FDA.reportPublic FDA data

QUANTUMTOOTHCARE TOOTH

Manufacturer
HealingStory.,LTD. | Sungwon Pharmaceutical
Effective date
2021-03-04
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:38:45

Label at a glance#

ProductQUANTUMTOOTHCARE TOOTH
Active ingredientSILICON DIOXIDE, .ALPHA.-TOCOPHEROL ACETATE, SODIUM PYROPHOSPHATE
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Silicon Dioxide

Tocopherol Acetate

Tetrasodium Pyrophosphate

INACTIVE INGREDIENT SECTION

D-Sorbitol Solution

Concentrated Glycerin
Carboxymethylcellulose Sodium

Hydroxyapatite

Medicinal Carbon

Chitosan

Mica

Zeolite

Xylitol

Steviol Glycoside

Papain

Grapefruit Seed Extract

L-Menthol

Mentha Oil

Propolis Extract

Chamomile Extract

Rosemary Extract

Sage Extract

Aloe Extract

Glycyrrhiza Extract

Horsetail Extract

Lavender Oil

Sodium Cocoyl Glutamate

Lauroyl Amidopropyl Dimethyl Glycine Solution

Deionized Water

OTC - PURPOSE SECTION

For dental care

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children

INDICATIONS & USAGE SECTION

Apply an appropriate amount to your toothbrush and brush your teeth by brushing.

WARNINGS SECTION

Warnings

Keep out of reach of children

■ If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Other Information

■ Store in an airtight container at room temperature

■ Date of use : 36 months from the date of manufacture

DOSAGE & ADMINISTRATION SECTION

For dental use only

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

11

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
81659-0001-12024-01-30C16284748780-10191ceaa-68f9-198a-e063-dbdaa90aec3ebcb081cc-30b5-12b1-e053-2a95a90a0858
81659-0001-12023-12-28C16284748780-10191ceaa-68f9-198a-e063-dbdaa90aec3ebcb081cc-30b5-12b1-e053-2a95a90a0858
81659-0001-12023-07-28C16284748780-10191ceaa-68f9-198a-e063-dbdaa90aec3ebcb081cc-30b5-12b1-e053-2a95a90a0858

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81659-0001-1QUANTUMTOOTHCARE TOOTH100 g in 1 TUBEPASTE, DENTIFRICE1001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81659-0001QUANTUMTOOTHCARE TOOTH (SILICON DIOXIDE, TOCOPHEROL ACETATE, TETRASODIUM PYROPHOSPHATE) PASTE, DENTIFRICE [HEALINGSTORY.,LTD.]1Legacy NDC, 1 package rows20210305_bcb081cc-30b5-12b1-e053-2a95a90a0858.zip

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
81659-000181659-0001-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
XYLITOLVCQ006KQ1EIACT
WATER059QF0KO0RIACT
SILICON DIOXIDEETJ7Z6XBU4ACTIB
TRIBASIC CALCIUM PHOSPHATE91D9GV0Z28IACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0ACTIB
SODIUM PYROPHOSPHATEO352864B8ZACTIB

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
bcb06353-8338-ac06-e053-2995a90a2050bcb081cc-30b5-12b1-e053-2a95a90a08582021-03-04WarningsExact identifier
spl id: bcb06353-8338-ac06-e053-2995a90a2050
spl set id: bcb081cc-30b5-12b1-e053-2a95a90a0858

Reported adverse events (FAERS/openFDA)#

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