FDA.reportPublic FDA data

Brush Buddies 2 VALUE PACK CAVITY PROTECTION ANTI-CAVITY FLUORIDE

Manufacturer
Ashtel Studios, Inc.
Effective date
2025-08-13
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:11:11

Label at a glance#

ProductBrush Buddies 2 VALUE PACK CAVITY PROTECTION ANTI-CAVITY FLUORIDE
Active ingredientSODIUM MONOFLUOROPHOSPHATE
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 or physician • 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

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Sodium Monofluorophosphate 0.76% (0.15% w/v Fluoride ion)

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

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 or physician

• 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 ingredients

INACTIVE INGREDIENT SECTION

Calcium Carbonate, Aqua, Sorbitol, Silica, Sodium Lauryl Sulfate, Flavor, Benzyl Alcohol, PEG-8, Cellulose Gum, Trisodium Phosphate, Xanthan Gum, Sodium Saccharin, Sodium Benzoate, Titanium Dioxide, Sodium Silicate

Questions or comments?

OTC - QUESTIONS SECTION

Call toll free 1-877-274-8358

SPL UNCLASSIFIED SECTION

• HELPS FIGHT CAVITIES

• FRESHENS BREATH

• STRENGTHEN TEETH

• CLEANS TEETH THOROUGHLY

DESIGNED IN USA • MADE IN INDIA

WWW.BRUSHBUDDIES.COM

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

CAVITY PROTECTION ANTI-CAVITYCAVITY PROTECTION ANTI-CAVITY

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
545626sodium monofluorophosphate 0.76 % ToothpastePSN1
545626sodium monofluorophosphate 0.0076 MG/MG ToothpasteSCD1
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.12 % )ToothpasteSY1
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.13 % )ToothpasteSY1
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.14 % )ToothpasteSY1
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.15 % )ToothpasteSY1

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70108-185-01Brush Buddies 2 VALUE PACK CAVITY PROTECTION ANTI-CAVITY FLUORIDE2 in 1 BOXPASTE, DENTIFRICE21
70108-185-01Brush Buddies 2 VALUE PACK CAVITY PROTECTION ANTI-CAVITY FLUORIDE99 g in 1 TUBEPASTE, DENTIFRICE991

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70108-18570108-185-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Name, UNII, Kind table
NameUNIIKind
SODIUM MONOFLUOROPHOSPHATEC810JCZ56QACTIM
CALCIUM CARBONATEH0G9379FGKIACT
WATER059QF0KO0RIACT
SORBITOL506T60A25RIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
SODIUM LAURYL SULFATE368GB5141JIACT
BENZYL ALCOHOLLKG8494WBHIACT
POLYETHYLENE GLYCOL 400B697894SGQIACT
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIEDK679OBS311IACT
SODIUM PHOSPHATE, TRIBASIC, ANHYDROUSSX01TZO3QZIACT
XANTHAN GUMTTV12P4NEEIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
SODIUM BENZOATEOJ245FE5EUIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
SODIUM SILICATEIJF18F77L3IACT

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 2 VALUE PACK CAVITY PROTECTION ANTI-CAVITY FLUORIDESODIUM MONOFLUOROPHOSPHATEAshtel Studios, Inc.fc794fe5-7135-4b2b-b002-a75908223f202025-08-13WarningsExact identifier
ndc (package): 70108-185-01
ndc (product): 70108-185
ndc11 (package): 70108018501
spl id: bc846037-e4ff-4f64-b29b-67348a8b75bf
spl set id: fc794fe5-7135-4b2b-b002-a75908223f20

Reported adverse events (FAERS/openFDA)#

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