FDA.reportPublic FDA data

Farmasi Whitening

Manufacturer
Farmasi US LLC
Effective date
2023-11-05
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:58:54

Label at a glance#

ProductFarmasi Whitening
Active ingredientSODIUM FLUORIDE
Label structure8 sections

Indications and uses

Helps proctect teeth and prevents cavities. Whitens teeth by removing surface stains.

Dosage and administration

Adults and children 6 years of age and older: brush teeth thoroughly after meals of at least twice a day, or as directed by a dentist or physician.

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS

OTC - ACTIVE INGREDIENT SECTION

Sodium Fluoride 0.24 % (0.15% w/v fluoride ion)

PURPOSE

OTC - PURPOSE SECTION

Anticavity

USES

INDICATIONS & USAGE SECTION

Helps proctect teeth and prevents cavities. Whitens teeth by removing surface stains.

WARNINGS

WARNINGS SECTION

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

under 6 years of age. If more than used for brushing in accidentally swallowed, get medical help or contact a Poison Control Center right away.

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

Adults and children 6 years of age and older: brush teeth thoroughly after meals of at least twice a day, or as directed by a dentist or physician.

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

Calcium Carbonate, Sorbitol, Water/Aqua, Hydrated Silica, Lauryl Glucoside, Xanthan Gum, Flavour/Aroma, Titanium Dioxide, Sodium Benzoate, Sodium Saccharin, Tea Tree Oil/Melaleuca Alternifolia Leaf Oil, Panax Ginseng Root Extract, Aloe Juice/Aloe Barbadensis Leaf Juice, Salvadora Persica Bark/Root Extract.

Questions or Comments?

OTC - QUESTIONS SECTION

info@farmasius.com Monday - Friday (9 a.m - 6 p.m.EST) 1 786 238 7338

25g Package Labeling:

NONTERATOGENIC EFFECTS SECTION

25g Label25g Label25g Tube25g Tube25g Inner Label25g Inner Label

112g Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

tubetubeboxbox

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
416783sodium fluoride 0.24 % ToothpastePSN3
416783sodium fluoride 0.0024 MG/MG ToothpasteSCD3
416783sodium fluoride 0.24 % (fluoride ion 0.13 % ) ToothpasteSY3
416783sodium fluoride 0.24 % (fluoride ion 0.14 % ) ToothpasteSY3
416783sodium fluoride 0.24 % (fluoride ion 0.15 % ) ToothpasteSY3

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
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
74690-012-01Farmasi Whitening1 in 1 BOXPASTE, DENTIFRICE13
74690-012-01Farmasi Whitening112 g in 1 TUBEPASTE, DENTIFRICE1123
74690-012-02Farmasi Whitening25 g in 1 TUBEPASTE, DENTIFRICE253
74690-012-02Farmasi Whitening1 in 1 BOXPASTE, DENTIFRICE13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
74690-012FARMASI WHITENING (SODIUM FLUORIDE) PASTE, DENTIFRICE [FARMASI US LLC]3Current NDC, Legacy NDC, 4 package rows20231106_25b3608e-abed-41ca-9971-21981b8a4610.zip

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
74690-01274690-012-01, 74690-012-02

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
CALCIUM CARBONATEH0G9379FGKIACT
SORBITOL506T60A25RIACT
WATER059QF0KO0RIACT
HYDRATED SILICAY6O7T4G8P9IACT
LAURYL GLUCOSIDE76LN7P7UCUIACT
XANTHAN GUMTTV12P4NEEIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
SODIUM BENZOATEOJ245FE5EUIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
TEA TREE OILVIF565UC2GIACT
ASIAN GINSENGCUQ3A77YXIIACT
ALOE VERA LEAFZY81Z83H0XIACT
SALVADORA PERSICA ROOT526M7ZU616IACT
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
Farmasi WhiteningSODIUM FLUORIDEFarmasi US LLC25b3608e-abed-41ca-9971-21981b8a46102023-11-05WarningsExact identifier
ndc (package): 74690-012-02
ndc (package): 74690-012-01
ndc (product): 74690-012
ndc11 (package): 74690001202
ndc11 (package): 74690001201
spl id: 09734a55-efb4-3b22-e063-6394a90ad2d2
spl set id: 25b3608e-abed-41ca-9971-21981b8a4610

Reported adverse events (FAERS/openFDA)#

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