FDA.reportPublic FDA data

DenTek Looney Tunes Kids

Manufacturer
DenTek Oral Care, Inc. | Goran Pharma Pvt. Ltd.
Effective date
2016-02-08
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 22:44:55

Label at a glance#

ProductDenTek Looney Tunes Kids Bubblegum Blast
Active ingredientSODIUM FLUORIDE
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients:

Sodium Fluoride 0.22% (0.126% w/v Fluoride Ion)

OTC - PURPOSE SECTION

Purpose:

Anticavity

INDICATIONS & USAGE SECTION

Use:

Helps protect against cavities

WARNINGS SECTION

Warnings:

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children under 6 years of age.

DOSAGE & ADMINISTRATION SECTION

Directions: . Adults and children 2 years of age and older: brush teeth thoroughly after meals or at least twice a day or use as directed by a dentist .Children 2 to 6 years: use only a pea sized amount and supervise child's brushing and rinsing (to minimize swallowing) .Children under 2 years: ask a dentist or physician

INACTIVE INGREDIENT SECTION

Inactive Ingredients: Sorbitol, Water, Hydrated Silica, Sodium Lauryl Sulfate, Cellulose Gum, Flavor, Sodium Phosphate, Sodium Saccharin, Sodium Hydroxide, CI 45430 (FD&C Red No. 3).

OTC - QUESTIONS SECTION

Questions? 1-800-433-6835

toothpaste tube label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Looney toothpaste tube labelLooney toothpaste tube label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
245598sodium fluoride 0.22 % ToothpastePSN3
245598sodium fluoride 0.0022 MG/MG ToothpasteSCD3
245598sodium fluoride 0.22 % (fluoride 0.1 % ) ToothpasteSY3

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130047701003619GTIN-13: 0047701003619
EAN-13: 0047701003619
GTIN-12: 047701003619
UPC-A: 047701003619
GTIN storage (14 digits): 00047701003619		500498A_looney_paste_091113.1.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
60630-498-012020-01-31C16284748780-19d75b9d0-06b2-f424-e053-dadaa90a57ceDenTek Looney Tunes Kids Anticavity Fluoride Toothpaste

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
60630-498-01DenTek Looney Tunes KidsBubblegum Blast76.5 g in 1 TUBEPASTE, DENTIFRICE76.53

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60630-498DENTEK LOONEY TUNES KIDS BUBBLEGUM BLAST (FLUORIDE TOOTHPASTE) PASTE, DENTIFRICE [DENTEK ORAL CARE, INC.]3Legacy NDC, 1 package rows20160208_2b437c41-f6da-1da3-e054-00144ff88e88.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
60630-49860630-498-01

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
SODIUM FLUORIDE8ZYQ1474W7ACTIM
WATER059QF0KO0RIACT
HYDRATED SILICAY6O7T4G8P9IACT
SODIUM PHOSPHATESE337SVY37IACT
SACCHARIN SODIUMSB8ZUX40TYIACT
CARBOXYMETHYLCELLULOSE05JZI7B19XIACT
ERYTHROSINE SODIUM ANHYDROUS8TL7LH93FMIACT
SODIUM LAURYL SULFATE368GB5141JIACT
SODIUM HYDROXIDE55X04QC32IIACT
SORBITOL506T60A25RIACT

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
2b437c41-f6db-1da3-e054-00144ff88e882b437c41-f6da-1da3-e054-00144ff88e882016-02-08WarningsExact identifier
spl id: 2b437c41-f6db-1da3-e054-00144ff88e88
spl set id: 2b437c41-f6da-1da3-e054-00144ff88e88

Reported adverse events (FAERS/openFDA)#

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