-65532080566654 in 1 CARTONHistorical
53208-566-735320805667370 g in 1 TUBE70 gHistorical
53208-566-75532080566751 in 1 CARTONHistorical
53208-568-00532080568001 KIT in 1 CARTON (53208-568-00) * 4 TUBE in 1 CARTON (53208-566-65) / 106 g in 1 TUBE (53208-566-63) * 1 TUBE in 1 CARTON (53208-566-75) / 70 g in 1 TUBE (53208-566-73) 1 kit2025-06-09NoNoHistorical