FDA.reportPublic FDA data

Dentree

Manufacturer
E-SOUP Co., Ltd. | E-SOUP Co., Ltd
Effective date
2020-04-20
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:07:10

Label at a glance#

ProductDentree
Active ingredientSODIUM FLUORIDE
Label structure9 sections

Dosage and administration

Adults and children 6 years of age and older Brushless: shake the container before pumping 2-3 times on a toothbrush to brush the teeth or into mouth for close-mouthed; gurgle the foam inside the mouth for about 30 seconds. Rinse off the residue with clean water several times to achieve the intended cleanliness. With Brush: after gurgle the foam inside the mouth for about 30 seconds, you may use toothbrush to clea...

Storage and handling

store at room temperature.

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Sodium fluoride-------------------0.22%
(1000 ppm of fluoride ion)

Purpose

OTC - PURPOSE SECTION

Anticavity

Use

INDICATIONS & USAGE SECTION

aids in the prevention of dental cavities, reducing halitosis, and tooth whitening

Warnings

WARNINGS SECTION

keep out of reach of children.
If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

Adults and children 6 years of age and older

Brushless: shake the container before pumping 2-3 times on a toothbrush to brush the teeth or into mouth for close-mouthed; gurgle the foam inside the mouth for about 30 seconds. Rinse off the residue with clean water several times to achieve the intended cleanliness.

With Brush: after gurgle the foam inside the mouth for about 30 seconds, you may use toothbrush to clean before rinse.

Children under 6 years old
ask a dentist or physician

Other Information

STORAGE AND HANDLING SECTION

store at room temperature.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Allantoin, Ginger, Tribasic Calcium Phosphate,  Lingusticum Wallichii Whole, Artemisia princeps leaf, water

Questions or Comments?

OTC - QUESTIONS SECTION

call +82(53)584 3320

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANELPRINCIPAL DISPLAY PANEL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
245598sodium fluoride 0.22 % ToothpastePSN2
245598sodium fluoride 0.0022 MG/MG ToothpasteSCD2
245598sodium fluoride 0.22 % (fluoride 0.1 % ) ToothpasteSY2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
76170-102-012022-01-28C16284748780-19855d018-eb88-cd31-e053-dbdaa90ab51aDrug Facts
76170-102-022022-01-28C16284748780-19855d018-eb88-cd31-e053-dbdaa90ab51aDrug Facts
76170-102-032022-01-28C16284748780-19855d018-eb88-cd31-e053-dbdaa90ab51aDrug Facts
76170-102-012020-04-20C16284748780-19855d018-eb88-cd31-e053-dbdaa90ab51aDrug Facts
76170-102-022020-04-20C16284748780-19855d018-eb88-cd31-e053-dbdaa90ab51aDrug Facts
76170-102-032020-04-20C16284748780-19855d018-eb88-cd31-e053-dbdaa90ab51aDrug Facts
76170-102-012019-11-27C16284748780-19855d018-eb88-cd31-e053-dbdaa90ab51aDrug Facts
76170-102-022019-11-27C16284748780-19855d018-eb88-cd31-e053-dbdaa90ab51aDrug Facts
76170-102-032019-11-27C16284748780-19855d018-eb88-cd31-e053-dbdaa90ab51aDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76170-102-01Dentree30 mL in 1 BOTTLE, PUMPGEL, DENTIFRICE302
76170-102-01Dentree1 in 1 CARTONGEL, DENTIFRICE12
76170-102-02Dentree1 in 1 CARTONGEL, DENTIFRICE12
76170-102-02Dentree50 mL in 1 BOTTLE, PUMPGEL, DENTIFRICE502
76170-102-03Dentree100 mL in 1 BOTTLE, PUMPGEL, DENTIFRICE1002
76170-102-03Dentree1 in 1 CARTONGEL, DENTIFRICE12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76170-102DENTREE (SODIUM FLUORIDE) GEL, DENTIFRICE [E-SOUP CO., LTD.]2Legacy NDC, 6 package rows20200421_b30f2f18-0966-1f6b-e2fd-32e49555aa28.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
Sodium FluorideACTIVE INGREDIENT8ZYQ1474W71
Fluoride IonACTIVE MOIETYQ80VPU408O1
AllantoinINACTIVE INGREDIENT344S277G0Z1
Artemisia Princeps LeafINACTIVE INGREDIENTSY077EW02G1
GingerINACTIVE INGREDIENTC5529G5JPQ1
Ligusticum Wallichii WholeINACTIVE INGREDIENT8Y1N3NX2DW1
Tribasic Calcium PhosphateINACTIVE INGREDIENT91D9GV0Z281
WaterINACTIVE INGREDIENT059QF0KO0R1

