FDA.reportPublic FDA data

Jason Powersmile Anticavity Whitening Peppermint

Manufacturer
The Hain Celestial Group, Inc.
Effective date
2021-04-12
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-05-31 23:39:37

Label at a glance#

ProductJason Powersmile Anticavity Whitening Peppermint
Active ingredientSODIUM MONOFLUOROPHOSPHATE
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION



Sodium Monofluorophosphate 0.76%

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 drushing. 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 physician). Children under 6: Should use only a pea sized amount of paste and be supervised as necessary. Children under 2, check with a dentist or physician before using.

INACTIVE INGREDIENT SECTION

Glycerin, Aqua (Water), Silica, Sodium Cocoyl Glutamate, Xylitol, Mentha Piperita (Peppermint) Oil, Aloe Barbadensis Leaf Juice (1), Bambusa Arundinacea Stem Powder, Citrus Grandis (Grapefruit) Seed Extract, Perilla Ocymoides Seed Extract, Stevia Rebaudiana Leaf/Steam Extract, Calcium Carbonate, Cellulose Gum, Dimethyl Sulfone, Sea Salt, Tocopheryl Acetate, Sodium Bicarbonate, Sodium Magnesium Silicate, Sodium Sulfatre, Ubiquinone (2).

(1) Certified Organic Ingredients

(2) Coenzyme Q10

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

tube labeltube labelcarton labelcarton label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
545626sodium monofluorophosphate 0.76 % ToothpastePSN4
545626sodium monofluorophosphate 0.0076 MG/MG ToothpasteSCD4
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.12 % )ToothpasteSY4
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.13 % )ToothpasteSY4
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.14 % )ToothpasteSY4
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.15 % )ToothpasteSY4

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61995-0540-62023-01-30C16284748780-1ba0f9c33-46c8-a910-e053-dadaa90a0b85Jason Powersmile Anticavity Whitening Peppermint
61995-0540-62021-02-05C16284748780-1ba0f9c33-46c8-a910-e053-dadaa90a0b85Jason Powersmile Anticavity Whitening Peppermint
61995-0540-62021-01-29C16284748780-1ba0f9c33-46c8-a910-e053-dadaa90a0b85Jason Powersmile Anticavity Whitening Peppermint

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61995-0540-6Jason Powersmile Anticavity Whitening Peppermint1 in 1 CARTONGEL14
61995-0540-6Jason Powersmile Anticavity Whitening Peppermint170 g in 1 TUBEGEL1704

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61995-0540JASON POWERSMILE ANTICAVITY WHITENING PEPPERMINT (SODIUM MONOFLUOROPHOSPHATE) GEL [THE HAIN CELESTIAL GROUP, INC.]4Legacy NDC, 2 package rows20210413_663b00d2-2a68-02a8-e053-2a91aa0a2c73.zip

Products#

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

DailyMed product names page 1 of 1 · 24 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
61995-054061995-0540-6

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 21 matching rows.

Name, UNII, Kind table
NameUNIIKind
SODIUM SULFATE0YPR65R21JIACT
SODIUM COCOYL GLUTAMATEBMT4RCZ3HGIACT
GLYCERINPDC6A3C0OXIACT
WATER059QF0KO0RIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
XYLITOLVCQ006KQ1EIACT
ALOE VERA LEAFZY81Z83H0XIACT
BAMBUSA ARUNDINACEA STEMNRA4497HC5IACT
CITRUS MAXIMA SEED083X55C543IACT
PERILLA FRUTESCENS SEED8M62PUD356IACT
STEVIA REBAUDIUNA LEAF6TC6NN0876IACT
UBIDECARENONEEJ27X76M46IACT
MAGNESIUM SILICATE9B9691B2N9IACT
SEA SALT87GE52P74GIACT
CALCIUM CARBONATEH0G9379FGKIACT
CARBOXYMETHYLCELLULOSE SODIUMK679OBS311IACT
DIMETHYL SULFONE9H4PO4Z4FTIACT
SODIUM BICARBONATE8MDF5V39QOIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
SODIUM MONOFLUOROPHOSPHATEC810JCZ56QACTIM
PEPPERMINT OILAV092KU4JHIACT

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
bfc8ea6a-7662-31cc-e053-2a95a90a97a9663b00d2-2a68-02a8-e053-2a91aa0a2c732021-04-12WarningsExact identifier
spl id: bfc8ea6a-7662-31cc-e053-2a95a90a97a9
spl set id: 663b00d2-2a68-02a8-e053-2a91aa0a2c73

Reported adverse events (FAERS/openFDA)#

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