FDA.reportPublic FDA data

Osstem G Gum Health Care Toothpaste

Manufacturer
Osstem Pharma Co., Ltd | DONG IL PHARMS CO., LTD.
Effective date
2026-04-15
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:53:56

Label at a glance#

ProductOsstem G Gum Health Care Tooth
Active ingredientSODIUM FLUORIDE
Label structure10 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredients

Sodium Fluoride 0.22%

OTC - PURPOSE SECTION

Purpose

Anticavity

INDICATIONS & USAGE SECTION

Uses

Aids in the prevention of dental cavities

WARNINGS SECTION

Warnings

Keep out of 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

.

DOSAGE & ADMINISTRATION SECTION

Directions

■ 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

■ Instruct children under 6 years of age in good brushing and rinsing habits (to minimize swallowing) ■ Supervise children as necessary until capable of using without supervision.

■ Children under 2 years : Consult a dentist or doctor.

OTHER SAFETY INFORMATION

Other Information

Store at 1~30°C (34~86°F)

OTC - QUESTIONS SECTION

Questions

+82-1660-0675

info@osstempharma.com

INACTIVE INGREDIENT SECTION

Inactive ingredients

Sorbitol, Silica, Water, Glycerin, Sodium Lauryl Sulfate, Cellulose Gum, PEG-32, Menthol, Potassium Acesulfame, Tocopheryl Acetate, Xylitol, Panthenol, Centella Asiatica Extract, Citral, d-Limonene, Linalool

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Carton ImageCarton Image

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
245598sodium fluoride 0.22 % ToothpastePSN1
245598sodium fluoride 0.0022 MG/MG ToothpasteSCD1
245598sodium fluoride 0.22 % (fluoride 0.1 % ) ToothpasteSY1

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
87548-020-01Osstem G Gum Health Care Tooth120 g in 1 TUBEPASTE, DENTIFRICE1201
87548-020-02Osstem G Gum Health Care Tooth1 in 1 CARTONPASTE, DENTIFRICE11

Products#

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

DailyMed product names page 1 of 1 · 19 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
87548-02087548-020-01, 87548-020-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 17 matching rows.

Name, UNII, Kind table
NameUNIIKind
PEG-321212Z7S33AIACT
SODIUM FLUORIDE8ZYQ1474W7ACTIM
LINALOOLD81QY6I88EIACT
CELLULOSE GUMK679OBS311IACT
XYLITOLVCQ006KQ1EIACT
CENTELLA ASIATICA TRITERPENOIDS4YS74Q4G4JIACT
LIMONENE, (+)-GFD7C86Q1WIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
SODIUM LAURYL SULFATE368GB5141JIACT
GLYCERINPDC6A3C0OXIACT
MENTHOLL7T10EIP3AIACT
POTASSIUM ACESULFAME23OV73Q5G9IACT
ALPHA-TOCOPHEROL ACETATE9E8X80D2L0IACT
PANTHENOLWV9CM0O67ZIACT
WATER059QF0KO0RIACT
CITRALT7EU0O9VPPIACT
SORBITOL506T60A25RIACT

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
Osstem G Gum Health Care ToothSODIUM FLUORIDEOsstem Pharma Co., Ltd4f8b4fc0-4c98-5e52-e063-6394a90af7102026-04-15WarningsExact identifier
ndc (package): 87548-020-01
ndc (package): 87548-020-02
ndc (product): 87548-020
ndc11 (package): 87548002001
ndc11 (package): 87548002002
spl id: 4f8b4fc0-4c99-5e52-e063-6394a90af710
spl set id: 4f8b4fc0-4c98-5e52-e063-6394a90af710

Reported adverse events (FAERS/openFDA)#

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