FDA.reportPublic FDA data

70766-016 Dinosuair anticavity gel tooth paste

Manufacturer
Yangzhou SION Commodity Co.,Ltd
Effective date
2024-07-21
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:15:43

Label at a glance#

ProductDINOSAUR BUBBLE GUM FLAVOR ANTI-CAVITY FLUORIDE TOOTH
Active ingredientSODIUM FLUORIDE
Label structure6 sections

Indications and uses

Aids in the prevention of dental cavities.

Dosage and administration

Adults and children 2 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. Do not swallow To minimize swallowing, use a pea sized amount in children under 6 years Supervise children brushing untill good habits are established Children under 2 years of age: Consult a dentist or physician.

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

SODIUM FLUORIDE   0.24%(0.14 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

  • Adults and children 2 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.
  • Do not swallow
  • To minimize swallowing, use a pea sized amount in children under 6 years
  • Supervise children brushing untill good habits are established
  • Children under 2 years of age: Consult a dentist or physician.

INACTIVE INGREDIENT

INACTIVE INGREDIENT SECTION

Sorbitol,, Water, Silica, PEG-400, Sodium Lauryl Sulfate, Flavor, Cellulose Gum, Xanthan Gum, Xylitor, Sodium Sacharine, Sodium Benzoate, Sodium Phosphate, CI 42090, CI 19140

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
416783sodium fluoride 0.24 % ToothpastePSN1
416783sodium fluoride 0.0024 MG/MG ToothpasteSCD1
416783sodium fluoride 0.24 % (fluoride ion 0.13 % ) ToothpasteSY1
416783sodium fluoride 0.24 % (fluoride ion 0.14 % ) ToothpasteSY1
416783sodium fluoride 0.24 % (fluoride ion 0.15 % ) ToothpasteSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70766-016-012026-01-29C16284748780-149896155-c97d-586f-e063-e6dba90add9070766-016 Dinosuair anticavity gel tooth paste
70766-016-022026-01-29C16284748780-149896155-c97d-586f-e063-e6dba90add9070766-016 Dinosuair anticavity gel tooth paste
70766-016-032026-01-29C16284748780-149896155-c97d-586f-e063-e6dba90add9070766-016 Dinosuair anticavity gel tooth paste
70766-016-042026-01-29C16284748780-149896155-c97d-586f-e063-e6dba90add9070766-016 Dinosuair anticavity gel tooth paste
70766-016-052026-01-29C16284748780-149896155-c97d-586f-e063-e6dba90add9070766-016 Dinosuair anticavity gel tooth paste

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70766-016-01DINOSAUR BUBBLE GUM FLAVOR ANTI-CAVITY FLUORIDE TOOTH24 g in 1 TUBEPASTE, DENTIFRICE241
70766-016-01DINOSAUR BUBBLE GUM FLAVOR ANTI-CAVITY FLUORIDE TOOTH144 in 1 BOXPASTE, DENTIFRICE1441
70766-016-02DINOSAUR BUBBLE GUM FLAVOR ANTI-CAVITY FLUORIDE TOOTH144 in 1 BOXPASTE, DENTIFRICE1441
70766-016-02DINOSAUR BUBBLE GUM FLAVOR ANTI-CAVITY FLUORIDE TOOTH4 in 1 CARTONPASTE, DENTIFRICE41
70766-016-03DINOSAUR BUBBLE GUM FLAVOR ANTI-CAVITY FLUORIDE TOOTH96 in 1 BOXPASTE, DENTIFRICE961
70766-016-03DINOSAUR BUBBLE GUM FLAVOR ANTI-CAVITY FLUORIDE TOOTH24 g in 1 TUBEPASTE, DENTIFRICE241
70766-016-04DINOSAUR BUBBLE GUM FLAVOR ANTI-CAVITY FLUORIDE TOOTH12 in 1 BOXPASTE, DENTIFRICE121
70766-016-04DINOSAUR BUBBLE GUM FLAVOR ANTI-CAVITY FLUORIDE TOOTH119 g in 1 TUBEPASTE, DENTIFRICE1191
70766-016-05DINOSAUR BUBBLE GUM FLAVOR ANTI-CAVITY FLUORIDE TOOTH6 in 1 CARTONPASTE, DENTIFRICE61
70766-016-05DINOSAUR BUBBLE GUM FLAVOR ANTI-CAVITY FLUORIDE TOOTH12 in 1 BOXPASTE, DENTIFRICE121

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70766-016DINOSAUR BUBBLE GUM FLAVOR ANTI-CAVITY FLUORIDE TOOTH (SODIUM FLUORIDE) PASTE, DENTIFRICE [YANGZHOU SION COMMODITY CO.,LTD]110 package rows20240722_cccb3122-891b-4168-81ee-d8e97706caee.zip

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70766-01670766-016-01, 70766-016-02, 70766-016-03, 70766-016-04, 70766-016-05

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
SORBITOL506T60A25RIACT
HYDRATED SILICAY6O7T4G8P9IACT
SODIUM LAURYL SULFATE368GB5141JIACT
CALCIUM CARBONATEH0G9379FGKIACT
POLYETHYLENE GLYCOL 400B697894SGQIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
SODIUM BENZOATEOJ245FE5EUIACT
XYLITOLVCQ006KQ1EIACT
CARBOXYMETHYLCELLULOSE SODIUMK679OBS311IACT
FD&C BLUE NO. 1H3R47K3TBDIACT
FD&C YELLOW NO. 5I753WB2F1MIACT
SODIUM PHOSPHATESE337SVY37IACT
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
1dcb7496-3568-b639-e063-6394a90ab703cccb3122-891b-4168-81ee-d8e97706caee2024-07-21WarningsExact identifier
spl id: 1dcb7496-3568-b639-e063-6394a90ab703
spl set id: cccb3122-891b-4168-81ee-d8e97706caee

Reported adverse events (FAERS/openFDA)#

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