FDA.reportPublic FDA data

EUTHYMOL Extraordinary Pink Whitening

Manufacturer
Tai Guk Pharm. Co., Ltd. | LG H&H CO., LTD. | Tai Guk Pharma. Co., Ltd.
Effective date
2025-01-01
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:50:24

Label at a glance#

ProductEUTHYMOL Extraordinary Pink Whitening
Active ingredientSODIUM FLUORIDE
Label structure9 sections

Dosage and administration

adults and children 2 years of age and and older: Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist. ​Do not swallow. ​to minimize swallowing use a pea-sized amount in children under 6. ​Supervise children's brushing until good habits are established. ​ Children under 2 years: ask a dentist.

Label contents#

Full prescribing information#

Drug Facts

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Sodium Fluoride 0.243% (0.16% w/v fluoride ion)

Purpose

OTC - PURPOSE SECTION

Anticavity toopaste

Use

INDICATIONS & USAGE SECTION

helps protect against cavities

Warnings

WARNINGS SECTION

Warnings

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children under 6 years of age.Do not swallow. If you accidentally swallow more than used for brushing, seek professional assistance or contact a poison control center right away. If an allergic reaction develops, discontinue use immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

  • adults and children 2 years of age and and older: Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist.
  • ​Do not swallow.
  • ​to minimize swallowing use a pea-sized amount in children under 6.
  • ​Supervise children's brushing until good habits are established.
  • ​ Children under 2 years: ask a dentist.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

GLYCERIN, HYDRATED SILICA, SODIUM HEXAMETAPHOSPHATE, WATER, PEG-6, FLAVOR, TRISODIUM PHOSPHATE, SODIUM LAURYL SULFATE, CARRAGEENAN, COCAMIDOPROPYL BETAINE, SODIUM SACCHARIN, SUCRALOSE, XANTHAN GUM, TITANIUM DIOXIDE, MICA, CHARCOAL POWDER, CITRUS LIMON(LEMON) FRUIT EXTRACT, SODIUM CHLORIDE

Questions?

OTC - QUESTIONS SECTION

1-866-993-4709

Principal Display Panel - 20 g Tube Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

EXTRAORDINARY

PINK WHITENING

EUTHYMOL


Whiter Teeth in Just 1 Week

Formulated without BPA, phthalates, preservatives, peroxide, or animal ingredients.

Fluoride Toothpaste

Wintergreen Mint

net wt. 0.7 oz (20 g)

DIST. LG H&H CO., LTD.
58, SAEMUNAN-RO, JONGNO-GU, SEOUL, KOREA
www.lghnh.com
MADE IN KOREA

Euthymol_extraordinary_pink_whitening_20gEuthymol_extraordinary_pink_whitening_20g

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
891775sodium fluoride 0.243 % ToothpastePSN3
891775sodium fluoride 0.00243 MG/MG ToothpasteSCD3
891775sodium fluoride 0.243 % (fluoride ion 0.13 % ) ToothpasteSY3
891775sodium fluoride 0.243 % (fluoride ion 0.14 % ) ToothpasteSY3
891775sodium fluoride 0.243 % (fluoride ion 0.15 % ) ToothpasteSY3
891775sodium fluoride 0.243 % (fluoride ion 0.16 % ) ToothpasteSY3

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
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
43136-502-20EUTHYMOL Extraordinary Pink Whitening20 g in 1 TUBEPASTE, DENTIFRICE203
43136-502-20EUTHYMOL Extraordinary Pink Whitening1 in 1 CARTONPASTE, DENTIFRICE13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43136-502EUTHYMOL EXTRAORDINARY PINK WHITENING (SODIUM FLUORIDE) PASTE, DENTIFRICE [TAI GUK PHARM. CO., LTD.]3Current NDC, 2 package rows20250103_098a29d5-3836-d362-e063-6394a90a9fea.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 21 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
43136-50243136-502-20

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 18 matching rows.

Name, UNII, Kind table
NameUNIIKind
POLYETHYLENE GLYCOL 3005655G9Y8AQIACT
SODIUM POLYMETAPHOSPHATEP1BM4ZH95LIACT
CARRAGEENAN5C69YCD2YJIACT
GLYCERINPDC6A3C0OXIACT
WATER059QF0KO0RIACT
COCAMIDOPROPYL BETAINE5OCF3O11KXIACT
SODIUM PHOSPHATE, TRIBASIC, ANHYDROUSSX01TZO3QZIACT
SODIUM LAURYL SULFATE368GB5141JIACT
XANTHAN GUMTTV12P4NEEIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
SUCRALOSE96K6UQ3ZD4IACT
TITANIUM DIOXIDE15FIX9V2JPIACT
CITRUS LIMON FRUIT OIL0HNC1J1YEDIACT
SODIUM CHLORIDE451W47IQ8XIACT
HYDRATED SILICAY6O7T4G8P9IACT
MICAV8A1AW0880IACT
ACTIVATED CHARCOAL2P3VWU3H10IACT
SODIUM FLUORIDE8ZYQ1474W7ACTIM

Source Document#

Source XML

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 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
EUTHYMOL Extraordinary Pink WhiteningSODIUM FLUORIDETai Guk Pharm. Co., Ltd.098a29d5-3836-d362-e063-6394a90a9fea2025-01-01WarningsExact identifier
ndc (package): 43136-502-20
ndc (product): 43136-502
ndc11 (package): 43136050220
spl id: 2aabd54c-d97b-e892-e063-6394a90a1d9e
spl set id: 098a29d5-3836-d362-e063-6394a90a9fea

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.