FDA.reportPublic FDA data

Tooth

Manufacturer
Henan Dailygreen Biotechnology Co. LTD
Effective date
2024-12-25
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 20:44:18

Label at a glance#

ProductTooth
Active ingredientSODIUM MONOFLUOROPHOSPHATE
Label structure12 sections

Dosage and administration

Crush the tab between your teeth. Brush like normal for 2 minutes and spit out.Brush preferably after each meal, or at least twice a day, or as directed by your dentist. DO NOT SWALLOW.Children under the age of6 - DO NOT USE

Storage and handling

Store the toothpaste tabs in our refill pack in a cool and dry place or airtight in our glass storage bottle or in another airtight bottle or box.

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Sodium monofluorophosphate 1,1%(1450ppm)

Purpose

OTC - PURPOSE SECTION

Anti-cavity

Use

INDICATIONS & USAGE SECTION

Aids in the prevention of dental cavities

Warnings

WARNINGS SECTION

Use this product only for brushing your teeth.Do not swallow the toothpaste tabiets. Keep out of reach of children under 6 years of age and out of reach of pets. If more than used for brushing is accidentally swallowed, get medical help or contact a poison control center right away.

OTC - DO NOT USE SECTION

Do not swallow the toothpaste tabiets.

OTC - WHEN USING SECTION

n/a

OTC - STOP USE SECTION

n/a

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children under 6 years of age and out of reach of pets.

Directions

DOSAGE & ADMINISTRATION SECTION

Crush the tab between your teeth. Brush like normal for 2 minutes and spit out.Brush preferably after each meal, or at least twice a day, or as directed by your dentist. DO NOT SWALLOW.Children under the age of6 - DO NOT USE

Other Information

STORAGE AND HANDLING SECTION

Store the toothpaste tabs in our refill pack in a cool and dry place or airtight in our glass storage bottle or in another airtight bottle or box.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Sorbitol,Calcium carbonate, Yeast, hydroxyapatite, acacia senegal gum extract, sodium coco sulfate, hydrated silica, Mentha arvensis leaf oil, magnesium stearate, limonene, mentha viridis leaf oil, stevioside, menthol, mentha piperita oil

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

83861-004-0183861-004-01

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
83861-00483861-004-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Name, UNII, Kind table
NameUNIIKind
CALCIUM CARBONATEH0G9379FGKIACT
MENTHA ARVENSIS LEAF OIL1AEY1M553NIACT
SODIUM COCO-SULFATE3599J29ANHIACT
YEAST3NY3SM6B8UIACT
ACACIA SENEGAL GUM5C5403N26OIACT
MENTHOLL7T10EIP3AIACT
STEVIOSIDE0YON5MXJ9PIACT
MENTHA VIRIDIS (SPEARMINT) LEAF OILC3M81465G5IACT
MENTHA PIPERITA (PEPPERMINT) OILAV092KU4JHIACT
HYDRATED SILICAY6O7T4G8P9IACT
SORBITOL506T60A25RIACT
SODIUM MONOFLUOROPHOSPHATEC810JCZ56QACTIM
LIMONENE, (+)-GFD7C86Q1WIACT
HYDROXYAPATITE91D9GV0Z28IACT
MAGNESIUM STEARATE70097M6I30IACT

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
2ac88ff5-7872-0646-e063-6394a90a70012a140fee-88cb-8a9d-e063-6394a90a01ef2025-01-03WarningsExact identifier
spl set id: 2a140fee-88cb-8a9d-e063-6394a90a01ef

Reported adverse events (FAERS/openFDA)#

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