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
76170-10276170-102-01, 76170-102-02, 76170-102-03

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALLANTOIN344S277G0ZIACT
GINGERC5529G5JPQIACT
TRIBASIC CALCIUM PHOSPHATE91D9GV0Z28IACT
LIGUSTICUM WALLICHII WHOLE8Y1N3NX2DWIACT
ARTEMISIA PRINCEPS LEAFSY077EW02GIACT
WATER059QF0KO0RIACT
SODIUM FLUORIDE8ZYQ1474W7ACTIB

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 13 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
Tribasic Calcium PhosphateTRIBASIC CALCIUM PHOSPHATE91D9GV0Z28TABLET / SUBLINGUAL99.2 mgExact identifier — unii candidate
10 equally ranked IID candidates
AllantoinALLANTOIN344S277G0ZGEL / TOPICAL8 mgExact identifier — unii candidate
Tribasic Calcium PhosphateTRIBASIC CALCIUM PHOSPHATE91D9GV0Z28CAPSULE, EXTENDED RELEASE / ORAL32.73 mgExact identifier — unii candidate
10 equally ranked IID candidates
Tribasic Calcium PhosphateTRIBASIC CALCIUM PHOSPHATE91D9GV0Z28TABLET / BUCCAL99.2 mgExact identifier — unii candidate
10 equally ranked IID candidates
GingerGINGERC5529G5JPQSYRUP / ORAL0.05 ml/5mlExact identifier — unii candidate
2 equally ranked IID candidates
Tribasic Calcium PhosphateTRIBASIC CALCIUM PHOSPHATE91D9GV0Z28TABLET / ORAL330 mgExact identifier — unii candidate
10 equally ranked IID candidates
Tribasic Calcium PhosphateTRIBASIC CALCIUM PHOSPHATE91D9GV0Z28CAPSULE / ORAL176 mgExact identifier — unii candidate
10 equally ranked IID candidates
Tribasic Calcium PhosphateTRIBASIC CALCIUM PHOSPHATE91D9GV0Z28TABLET, EXTENDED RELEASE / ORAL750 mgExact identifier — unii candidate
10 equally ranked IID candidates
Tribasic Calcium PhosphateTRIBASIC CALCIUM PHOSPHATE91D9GV0Z28TABLET, FILM COATED / ORAL21.8 mgExact identifier — unii candidate
10 equally ranked IID candidates
Tribasic Calcium PhosphateTRIBASIC CALCIUM PHOSPHATE91D9GV0Z28TABLET, CHEWABLE / ORAL130 mgExact identifier — unii candidate
10 equally ranked IID candidates
Tribasic Calcium PhosphateTRIBASIC CALCIUM PHOSPHATE91D9GV0Z28TABLET, DELAYED RELEASE / ORAL333.3 mgExact identifier — unii candidate
10 equally ranked IID candidates
Tribasic Calcium PhosphateTRIBASIC CALCIUM PHOSPHATE91D9GV0Z28TABLET, COATED / ORAL40 mgExact identifier — unii candidate
10 equally ranked IID candidates
GingerGINGERC5529G5JPQELIXIR / ORAL10 mg/5mlExact identifier — unii candidate
2 equally ranked IID candidates

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
a3be8bbd-6419-2574-e053-2a95a90a3f6cb30f2f18-0966-1f6b-e2fd-32e49555aa282020-04-20WarningsExact identifier
spl id: a3be8bbd-6419-2574-e053-2a95a90a3f6c
spl set id: b30f2f18-0966-1f6b-e2fd-32e49555aa28

Reported adverse events (FAERS/openFDA)#

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