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

Key Label Information#

Active Ingredients And Purpose

Active Ingredient

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

Purpose

Anti-Cavity Toothpaste

Uses

Use

Aids in the prevention of dental cavities.

Warnings

Warnings

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 - DO NOT USE SECTION

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

Directions And Dosage

Directions

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.

Other Label Information

Inactive Ingredients

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

Questions or comments?

(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)

Label Images#

Dinosaur_image
Dinosaur_image
Dinosaur_small_image
Dinosaur_small_image

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#

NDC Codes#

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

Ingredients#

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

Complete SPL Sections#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

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

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

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

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

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)

Source Document#

Source XML