FDA.reportPublic FDA data

Jason Powersmile Fluoride Peppermint Anticavity

Manufacturer
The Hain Celestial Group, Inc.
Effective date
2024-11-28
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:39:48

Label at a glance#

ProductJason Powersmile Fluoride Peppermint Anticavity
Active ingredientSODIUM FLUORIDE
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION



Sodium Fluoride 0.24%

OTC - PURPOSE SECTION

Anticavity

INDICATIONS & USAGE SECTION



use: Prevention of cavities

WARNINGS SECTION

Avoid storing at high temperatures (greater than 100°F). Protect from freezing. If you accidentally swalow more than used for brushing, seek professional assistance or contact Poison Control immediately.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children under 6 years of age.If you accidentally swallow more than used for brushing, get medical help or contact Poison Control Center immediately.

DOSAGE & ADMINISTRATION SECTION

Prevent plaque and tartar buildup with regular brushing. Adults and children 2 years of age or older should brush teeth after each meal (or at least twice a day, or as directed by a dentist or doctor). Children under 6: To minimize swallowing, use a pea sized amount of paste and supervise rushing until good habits are established. Children under 2, check with a dentist or physician before using.

INACTIVE INGREDIENT SECTION

Glycerin, Water (Aqua), Hydrated Silica, Sodium Laurylglucosides Hydroxypropylsulfonate, Titanium Dioxide, Mentha Piperita (Peppermint) Oil, Chondrus Crispus (Carrageenan), Stevia Rebaudiana Leaf/Stem Extract, Citric Acid, Menthol, Sodium Bicarbonate, Sodium Chloride, Xanthan Gum, Sodium Benzoate

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Peppermint CartonPeppermint Carton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
416783sodium fluoride 0.24 % ToothpastePSN2
416783sodium fluoride 0.0024 MG/MG ToothpasteSCD2
416783sodium fluoride 0.24 % (fluoride ion 0.13 % ) ToothpasteSY2
416783sodium fluoride 0.24 % (fluoride ion 0.14 % ) ToothpasteSY2
416783sodium fluoride 0.24 % (fluoride ion 0.15 % ) ToothpasteSY2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61995-0600-12025-07-29C16284748780-13b156c62-2730-fb37-e063-e6dba90a4e07Jason Powersmile Anticavity Whitening Peppermint

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61995-0600-1Jason Powersmile Fluoride Peppermint Anticavity119 g in 1 TUBEGEL1192
61995-0600-1Jason Powersmile Fluoride Peppermint Anticavity1 in 1 CARTONGEL12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61995-0600JASON POWERSMILE FLUORIDE PEPPERMINT ANTICAVITY (SODIUM FLUORIDE) GEL [THE HAIN CELESTIAL GROUP, INC.]22 package rows20241130_fd27af7b-6f61-aa84-e053-6294a90aae0a.zip

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
61995-060061995-0600-1

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
GLYCERINPDC6A3C0OXIACT
WATER059QF0KO0RIACT
HYDRATED SILICAY6O7T4G8P9IACT
SODIUM LAURYLGLUCOSIDES HYDROXYPROPYLSULFONATEZ6GFR7R72YIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
PEPPERMINT OILAV092KU4JHIACT
CARRAGEENAN5C69YCD2YJIACT
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
STEVIA REBAUDIUNA LEAF6TC6NN0876IACT
MENTHOL, (+)-C6B1OE8P3WIACT
SODIUM CHLORIDE451W47IQ8XIACT
XANTHAN GUMTTV12P4NEEIACT
SODIUM BENZOATEOJ245FE5EUIACT
SODIUM BICARBONATE8MDF5V39QOIACT
SODIUM FLUORIDE8ZYQ1474W7ACTIM

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
27ffbde9-e92c-79ce-e063-6394a90a3aa7fd27af7b-6f61-aa84-e053-6294a90aae0a2024-11-28WarningsExact identifier
spl id: 27ffbde9-e92c-79ce-e063-6394a90a3aa7
spl set id: fd27af7b-6f61-aa84-e053-6294a90aae0a

Reported adverse events (FAERS/openFDA)#

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