FDA.reportPublic FDA data

Sensitive Whitening Anticavity

Manufacturer
Topco | Lornamead Products
Effective date
2025-11-13
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 01:16:10

Label at a glance#

ProductSensitive Whitening Anticavity
Active ingredientSTANNOUS FLUORIDE
Label structure4 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient Purpose

Stannous fluoride 0.454% (0.15% w/v fluoride ion) .......................... Anticavity/Antihypersensitivity

INDICATIONS & USAGE SECTION

Uses

OTC - PURPOSE SECTION

  • aids in the prevention of dental cavities
  • builds increasing protection against painful sensitivity of the teeth to cold, heat, acids, sweets or contact

WARNINGS SECTION

When using this product, if irritation occurs discontinue use

Stop use and ask a dentist if

  • the problem persists or worsens. Sensitive teeth may indicate a serious problem that may need prompt care by a dentist
  • pain/sensitivity still persists after 4 weeks of use
OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. 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 12 years of age and older: apply at least a 1-inch strip of the product onto a soft bristle toothbrush

  • brush teeth thoroughly for at least one minute twise a day (morning and evening), and not more than 3 times a day, or as recommended by a dentist or doctor. Make sure to brush all sensitive areas of the teeth. Minimize swallowing. Spit out after brushing.
  • children under 12 years of age: Consult a dentist or doctor.

Other information

OTHER SAFETY INFORMATION

products containing stannous fluoride may produce surface staining of the teeth. Adequate toothbrushing may prevent these stains which are not harmful or permanent and may be removed by your dentist

this product is specifically formulated to prevent staining

store below 30°C (86°F)

INACTIVE INGREDIENT SECTION

glycerin, water, hydrated silica, pentasodium triphosphate, flavor, cocamidopropyl betaine, sodium lauryl sulfate, titanium dioxide, cellulose gum, sodium saccharin

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Carton ArtworkCarton ArtworkWhitening

Sensitive

Anticavity Toothpaste for Sensitive Teeth

Net Wt 3.4 oz (96.3g)

Compare to Sensodyne

Repair & Protect Active Ingredient*

Restore

& Defend

Builds protective coating on

sensitive areas of teeth

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
416784stannous fluoride 0.454 % (fluoride ion 0.16 % ) ToothpastePSN6
416784stannous fluoride 0.00454 MG/MG ToothpasteSCD6
416784stannous fluoride 0.454 % (fluoride ion 0.14 % ) ToothpasteSY6
416784stannous fluoride 0.454 % (fluoride ion 0.15 % ) ToothpasteSY6
416784stannous fluoride 0.454 % (fluoride ion 0.16 % ) ToothpasteSY6

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
36800-201-19Sensitive Whitening Anticavity1 in 1 CARTONPASTE, DENTIFRICE16
36800-201-19Sensitive Whitening Anticavity113 g in 1 TUBEPASTE, DENTIFRICE1136

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
36800-20136800-201-19

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
STANNOUS FLUORIDE3FTR44B32QACTIM
SACCHARIN SODIUMSB8ZUX40TYIACT
WATER059QF0KO0RIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORMK679OBS311IACT
COCAMIDOPROPYL BETAINE5OCF3O11KXIACT
SODIUM LAURYL SULFATE368GB5141JIACT
HYDRATED SILICAY6O7T4G8P9IACT
SODIUM TRIPOLYPHOSPHATE ANHYDROUS9SW4PFD2FZIACT
GLYCERINPDC6A3C0OXIACT

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
Sensitive Whitening AnticavitySTANNOUS FLOURIDETopco96384c9d-cb42-7654-e053-2995a90aac082025-11-13WarningsExact identifier
ndc (package): 36800-201-19
ndc (product): 36800-201
ndc11 (package): 36800020119
spl id: 437fb9ec-4972-a4cb-e063-6394a90a1434
spl set id: 96384c9d-cb42-7654-e053-2995a90aac08

Reported adverse events (FAERS/openFDA)#

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