FDA.reportPublic FDA data

Brushbuddies Shopkins Anticavity Tooth

Manufacturer
Ashtel Studio Inc | Foshan Nanhai JiaChun Biology Engineering Co., Ltd
Effective date
2016-11-29
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:48:05

Label at a glance#

ProductBrushbuddies Shopkins Anticavity Tooth
Active ingredientSODIUM MONOFLUOROPHOSPHATE
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient

Sodium Monofluorophosphate 0.5%

OTC - PURPOSE SECTION

Purpose:

Anticavity

INDICATIONS & USAGE SECTION

Uses:

Help protect teeth and roots against cavities

WARNINGS SECTION

Warnings:

If you accidentally swallow more than used for brushing, seek professional help or contact a Poison Control Center immediately

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 and older:
  • Brush teeth thoroughly after meals or at least twice a day or use as directed by a dentist.
  • Do not swallow
  • To minimize swallowing use a pea-sized amount in children under 6 years of age,
  • Supervise children's brushing untill good habits are established.

Children under 2 years of age:

  • Ask a dentist

INACTIVE INGREDIENT SECTION

Inactive Ingredients:

Sorbitor, Water, Silica, Sodium N-Lauroylsarcosinate, Xylitol, Flavor, Sodium Carboxymethylcellulose, Sodium Benzoate, Xanthan Gum, Sodium Pyrophosphate, Saccharin Sodium, Rose Red 1

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1094342sodium monofluorophosphate 0.66 % ToothpastePSN1
1094342sodium monofluorophosphate 0.0066 MG/MG ToothpasteSCD1
1094342sodium monofluorophosphate 0.66 % ToothpasteSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70108-501-012020-01-31C16284748780-19d75b9d0-9d24-f424-e053-dadaa90a57ce95bf8421-e166-42f7-8547-ba6358d44051

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70108-501-01Brushbuddies Shopkins Anticavity Tooth119 g in 1 TUBEPASTE, DENTIFRICE1191

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70108-501BRUSHBUDDIES SHOPKINS ANTICAVITY TOOTH (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [ASHTEL STUDIO INC]1Legacy NDC, 1 package rows20161205_95bf8421-e166-42f7-8547-ba6358d44051.zip

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70108-50170108-501-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
SODIUM MONOFLUOROPHOSPHATEC810JCZ56QACTIM
WATER059QF0KO0RIACT
SORBITOL506T60A25RIACT
XYLITOLVCQ006KQ1EIACT
CARBOXYMETHYLCELLULOSE SODIUMK679OBS311IACT
SODIUM BENZOATEOJ245FE5EUIACT
XANTHAN GUMTTV12P4NEEIACT
SODIUM PYROPHOSPHATEO352864B8ZIACT
SACCHARIN SODIUMSB8ZUX40TYIACT

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
a79b8c3d-2a7f-49d9-9a81-50ffc4e86c1595bf8421-e166-42f7-8547-ba6358d440512016-11-29WarningsExact identifier
spl id: a79b8c3d-2a7f-49d9-9a81-50ffc4e86c15
spl set id: 95bf8421-e166-42f7-8547-ba6358d44051

Reported adverse events (FAERS/openFDA)#

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