FDA.reportPublic FDA data

Olea Olidental

Manufacturer
AJU PHARM CO., LTD.
Effective date
2017-01-21
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:48:36

Label at a glance#

ProductOlea Olidental
Active ingredientSILICON DIOXIDE
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Silicon Dioxide 17%

OTC - PURPOSE SECTION

Dental Care

INDICATIONS & USAGE SECTION

To improve dental health and bad breath

DOSAGE & ADMINISTRATION SECTION

Adults and children 2 years of age and older brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or physician

Children 2 to 6 years use only a pea sized amount and supervise child's brushing and rinsing (to minimize swallowing)

Children under 2 years ask a dentist or physician

WARNINGS SECTION

Keep out of the reach of children under 6 years of age. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of the reach of children under 6 years of age.

INACTIVE INGREDIENT SECTION

Aluminium Chlorohydroxy Allantoinate
Aminocaproic Acid
Chamomile Extract
Eucalyptus Extract
Sage Extract
Aloe Extract
Grapefruit Seed Extract
Propolis Powder
D-Sorbitol Solution
Concentrated Glycerin
Xantangum
Xylitol
Glucosyl Stevia
Olive Leaf Extract
Hydroxyapatite
Sodium Cocoyl Glutamate
Mint Flavor
Begamot Flavor
Solvent

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
83904ae6-37b6-4aa3-b6c9-663bc8d6ab8dProduct name920250103
e89c33e6-9224-49b0-4d80-05239f586f24Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70417-002-022020-01-31C16284748780-19d75b9d1-1f62-f424-e053-dadaa90a57ceDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70417-002-01Olea Olidental120 g in 1 TUBEPASTE1201
70417-002-02Olea Olidental1 in 1 CARTONPASTE11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70417-002OLEA OLIDENTAL (SILICON DIOXIDE) PASTE [AJU PHARM CO., LTD.]1Legacy NDC, 2 package rows20170121_5167b6ee-90b7-4066-ae14-e518c7eafe50.zip

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70417-00270417-002-01, 70417-002-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALCLOXA18B8O9DQA2IACT
AMINOCAPROIC ACIDU6F3787206IACT
CHAMOMILEFGL3685T2XIACT
EUCALYPTUS GLOBULUS LEAFS546YLW6E6IACT
CLARY SAGEU3HSK5JC0QIACT
ALOEV5VD430YW9IACT
CITRUS PARADISI SEED12F08874Y7IACT
PROPOLIS WAX6Y8XYV2NOFIACT
GLYCERINPDC6A3C0OXIACT
XANTHAN GUMTTV12P4NEEIACT
XYLITOLVCQ006KQ1EIACT
GLUCOSYL STEVIOLTKD5UC898QIACT
OLEA EUROPAEA LEAFMJ95C3OH47IACT
TRIBASIC CALCIUM PHOSPHATE91D9GV0Z28IACT
SODIUM COCOYL GLUTAMATEBMT4RCZ3HGIACT
SILICON DIOXIDEETJ7Z6XBU4ACTIB

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
469d48d0-49d5-0447-e054-00144ff8d46c5167b6ee-90b7-4066-ae14-e518c7eafe502017-01-21WarningsExact identifier
spl id: 469d48d0-49d5-0447-e054-00144ff8d46c
spl set id: 5167b6ee-90b7-4066-ae14-e518c7eafe50

Reported adverse events (FAERS/openFDA)#

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