FDA.reportPublic FDA data

Close Up Anticavity Toothpaste

Manufacturer
KIK Custom Products
Effective date
2010-03-25
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:23:59

Label at a glance#

ProductClose Up Anticavity Toothpaste
Active ingredientSodium Fluoride
Label structure5 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Drug Facts:

Sodium Fluoride:     0.24%

Purpose:  Anticavity Toothpaste

WARNINGS SECTION

KEEP OUT OF 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.

INACTIVE INGREDIENT SECTION

Sorbitol , Water,  Hydrated Silica, PEG-32,  Sodium Lauryl Sulfate, SD-Alcohol 38B, Flavor, Cellulose Gum, Sodium Saccharin, Red33, Red40

OTC - QUESTIONS SECTION

Questions or Comments ?:  Call 1-800-786-5135 Monday -Friday 9am-5pmET

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of Tube LabelImage of Tube Label

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
61047-770-102020-01-31C16284748780-19d75b9d0-2ff5-f424-e053-dadaa90a57ceClose Up Anticavity Fluoride Toothpaste

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61047-770-10Close Up Anticavity Toothpaste113.4 g in 1 TUBEGEL113.41

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61047-770CLOSE UP ANTICAVITY TOOTHPASTE (ANTICAVITY TOOTHPASTE) GEL [KIK CUSTOM PRODUCTS]1Legacy NDC, 1 package rows20100327_9b17837b-85d2-49c7-8986-02bfb43ce739.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
Sodium FluorideACTIVE INGREDIENT8ZYQ1474W71
Fluoride IonACTIVE MOIETYQ80VPU408O1

Products#

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

DailyMed product names page 1 of 1 · 4 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
61047-77061047-770-10

Ingredients#

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

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

Name, UNII, Kind table
NameUNIIKind
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
ca1d569d-ac58-4351-a9ca-b3a86613abe19b17837b-85d2-49c7-8986-02bfb43ce7392010-03-25WarningsExact identifier
spl id: ca1d569d-ac58-4351-a9ca-b3a86613abe1
spl set id: 9b17837b-85d2-49c7-8986-02bfb43ce739

Reported adverse events (FAERS/openFDA)#

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