FDA.reportPublic FDA data

DawnMist Fluoride Tooth

Manufacturer
Yangzhou SION Commodity Co.,Ltd
Effective date
2024-04-29
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:11:37

Label at a glance#

ProductDawnMist Fluoride Tooth
Active ingredientSODIUM FLUORIDE
Label structure6 sections

Indications and uses

Aids in the prevention of dental cavities.

Dosage and administration

Do not swallow, supervise children as necessary until capable of using without supervision. Instruct children under 12 years of age in good brushing and rinsing habits (to minimizing swallowing).  Adults and children 6 years of age and older: Brush teeth thoroughly, preferrably after each meal or at least twice a day, or as directed by a dentist or a doctor. Children under 6 years of age: Do not use unless directe...

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

SODIUM FLUORIDE   0.22%(0.10 w/v Fluoride ion)

<text xmlns="urn:hl7-org:v3"> <paragraph>SODIUM FLUORIDE   0.24%(0.11 w/v Fluoride ion)</paragraph> <paragraph/>&lt;text xmlns="urn:hl7-org:v3"> &lt;paragraph>SODIUM FLUORIDE   0.24%(0.11 w/v Fluoride ion)&lt;/paragraph> &lt;paragraph/>&amp;lt;text xmlns="urn:hl7-org:v3"> &amp;lt;paragraph>SODIUM FLUORIDE   0.24%(0.10 w/v Fluoride ion)&amp;lt;/paragraph> &amp;lt;paragraph/>&amp;amp;lt;text xmlns="urn:hl7-org:v3"> &amp;amp;lt;paragraph>SODIUM FLUORIDE   0.24%(0.10 w/v Fluoride ion)&amp;amp;lt;/paragraph> &amp;amp;lt;paragraph/>&amp;amp;amp;lt;text xmlns="urn:hl7-org:v3"> &amp;amp;amp;lt;paragraph>SODIUM FLUORIDE   0.24%(0.10 w/v Fluoride ion)&amp;amp;amp;lt;/paragraph> &amp;amp;amp;lt;paragraph/> &amp;amp;amp;lt;/text>&amp;amp;lt;/text>&amp;lt;/text>&lt;/text></text>

Purpose

OTC - PURPOSE SECTION

Anticavity

Uses

INDICATIONS & USAGE SECTION

Aids in the prevention of dental cavities.

Warnings

WARNINGS SECTION

Keep out of the reach of children under 6 years of age. If you accidently swallow more than used for brushing, 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

  • Do not swallow, supervise children as necessary until capable of using without supervision. Instruct children under 12 years of age in good brushing and rinsing habits (to minimizing swallowing). 
  • Adults and children 6 years of age and older: Brush teeth thoroughly, preferrably after each meal or at least twice a day, or as directed by a dentist or a doctor.
  • Children under 6 years of age: Do not use unless directed by a doctor or dentist.

INACTIVE INGREDIENT

INACTIVE INGREDIENT SECTION

Calcium Carbonate, Water, Sorbitol, PEG-400, Sodium Lauryl Sulfate, Hydrated Silica, Cellulose Gum, Flavor, Hydroxypropyl Guar, , Sodium Sacharine, Methylparaben, Propylparaben

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

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
70766-015-01DawnMist Fluoride Tooth144 in 1 BOXPASTE, DENTIFRICE1441
70766-015-01DawnMist Fluoride Tooth5 in 1 CARTONPASTE, DENTIFRICE51
70766-015-02DawnMist Fluoride Tooth144 in 1 BOXPASTE, DENTIFRICE1441
70766-015-02DawnMist Fluoride Tooth5 in 1 CARTONPASTE, DENTIFRICE51
70766-015-03DawnMist Fluoride Tooth144 in 1 BOXPASTE, DENTIFRICE1441
70766-015-03DawnMist Fluoride Tooth43 g in 1 TUBEPASTE, DENTIFRICE431
70766-015-04DawnMist Fluoride Tooth78 g in 1 TUBEPASTE, DENTIFRICE781
70766-015-04DawnMist Fluoride Tooth144 in 1 BOXPASTE, DENTIFRICE1441
70766-015-05DawnMist Fluoride Tooth60 in 1 BOXPASTE, DENTIFRICE601
70766-015-05DawnMist Fluoride Tooth135 g in 1 TUBEPASTE, DENTIFRICE1351
70766-015-06DawnMist Fluoride Tooth48 in 1 BOXPASTE, DENTIFRICE481
70766-015-06DawnMist Fluoride Tooth181.4 g in 1 TUBEPASTE, DENTIFRICE181.41

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70766-015DAWNMIST FLUORIDE TOOTH (SODIUM FLUORIDE) PASTE, DENTIFRICE [YANGZHOU SION COMMODITY CO.,LTD]112 package rows20240430_6c72752d-eafa-4418-9d0e-aa41a6ba0bde.zip

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70766-01570766-015-01, 70766-015-02, 70766-015-03, 70766-015-04, 70766-015-05, 70766-015-06

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
SORBITOL506T60A25RIACT
HYDRATED SILICAY6O7T4G8P9IACT
SODIUM LAURYL SULFATE368GB5141JIACT
METHYLPARABENA2I8C7HI9TIACT
PROPYLPARABENZ8IX2SC1OHIACT
CALCIUM CARBONATEH0G9379FGKIACT
HYDROXYPROPYL GUAR (2500-4500 MPA.S AT 1%)3A1I7376TCIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
SODIUM FLUORIDE8ZYQ1474W7ACTIB

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
1742e32b-9c5b-666f-e063-6294a90a18e16c72752d-eafa-4418-9d0e-aa41a6ba0bde2024-04-29WarningsExact identifier
spl id: 1742e32b-9c5b-666f-e063-6294a90a18e1
spl set id: 6c72752d-eafa-4418-9d0e-aa41a6ba0bde

Reported adverse events (FAERS/openFDA)#

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