FDA.reportPublic FDA data

Oral Fusion Anticavity

Manufacturer
Yangzhou SION Commodity Co.,Ltd
Effective date
2023-12-08
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:03:40

Label at a glance#

ProductOral Fusion Anticavity
Active ingredientSODIUM FLUORIDE
Label structure6 sections

Indications and uses

Help protect against cavities

Dosage and administration

Adult and children 2 years of age and older: Brush teeth thoroughly after meal or at least twice a day, or use as directed by a dentist. Do not swallow To minimizing swallowing, use only a pea sized amount in children under 6 and supervise children's brushing and rinsing to minimize swallowing. Under 2 years: Ask a dentist

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Sodium Fluoride 0.243%

Purpose

OTC - PURPOSE SECTION

anticavity

Uses

INDICATIONS & USAGE SECTION

Help protect against cavities

Warnings

WARNINGS SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

Directions

DOSAGE & ADMINISTRATION SECTION

Adult and children 2 years of age and older:

  • Brush teeth thoroughly after meal or at least twice a day, or use as directed by a dentist.

  • Do not swallow
  • To minimizing swallowing, use only a pea sized amount in children under 6
  • and supervise children's brushing and rinsing to minimize swallowing.

Under 2 years:

  • Ask a dentist

INACTIVE INGREDIENT

INACTIVE INGREDIENT SECTION

Sorbitol, Water, Hydrated Silica, Disodium pyrophosphate, Flavor, Sodium Hydroxide, Xanthan Gum, Cellulose Gum, Hydroxypropyl Guar, Methyl Paraben Sodium, Propyl Paraben Sodium, Sodium Saccharin, Water, Sodium Lauryl Sulfate, CI 778891

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
891775sodium fluoride 0.243 % ToothpastePSN2
891775sodium fluoride 0.00243 MG/MG ToothpasteSCD2
891775sodium fluoride 0.243 % (fluoride ion 0.13 % ) ToothpasteSY2
891775sodium fluoride 0.243 % (fluoride ion 0.14 % ) ToothpasteSY2
891775sodium fluoride 0.243 % (fluoride ion 0.15 % ) ToothpasteSY2
891775sodium fluoride 0.243 % (fluoride ion 0.16 % ) ToothpasteSY2

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70766-010-01Oral Fusion Anticavity24 g in 1 TUBEPASTE, DENTIFRICE242
70766-010-01Oral Fusion Anticavity12 in 1 PACKAGEPASTE, DENTIFRICE122
70766-010-02Oral Fusion Anticavity24 g in 1 TUBEPASTE, DENTIFRICE242
70766-010-02Oral Fusion Anticavity48 in 1 CARTONPASTE, DENTIFRICE482

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70766-010ORAL FUSION ANTICAVITY (SODIUM FLUORIDE) PASTE, DENTIFRICE [YANGZHOU SION COMMODITY CO.,LTD]2Legacy NDC, 4 package rows20231208_ddbbadff-9eb7-4a28-e053-2a95a90a168f.zip

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70766-01070766-010-01, 70766-010-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
SACCHARIN SODIUMSB8ZUX40TYIACT
XANTHAN GUMTTV12P4NEEIACT
SORBITOL506T60A25RIACT
METHYLPARABENA2I8C7HI9TIACT
HYDRATED SILICAY6O7T4G8P9IACT
SODIUM LAURYL SULFATE368GB5141JIACT
PROPYLPARABENZ8IX2SC1OHIACT
WATER059QF0KO0RIACT
SODIUM HYDROXIDE55X04QC32IIACT
HYDROXYPROPYL GUAR (2500-4500 MPA.S AT 1%)3A1I7376TCIACT
SODIUM PYROPHOSPHATEO352864B8ZIACT
SODIUM FLUORIDE8ZYQ1474W7ACTIM

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
0bf9163b-29af-ac40-e063-6394a90a1649ddbbadff-9eb7-4a28-e053-2a95a90a168f2023-12-08WarningsExact identifier
spl id: 0bf9163b-29af-ac40-e063-6394a90a1649
spl set id: ddbbadff-9eb7-4a28-e053-2a95a90a168f

Reported adverse events (FAERS/openFDA)#

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