FDA.reportPublic FDA data

Supersmile

Manufacturer
Robell Research, Inc | Lornamead Products
Effective date
2026-01-08
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
monthly-update
Hydrated at
2026-06-03 17:52:12

Label at a glance#

ProductSupersmile Professional Whitening TP Citrus Blast
Active ingredientSODIUM MONOFLUOROPHOSPHATE
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Sodium Monoflurophosphate (0.14% w/v Fluoride Ion) .................... Anticavity

INACTIVE INGREDIENT SECTION

Water, Sorbitol, Dicalcium Phosphate, Calcium Carbonate, Sodium Bicarbonate, Titanium Dioxide, Cellulose Gum, Calprox®, Sodium Perborate, Corn Starch, Flavor, Magnesium Carbonate, Sodium Lauryl Sulfoacetate, Sodium Saccharin

OTC - PURPOSE SECTION

Aids in the prevention of dental cavities

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children under 6 years old. If you accidentally swallow more than used for brushing, get medical help or call a Posion control center rigth away.

INDICATIONS & USAGE SECTION

Place a pearl-sized drop of Whitening toothpaste on a dry toothbrush and brush in a circular motion for 2 minutes, 2x a day.

DOSAGE & ADMINISTRATION SECTION

Adults and children 2 years of age and older: Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or doctor. Instruc children under 6 years of age in good brushing and rinsing habits (to minimize swallowing). Supervise children as necessary until capable of using wihtout supervision. Children under 2 years of age: Consult a dentist or doctor.

WARNINGS SECTION

Keep out of reach of children under 6 years old. If you accedentally swallow more than used for brushing, get medical help or call a Posion control center rigth away.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Supersmile Professional Whitening Toothpaste Citrus BlastSupersmile Professional Whitening Toothpaste Citrus Blast

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2695772sodium monofluorophosphate 0.79 % ToothpastePSN3
2695772sodium monofluorophosphate 0.0079 MG/MG ToothpasteSCD3
2695772sodium monofluorophosphate 0.79 % (fluoride ion 0.14 % )ToothpasteSY3

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
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
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53567-0036-1SupersmileProfessional Whitening TP Citrus Blast227 g in 1 TUBEPASTE, DENTIFRICE2273

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
53567-003653567-0036-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
NameUNIIKind
SORBITOL506T60A25RIACT
DIBASIC CALCIUM PHOSPHATE DIHYDRATEO7TSZ97GEPIACT
SODIUM MONOFLUOROPHOSPHATEC810JCZ56QACTIM
STARCH, CORNO8232NY3SJIACT
SODIUM LAURYL SULFOACETATED0Y70F2B9JIACT
CALCIUM CARBONATEH0G9379FGKIACT
CARBOXYMETHYLCELLULOSE SODIUMK679OBS311IACT
WATER059QF0KO0RIACT
MAGNESIUM CARBONATE0E53J927NAIACT
CALCIUM PEROXIDE7FRO2ENO91IACT
SODIUM BICARBONATE8MDF5V39QOIACT
SODIUM PERBORATE TETRAHYDRATE822HSQ655RIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
TITANIUM DIOXIDE15FIX9V2JPIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
22025-01-17full-release2026-06-01 00:52:59

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
Supersmile Professional Whitening TP Citrus BlastSODIUM MONOFLUOROPHOSPHATERobell Research, Inc25039552-c35d-a69d-e063-6394a90ab1032026-01-08WarningsExact identifier
ndc (package): 53567-0036-1
ndc (product): 53567-0036
ndc11 (package): 53567003601
spl id: 47e57b98-fb54-24a5-e063-6294a90a785b
spl set id: 25039552-c35d-a69d-e063-6394a90ab103

Reported adverse events (FAERS/openFDA)#

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