EUTHYMOL Extraordinary Pink Whitening

Product NDC
53208-561
11-digit product format
532080561
Labeler code
53208
Product ID
53208-561_139125f6-2d2e-e67a-e063-6394a90adf57
Type
HUMAN OTC DRUG
Nonproprietary name
Sodium Fluoride
Dosage form
PASTE, DENTIFRICE
Route
DENTAL
Labeler
LG H&H CO., LTD.
Application
M021
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-03-13
Substance
SODIUM FLUORIDE
Active strength
1.6 mg/g
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
EUTHYMOL Extraordinary Pink Whitening
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SODIUM FLUORIDE1.6 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii8ZYQ1474W7
Rxcui891775

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53208-561-06EUTHYMOL Extraordinary Pink Whitening106 g in 1 TUBEPASTE, DENTIFRICE1062
53208-561-06EUTHYMOL Extraordinary Pink Whitening1 in 1 CARTONPASTE, DENTIFRICE12
53208-561-63EUTHYMOL Extraordinary Pink Whitening3 in 1 PACKAGEPASTE, DENTIFRICE31
53208-561-63EUTHYMOL Extraordinary Pink Whitening106 g in 1 TUBEPASTE, DENTIFRICE1061
53208-561-65EUTHYMOL Extraordinary Pink Whitening5 in 1 PACKAGEPASTE, DENTIFRICE51

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53208-561EUTHYMOL EXTRAORDINARY PINK WHITENING (SODIUM FLUORIDE) PASTE, DENTIFRICE [LG H&H CO., LTD.]2Current NDC, 2 package rows20250125_05b1f105-6f75-7a45-e063-6394a90a58bc.zip
53208-561EUTHYMOL EXTRAORDINARY PINK WHITENING (SODIUM FLUORIDE) PASTE, DENTIFRICE [LG H&H CO., LTD.]1Current NDC, 3 package rows20240315_13910b55-9b5d-af53-e063-6294a90acf5d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
891775sodium fluoride 0.243 % ToothpastePSN05b1f105-6f75-7a45-e063-6394a90a58bc2
891775sodium fluoride 0.00243 MG/MG ToothpasteSCD05b1f105-6f75-7a45-e063-6394a90a58bc2
891775sodium fluoride 0.243 % (fluoride ion 0.13 % ) ToothpasteSY05b1f105-6f75-7a45-e063-6394a90a58bc2
891775sodium fluoride 0.243 % (fluoride ion 0.14 % ) ToothpasteSY05b1f105-6f75-7a45-e063-6394a90a58bc2
891775sodium fluoride 0.243 % (fluoride ion 0.15 % ) ToothpasteSY05b1f105-6f75-7a45-e063-6394a90a58bc2
891775sodium fluoride 0.243 % (fluoride ion 0.16 % ) ToothpasteSY05b1f105-6f75-7a45-e063-6394a90a58bc2
891775sodium fluoride 0.243 % ToothpastePSN13910b55-9b5d-af53-e063-6294a90acf5d1
891775sodium fluoride 0.00243 MG/MG ToothpasteSCD13910b55-9b5d-af53-e063-6294a90acf5d1
891775sodium fluoride 0.243 % (fluoride ion 0.13 % ) ToothpasteSY13910b55-9b5d-af53-e063-6294a90acf5d1
891775sodium fluoride 0.243 % (fluoride ion 0.14 % ) ToothpasteSY13910b55-9b5d-af53-e063-6294a90acf5d1
891775sodium fluoride 0.243 % (fluoride ion 0.15 % ) ToothpasteSY13910b55-9b5d-af53-e063-6294a90acf5d1
891775sodium fluoride 0.243 % (fluoride ion 0.16 % ) ToothpasteSY13910b55-9b5d-af53-e063-6294a90acf5d1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
53208-561-06532080561061 TUBE in 1 CARTON (53208-561-06) / 106 g in 1 TUBE1 tube2023-09-18NoNoHistorical
53208-561-63532080561633 in 1 PACKAGEHistorical
53208-561-65532080561655 PACKAGE in 1 PACKAGE (53208-561-65) / 3 TUBE in 1 PACKAGE (53208-561-63) / 106 g in 1 TUBE5 package2024-03-13NoNoHistorical