FDA.reportPublic FDA data

Plak Smacker Great White Shark Cool Berry Flavor Anti Cavity Fluoride Gel Tooth

Manufacturer
Yangzhou SION Commodity Co.,Ltd
Effective date
2024-07-29
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:16:11

Label at a glance#

ProductPlak Smacker Great White Shark Cool Berry Flavor Anti Cavity Fluoride Gel Tooth
Active ingredientSODIUM FLUORIDE
Label structure6 sections

Indications and uses

Aids in the prevention of 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 physician Do not swallow To minimize wallowing, use a pea sizes amount in children under 6 years Supervise children's brushing until 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% (0.10 w/v Fluoride ion)

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

Anti-cavity toothpaste

Uses

INDICATIONS & USAGE SECTION

Aids in the prevention of 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.

Do not use if the inner foil is torn, cut, or missing

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 physician
  • Do not swallow
  • To minimize wallowing, use a pea sizes amount in children under 6 years
  • Supervise children's brushing until 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, Cellulose gum, Xanthan gum, flavor, Xylitol, Sodium saccharin, Sodium benzoate, Trisodium phosphate, CI 42090

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
416783sodium fluoride 0.24 % ToothpastePSN2
416783sodium fluoride 0.0024 MG/MG ToothpasteSCD2
416783sodium fluoride 0.24 % (fluoride ion 0.13 % ) ToothpasteSY2
416783sodium fluoride 0.24 % (fluoride ion 0.14 % ) ToothpasteSY2
416783sodium fluoride 0.24 % (fluoride ion 0.15 % ) ToothpasteSY2

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70766-012-01Plak Smacker Great White Shark Cool Berry Flavor Anti Cavity Fluoride Gel Tooth24 g in 1 TUBEPASTE, DENTIFRICE242
70766-012-01Plak Smacker Great White Shark Cool Berry Flavor Anti Cavity Fluoride Gel Tooth144 in 1 BOXPASTE, DENTIFRICE1442
70766-012-02Plak Smacker Great White Shark Cool Berry Flavor Anti Cavity Fluoride Gel Tooth5 in 1 CARTONPASTE, DENTIFRICE52
70766-012-02Plak Smacker Great White Shark Cool Berry Flavor Anti Cavity Fluoride Gel Tooth24 in 1 BOXPASTE, DENTIFRICE242
70766-012-03Plak Smacker Great White Shark Cool Berry Flavor Anti Cavity Fluoride Gel Tooth144 in 1 BOXPASTE, DENTIFRICE1442
70766-012-03Plak Smacker Great White Shark Cool Berry Flavor Anti Cavity Fluoride Gel Tooth50 g in 1 TUBEPASTE, DENTIFRICE502
70766-012-04Plak Smacker Great White Shark Cool Berry Flavor Anti Cavity Fluoride Gel Tooth72 in 1 BOXPASTE, DENTIFRICE722
70766-012-04Plak Smacker Great White Shark Cool Berry Flavor Anti Cavity Fluoride Gel Tooth100 g in 1 TUBEPASTE, DENTIFRICE1002
70766-012-05Plak Smacker Great White Shark Cool Berry Flavor Anti Cavity Fluoride Gel Tooth100 g in 1 TUBEPASTE, DENTIFRICE1002
70766-012-05Plak Smacker Great White Shark Cool Berry Flavor Anti Cavity Fluoride Gel Tooth144 in 1 BOXPASTE, DENTIFRICE1442
70766-012-06Plak Smacker Great White Shark Cool Berry Flavor Anti Cavity Fluoride Gel Tooth28 g in 1 TUBEPASTE, DENTIFRICE282
70766-012-06Plak Smacker Great White Shark Cool Berry Flavor Anti Cavity Fluoride Gel Tooth480 in 1 BOXPASTE, DENTIFRICE4802
70766-012-07Plak Smacker Great White Shark Cool Berry Flavor Anti Cavity Fluoride Gel Tooth72 in 1 BOXPASTE, DENTIFRICE722
70766-012-07Plak Smacker Great White Shark Cool Berry Flavor Anti Cavity Fluoride Gel Tooth120 g in 1 TUBEPASTE, DENTIFRICE1202
70766-012-08Plak Smacker Great White Shark Cool Berry Flavor Anti Cavity Fluoride Gel Tooth144 in 1 BOXPASTE, DENTIFRICE1442
70766-012-08Plak Smacker Great White Shark Cool Berry Flavor Anti Cavity Fluoride Gel Tooth120 g in 1 TUBEPASTE, DENTIFRICE1202
70766-012-09Plak Smacker Great White Shark Cool Berry Flavor Anti Cavity Fluoride Gel Tooth12 in 1 BOXPASTE, DENTIFRICE122
70766-012-09Plak Smacker Great White Shark Cool Berry Flavor Anti Cavity Fluoride Gel Tooth119 g in 1 TUBEPASTE, DENTIFRICE1192
70766-012-10Plak Smacker Great White Shark Cool Berry Flavor Anti Cavity Fluoride Gel Tooth12 in 1 BOXPASTE, DENTIFRICE122
70766-012-10Plak Smacker Great White Shark Cool Berry Flavor Anti Cavity Fluoride Gel Tooth72 in 1 CARTONPASTE, DENTIFRICE722

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70766-012PLAK SMACKER GREAT WHITE SHARK COOL BERRY FLAVOR ANTI CAVITY FLUORIDE GEL TOOTH (SODIUM FLUORIDE) PASTE, DENTIFRICE [YANGZHOU SION COMMODITY CO.,LTD]220 package rows20240730_5c005965-ce7f-48b7-96f5-7c7f39b36e37.zip

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70766-01270766-012-01, 70766-012-02, 70766-012-06, 70766-012-03, 70766-012-04, 70766-012-05, 70766-012-07, 70766-012-08, 70766-012-09, 70766-012-10

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
SORBITOL506T60A25RIACT
HYDRATED SILICAY6O7T4G8P9IACT
SODIUM LAURYL SULFATE368GB5141JIACT
XANTHAN GUMTTV12P4NEEIACT
TRISODIUM PHOSPHIDEA360RQX9W2IACT
SODIUM BENZOATEOJ245FE5EUIACT
XYLITOLVCQ006KQ1EIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
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
1e698d8b-ac66-21e5-e063-6394a90ad9125c005965-ce7f-48b7-96f5-7c7f39b36e372024-07-29WarningsExact identifier
spl id: 1e698d8b-ac66-21e5-e063-6394a90ad912
spl set id: 5c005965-ce7f-48b7-96f5-7c7f39b36e37

Reported adverse events (FAERS/openFDA)#

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