FDA.reportPublic FDA data

Olidental Gargle

Manufacturer
AJU PHARM CO., LTD.
Effective date
2016-01-20
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:44:41

Label at a glance#

ProductOlidental Gargle
Active ingredientSODIUM FLUORIDE
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Sodium Fluoride 0.02%

OTC - PURPOSE SECTION

Anticavity

INDICATIONS & USAGE SECTION

Aids in the prevention of dental cavities

DOSAGE & ADMINISTRATION SECTION

Adults and children 12 years of age and older:
• Use twice daily after brushing your teeth with a toothpaste
• Vigorously swish 10mL (2 teaspoonfuls) of rinse between your teeth for 1 minute and then spit out
• Do not swallow the rinse
• Do not eat or drink for 30 minutes after rinsing
• Supervise children as necessary until capable of suing without supervisor

Children under 12 years of age: consult a dentist or doctor

WARNINGS SECTION

Stop use and ask a dentist if oral irritation or tooth sensitivity occurs

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

INACTIVE INGREDIENT SECTION

Glycerin, Allantoin, Xylitol, Stevioside, Acetic acid, Sodium bicarbonate, Sodium acetate, Olive leaf extract, Sodium Benzoate, Green Tea Extract, Sodium Saccharin, L-Menthol, Citrus flavoring, Lemon flavoring, Propolis Extract, Lemon Oil, Cacao Color, Purified water

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
313029sodium fluoride 0.02 % (fluoride ion 0.01 % ) Oral RinsePSN1
313029sodium fluoride 0.2 MG/ML MouthwashSCD1
313029sodium fluoride 0.02 % (fluoride ion 0.009 % ) Oral RinseSY1
313029sodium fluoride 0.02 % (fluoride ion 0.01 % ) Oral RinseSY1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
48747306-602a-42cc-957b-5b0c69158eeeProduct name120180604
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
db5ebcdb-b6ae-21cd-4dc5-76cd84b5578bProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70417-001-012020-01-31C16284748780-19d75b9d0-5410-f424-e053-dadaa90a57ceDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70417-001-01Olidental Gargle300 mL in 1 BOTTLELIQUID3001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70417-001OLIDENTAL GARGLE (SODIUM FLUORIDE) LIQUID [AJU PHARM CO., LTD.]1Legacy NDC, 1 package rows20160122_71f907b8-8f28-4fd2-a035-b79cbf9ab860.zip

Products#

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

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70417-00170417-001-01

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
SODIUM FLUORIDE8ZYQ1474W7ACTIM
GLYCERINPDC6A3C0OXIACT
ALLANTOIN344S277G0ZIACT
XYLITOLVCQ006KQ1EIACT
STEVIOSIDE0YON5MXJ9PIACT
ACETIC ACIDQ40Q9N063PIACT
SODIUM BICARBONATE8MDF5V39QOIACT
SODIUM ACETATE4550K0SC9BIACT
OLEA EUROPAEA LEAFMJ95C3OH47IACT
SODIUM BENZOATEOJ245FE5EUIACT
GREEN TEA LEAFW2ZU1RY8B0IACT
SACCHARIN SODIUMSB8ZUX40TYIACT
LEVOMENTHOLBZ1R15MTK7IACT
PROPOLIS WAX6Y8XYV2NOFIACT
LEMON OILI9GRO824LLIACT
WATER059QF0KO0RIACT

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
f6e97c6c-a3a0-4054-822c-4c02a1d6e4e671f907b8-8f28-4fd2-a035-b79cbf9ab8602016-01-20WarningsExact identifier
spl id: f6e97c6c-a3a0-4054-822c-4c02a1d6e4e6
spl set id: 71f907b8-8f28-4fd2-a035-b79cbf9ab860

Reported adverse events (FAERS/openFDA)#

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