FDA.reportPublic FDA data

Brush Buddies MY LITTLE PONY ANTICAVITY FLUORIDE

Manufacturer
Ashtel Studios, Inc.
Effective date
2025-01-29
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:54:19

Label at a glance#

ProductBrush Buddies MY LITTLE PONY ANTICAVITY FLUORIDE
Active ingredientSODIUM FLUORIDE
Label structure9 sections

Indications and uses

helps protect against cavities.

Dosage and administration

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. Children 2 to 6 years: to minimize swallowing use a pea-sized amount and supervise children's brushing and rinsing until good habits are established. Children under 2 years of age: Consult a dentist or doctor.

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Sodium Fluoride 0.243% 
(Fluoride ion content 1100 ppm)

Purpose

OTC - PURPOSE SECTION

Anticavity

Uses

INDICATIONS & USAGE SECTION

helps protect against cavities.

Warnings

WARNINGS SECTION

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children under 6 years of age. If you accidently swallow more than used for brushing, seek professional help or contact a Poison Control Center immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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.
  • Children 2 to 6 years: to minimize swallowing use a pea-sized amount and supervise children's brushing and rinsing until good habits are established.
  • Children under 2 years of age: Consult a dentist or doctor.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Sorbitol, Silica, Water, PEG-32, Xylitol, Sodium Lauryl Sulfate, Flavor, Cellulose Gum, Benzyl Alcohol, Sodium Benzoate, Sodium Saccharin, Trisodium Phosphate, FD&C Red 40

Questions or comments?

OTC - QUESTIONS SECTION

Call toll free 1-877-274-8358

SPL UNCLASSIFIED SECTION

BrushBuddies®

BUBBLe GUM FLAVOR

HeLPS PReVeNT CAViTieS

make brushing fun!®

CAUTION:
AVOID EXCESSIVE INGESTION.
NOT FOR PETS.
NOT TESTED ON ANIMALS.

MY LITTLE PONY and all related characters are trademarks of Hasbro and are used with permission.
©2025 Hasbro. All Rights Reserved. Licensed by Hasbro

DESIGNED IN U.S.A. • MADE IN INDIA

WWW.BRUSHBUDDIES.COM
QUESTIONS OR COMMENTS?
1-909-434-0911 INTERNATIONAL

PATENTS, COPYRIGHTS & TRADEMARKS GRANTED OR PENDING WORLDWIDE

DISTRIBUTED BY ASHTEL STUDIOS INC.
ONTARIO, CALIFORNIA 91761

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Fl toothpasteFl toothpaste

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
891775sodium fluoride 0.243 % ToothpastePSN1
891775sodium fluoride 0.00243 MG/MG ToothpasteSCD1
891775sodium fluoride 0.243 % (fluoride ion 0.13 % ) ToothpasteSY1
891775sodium fluoride 0.243 % (fluoride ion 0.14 % ) ToothpasteSY1
891775sodium fluoride 0.243 % (fluoride ion 0.15 % ) ToothpasteSY1
891775sodium fluoride 0.243 % (fluoride ion 0.16 % ) ToothpasteSY1

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70108-112-01Brush Buddies MY LITTLE PONY ANTICAVITY FLUORIDE1 in 1 BOXPASTE, DENTIFRICE11
70108-112-01Brush Buddies MY LITTLE PONY ANTICAVITY FLUORIDE113 g in 1 TUBEPASTE, DENTIFRICE1131

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70108-112BRUSH BUDDIES MY LITTLE PONY ANTICAVITY FLUORIDE (SODIUM FLUORIDE) PASTE, DENTIFRICE [ASHTEL STUDIOS, INC.]1Current NDC, 2 package rows20250205_7e8944d3-b8d6-44e6-b38b-f80e4cd28ee4.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
70108-11270108-112-01

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
SODIUM FLUORIDE8ZYQ1474W7ACTIB
SORBITOL506T60A25RIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
WATER059QF0KO0RIACT
POLYETHYLENE GLYCOL 16001212Z7S33AIACT
XYLITOLVCQ006KQ1EIACT
SODIUM LAURYL SULFATE368GB5141JIACT
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIEDK679OBS311IACT
BENZYL ALCOHOLLKG8494WBHIACT
SODIUM BENZOATEOJ245FE5EUIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
SODIUM PHOSPHATE, TRIBASIC, ANHYDROUSSX01TZO3QZIACT
FD&C RED NO. 40WZB9127XOAIACT

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
Brush Buddies MY LITTLE PONY ANTICAVITY FLUORIDESODIUM FLUORIDEAshtel Studios, Inc.7e8944d3-b8d6-44e6-b38b-f80e4cd28ee42025-01-29WarningsExact identifier
ndc (package): 70108-112-01
ndc (product): 70108-112
ndc11 (package): 70108011201
spl id: 0ec76812-99d7-4486-8779-f310796dc4b7
spl set id: 7e8944d3-b8d6-44e6-b38b-f80e4cd28ee4

Reported adverse events (FAERS/openFDA)#

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