FDA.reportPublic FDA data

Innoble ONECHEWTOOTHPASTE

Manufacturer
livmate | SUNGWON PHARMACEUTICAL CO., LTD.
Effective date
2022-05-04
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:49:28

Label at a glance#

ProductInnoble ONECHEWTOOTHPASTE
Active ingredientSODIUM FLUORIDE, SILICON DIOXIDE, SODIUM PYROPHOSPHATE, PYRIDOXINE HYDROCHLORIDE
Label structure8 sections

Dosage and administration

Adults and children 6 years of age and older; Gently chew 1 tablet until it crushed. Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or doctor.

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

Silicon Dioxide, Tetrasodium Pyrophosphate, Pyridoxine Hydrochloride, Sodium Fluoride

INACTIVE INGREDIENT

INACTIVE INGREDIENT SECTION

D-Sorbitol, Sodium Cocoyl Glutamate, Sodium Cocoyl Isethionate, Microcrystalline Cellulose, Xylitol, Magnesium Stearate, Sodium Bicarbonate, Xanthan Gum, Hydroxypropylcellulose, Enzymatically Modified Stevia, L-Menthol, Bamboo Salt, Sodium Chloride, DL-Malic Acid, Combined Flavor(Coolmint Flavor Powder), Combined Flavor(Lemon Flavor Powder), Coconut Oil, Aloe Vera Gel, Carrot Extract, Calendula Extract

PURPOSE

OTC - PURPOSE SECTION

Anti plaque

Tartar Control

Anti Cavity

Against gum disease

KEEP OUT OF REACH OF CHILDREN

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

WARNING

WARNINGS SECTION

Do not use for children under 6 years of age.

Directions

DOSAGE & ADMINISTRATION SECTION

Adults and children 6 years of age and older; Gently chew 1 tablet until it crushed. Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or doctor.

INDICATION & USAGE SECTION

INDICATIONS & USAGE SECTION

Prevention of cavities, plaque, gum disease, gingivitis and periodontal disease.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabel

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
PYRIDOXINE Pharmacologic Class Indexing1Indexing - Pharmacologic Class20170310

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
59361619-24d9-b610-eca6-5a7f25ed5e03Product name520240909
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
5e18e798-5614-cf5c-0185-38b1cb77a093Product name220160822
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
82709-001-012024-01-30C16284748780-10191ceaa-6fe4-198a-e063-dbdaa90aec3ea8cedb67-afe9-4bc5-94fe-f1358281f4f7
82709-001-032024-01-30C16284748780-10191ceaa-6fe4-198a-e063-dbdaa90aec3ea8cedb67-afe9-4bc5-94fe-f1358281f4f7
82709-001-012023-12-28C16284748780-10191ceaa-6fe4-198a-e063-dbdaa90aec3ea8cedb67-afe9-4bc5-94fe-f1358281f4f7
82709-001-032023-12-28C16284748780-10191ceaa-6fe4-198a-e063-dbdaa90aec3ea8cedb67-afe9-4bc5-94fe-f1358281f4f7
82709-001-012023-07-28C16284748780-10191ceaa-6fe4-198a-e063-dbdaa90aec3ea8cedb67-afe9-4bc5-94fe-f1358281f4f7
82709-001-032023-07-28C16284748780-10191ceaa-6fe4-198a-e063-dbdaa90aec3ea8cedb67-afe9-4bc5-94fe-f1358281f4f7

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82709-001-01Innoble ONECHEWTOOTHPASTE84 g in 1 POUCHTABLET841
82709-001-02Innoble ONECHEWTOOTHPASTE42 g in 1 BOTTLE, GLASSTABLET421
82709-001-03Innoble ONECHEWTOOTHPASTE1 in 1 CARTONTABLET11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82709-001INNOBLE ONECHEWTOOTHPASTE (SODIUM FLUORIDE) TABLET [LIVMATE]1Legacy NDC, 3 package rows20220505_a8cedb67-afe9-4bc5-94fe-f1358281f4f7.zip

Products#

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

DailyMed product names page 1 of 1 · 23 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
82709-00182709-001-01, 82709-001-02, 82709-001-03

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 19 matching rows.

Name, UNII, Kind table
NameUNIIKind
SORBITOL506T60A25RIACT
SODIUM COCOYL GLUTAMATEBMT4RCZ3HGIACT
SODIUM COCOYL ISETHIONATE518XTE8493IACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
XYLITOLVCQ006KQ1EIACT
MAGNESIUM STEARATE70097M6I30IACT
SODIUM BICARBONATE8MDF5V39QOIACT
XANTHAN GUMTTV12P4NEEIACT
HYDROXYPROPYL CELLULOSE, UNSPECIFIED9XZ8H6N6OHIACT
LEVOMENTHOLBZ1R15MTK7IACT
SODIUM CHLORIDE451W47IQ8XIACT
MALIC ACID817L1N4CKPIACT
COCONUT OILQ9L0O73W7LIACT
ALOE VERA LEAFZY81Z83H0XIACT
CARROTL56Z1JK48BIACT
SODIUM FLUORIDE8ZYQ1474W7ACTIM
SILICON DIOXIDEETJ7Z6XBU4ACTIB
SODIUM PYROPHOSPHATEO352864B8ZACTIB
PYRIDOXINE HYDROCHLORIDE68Y4CF58BVACTIB

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
de341dbd-eeef-2e74-e053-2995a90ad220a8cedb67-afe9-4bc5-94fe-f1358281f4f72022-05-04WarningsExact identifier
spl id: de341dbd-eeef-2e74-e053-2995a90ad220
spl set id: a8cedb67-afe9-4bc5-94fe-f1358281f4f7

Reported adverse events (FAERS/openFDA)#

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