FDA.reportPublic FDA data

Plak Smacker DINOSAUR ANTI-CAVITY FLUORIDE GEL TOOTHPASTE

Manufacturer
YOUNG PS ACQUISITION, LLC
Effective date
2023-10-16
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:02:36

Label at a glance#

ProductPlak Smacker Anti Cavity Fluoride
Active ingredientSODIUM FLUORIDE
Label structure10 sections

Dosage and administration

Adults and children 2 years of age and older: Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or physician. Do not swallow To minimize swallowing use a pea sized 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 Ingredient

OTC - ACTIVE INGREDIENT SECTION

Sodium Fluoride 0.24% (0.14% w/v Fluoride ion)

Purpose

OTC - PURPOSE SECTION

Anticavity toothpaste

Purpose

OTC - PURPOSE SECTION

Anti-Cavity Toothpaste

Use

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 more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

OTC - DO NOT USE SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • Adults and children 2 years of age and older: Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or physician.
  • Do not swallow
  • To minimize swallowing use a pea sized 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 Ingredients

INACTIVE INGREDIENT SECTION

Sorbitol, Water, Hydrated silica, PEG-32, Cellulose Gum, Sodium Lauryl Sulfate, PEG-6, Flavor, Sodium Saccharin, Methylparaben, Propyparaben, Blue1, Red 33

Questions or comments?

OTC - QUESTIONS SECTION

(800) 558-6684

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PLAK SMACKER®

NO SUGAR ADDED

DINOSAUR

BUBBLE GUM FLAVOR

ANTI-CAVITY FLUORIDE GEL TOOTHPASTE

NET WT. 4.2 oz (119g)

Dinosaur_image.jpgDinosaur_image.jpgDinosaur_small_image.jpgDinosaur_small_image.jpg

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
72326-8002-12023-11-21C16284748780-19d75b9d0-8f0b-f424-e053-dadaa90a57cePlak Smacker DINOSAUR ANTI-CAVITY FLUORIDE GEL TOOTHPASTE
72326-8002-22023-11-21C16284748780-19d75b9d0-8f0b-f424-e053-dadaa90a57cePlak Smacker DINOSAUR ANTI-CAVITY FLUORIDE GEL TOOTHPASTE
72326-8002-32023-11-21C16284748780-19d75b9d0-8f0b-f424-e053-dadaa90a57cePlak Smacker DINOSAUR ANTI-CAVITY FLUORIDE GEL TOOTHPASTE
72326-8002-12020-01-31C16284748780-19d75b9d0-8f0b-f424-e053-dadaa90a57cePlak Smacker DINOSAUR ANTI-CAVITY FLUORIDE GEL TOOTHPASTE
72326-8002-22020-01-31C16284748780-19d75b9d0-8f0b-f424-e053-dadaa90a57cePlak Smacker DINOSAUR ANTI-CAVITY FLUORIDE GEL TOOTHPASTE
72326-8002-32020-01-31C16284748780-19d75b9d0-8f0b-f424-e053-dadaa90a57cePlak Smacker DINOSAUR ANTI-CAVITY FLUORIDE GEL TOOTHPASTE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72326-8002-1Plak Smacker Anti Cavity Fluoride24 g in 1 TUBEPASTE242
72326-8002-2Plak Smacker Anti Cavity Fluoride120 g in 1 TUBEPASTE1202
72326-8002-3Plak Smacker Anti Cavity Fluoride24 g in 1 TUBEPASTE242

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72326-8002PLAK SMACKER ANTI CAVITY FLUORIDE (SODIUM FLUORIDE) PASTE [YOUNG PS ACQUISITION, LLC]2Current NDC, Legacy NDC, 3 package rows20231122_c6dee5fa-9cd4-4a94-9cbe-e977b2bd3dfe.zip

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72326-800272326-8002-1, 72326-8002-2, 72326-8002-3

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
NameUNIIKind
POLYETHYLENE GLYCOL 1450OJ4Z5Z32L4IACT
HYDRATED SILICAY6O7T4G8P9IACT
SACCHARIN SODIUMSB8ZUX40TYIACT
WATER059QF0KO0RIACT
SODIUM LAURYL SULFATE368GB5141JIACT
SORBITOL506T60A25RIACT
SODIUM FLUORIDE8ZYQ1474W7ACTIM
POLYETHYLENE GLYCOL 3005655G9Y8AQIACT
CARBOXYMETHYLCELLULOSE05JZI7B19XIACT
PROPYLPARABENZ8IX2SC1OHIACT
METHYLPARABENA2I8C7HI9TIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
D&C RED NO. 339DBA0SBB0LIACT

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
Plak Smacker Anti Cavity FluorideSODIUM FLUORIDEYOUNG PS ACQUISITION, LLCc6dee5fa-9cd4-4a94-9cbe-e977b2bd3dfe2023-10-16WarningsExact identifier
ndc (package): 72326-8002-1
ndc (package): 72326-8002-3
ndc (package): 72326-8002-2
ndc (product): 72326-8002
ndc11 (package): 72326800203
ndc11 (package): 72326800202
ndc11 (package): 72326800201
spl id: 07d5baa5-6b43-e0fa-e063-6394a90a9565
spl set id: c6dee5fa-9cd4-4a94-9cbe-e977b2bd3dfe

Reported adverse events (FAERS/openFDA)#

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