FDA.reportPublic FDA data

ATOMY PROPOLIS TOOTHPAS TE 50G

Manufacturer
ATOMY CO., LTD. | Kolmar Korea Co.,LTD. Gwanjeong 2 factory
Effective date
2024-01-30
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 00:08:01

Label at a glance#

ProductATOMY PROPOLIS TOOTHPAS TE 50G
Active ingredientSODIUM MONOFLUOROPHOSPHATE, SODIUM FLUORIDE
Label structure9 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient: Sodium Monofluorophosphate 0.16%, Sodium Fluoride 0.10%

INACTIVE INGREDIENT SECTION

Inactive Ingredients: SORBITOL, HYDRATED SILICA, WATER, SILICA, SODIUM LAURYL SULFATE, TETRASODIUM PYROPHOSPHATE, PEG-32, CELLULOSE GUM, CITRUS FLAVOR, CITRUS AURANTIUM DULCIS(ORANGE) PEEL OIL, MINT FLAVOR, SODIUM SACCHARIN, XYLITOL, CAMELLIA SINENSIS EXTRACT, MENTHOL, PROPOLIS EXTRACT

OTC - PURPOSE SECTION

Purpose: Anticaries

WARNINGS SECTION

Warnings:
Ask a doctor before use if you have:
Bleeding or redness lasting more than 2 weeks.
Pain, swelling, pus, loose teeth, or more spacing between teeth.
These may be signs of periodontitis, a serious form of gum disease.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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.

DOSAGE & ADMINISTRATION SECTION

Directions:
1) Adults and children 2 years of age and older: Brush teeth throughly preferably after each meal or at least twice a day or as directed by a dentist or doctor. 2) Children under 6 years: To minimize swallowing, use a pea-sized amount and supervise brushing until good habits are established. 3) Children under 2 years: Consult a dentist or doctor.

INDICATIONS & USAGE SECTION

Uses:
Aids in the prevention of dental cavities.

OTC - QUESTIONS SECTION

Questions?
1-253-946-2344

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of cartonImage of cartonImage of cartonImage of carton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1046867sodium monofluorophosphate 0.16 % / sodium fluoride 0.1 % ToothpastePSN5
1046867sodium fluoride 0.001 MG/MG / sodium monofluorophosphate 0.0016 MG/MG ToothpasteSCD5
1046867sodium fluoride 0.1 % / sodium monofluorophosphate 0.16 % ToothpasteSY5

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52257-1380-1ATOMY PROPOLIS TOOTHPAS TE 50G50 g in 1 TUBEPASTE, DENTIFRICE505
52257-1380-2ATOMY PROPOLIS TOOTHPAS TE 50G4 in 1 CARTONPASTE, DENTIFRICE45

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52257-1380ATOMY PROPOLIS TOOTHPAS TE 50G (SODIUM MONOFLUOROPHOSPHATE, SODIUM FLUORIDE) PASTE, DENTIFRICE [ATOMY CO., LTD.]5Current NDC, Legacy NDC, 2 package rows20240130_98d839e3-a1aa-c83d-e053-2995a90a7e79.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
52257-138052257-1380-1, 52257-1380-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
SODIUM MONOFLUOROPHOSPHATEC810JCZ56QACTIM
SODIUM FLUORIDE8ZYQ1474W7ACTIM
SILICON DIOXIDEETJ7Z6XBU4IACT
HYDRATED SILICAY6O7T4G8P9IACT
WATER059QF0KO0RIACT
SODIUM LAURYL SULFATE368GB5141JIACT
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
ATOMY PROPOLIS TOOTHPAS TE 50GSODIUM MONOFLUOROPHOSPHATE, SODIUM FLUORIDEATOMY CO., LTD.98d839e3-a1aa-c83d-e053-2995a90a7e792024-01-30WarningsExact identifier
ndc (package): 52257-1380-2
ndc (package): 52257-1380-1
ndc (product): 52257-1380
ndc11 (package): 52257138002
ndc11 (package): 52257138001
spl id: bf9632ba-2fdb-4d32-b069-b2533e94f974
spl set id: 98d839e3-a1aa-c83d-e053-2995a90a7e79

Reported adverse events (FAERS/openFDA)#

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