FDA.reportPublic FDA data

TopCare Sensitive

Manufacturer
TOPCO Assoc. LLC | Lornamead Products
Effective date
2026-01-08
Label type
HUMAN OTC DRUG LABEL
Version
14
Source
monthly-update
Hydrated at
2026-06-03 17:51:54

Label at a glance#

ProductTopCare Sensitive Extra Whitening
Active ingredientSODIUM FLUORIDE, POTASSIUM NITRATE
Label structure10 sections

Storage and handling

Other information Store in a cool dry place. Keep tube capped when not in use.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredients

Potassium nitrate 5%

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

OTC - PURPOSE SECTION

Purpose

Antihypersensitivity

Anticavity

INDICATIONS & USAGE SECTION

Uses

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

WARNINGS SECTION

Warnings

OTC - WHEN USING SECTION

​When using this product do not use longer than 4 weeks unless recommended by a dentist or physician.

OTC - STOP USE SECTION

See your dentist if the problem worsens. Sensitive teeth may indicate a serious problem that may need prompt care by a dentist.

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.

DOSAGE & ADMINISTRATION SECTION

Directions

Adults and children 12 years of age and older: Apply at least 1-inch strip of the product onto a soft bristle toothbrush.

  • Brush teeth thoroughly for at least one minute, preferably after each meal or at least twice a day (morning and evening) or as recommended by a dentist or physican. Make sure to brush all sensitive areas of the teeth.
  • Children under 12 years of age: Consult a dentist or physician.

STORAGE AND HANDLING SECTION

Other information

Store in a cool dry place. Keep tube capped when not in use.

INACTIVE INGREDIENT SECTION

Inactive ingredients cocamidopropyl betaine, flavor, glycerin, hydrated silica, PEG-8, sodium hydroxide, sodium methyl cocoyl taurate, sodium saccharin, sodium tripolyphosphate, sorbitol, titanium dioxide, water, xanthan gum

SPL UNCLASSIFIED SECTION

DISTRIBUTED BY TOPCO ASSOCIATES LLC

ELK GROVE VILLAGE, IL 60007

QUESTIONS? 1-888-423-0139 topcare@topco.com

www.topcarebrand.com

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Carton ArtworkCarton Artwork

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1038929potassium nitrate 5 % / sodium fluoride 0.24 % ToothpastePSN14
1038929potassium nitrate 0.05 MG/MG / sodium fluoride 0.0024 MG/MG ToothpasteSCD14
1038929K+ nitrate 0.05 MG/MG / Sodium Fluoride 0.0024 MG/MG ToothpasteSY14
1038929Pot nitrate 0.05 MG/MG / Sodium Fluoride 0.0024 MG/MG ToothpasteSY14
1038929potassium nitrate 5 % / sodium fluoride 0.24 % (fluoride ion 0.14 % ) ToothpasteSY14
1038929potassium nitrate 5 % / sodium fluoride 0.24 % (fluoride ion 0.15 % ) ToothpasteSY14
1038929potassium nitrate 5 % / sodium fluoride 0.24 % ToothpasteSY14

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
36800-451-59TopCare SensitiveExtra Whitening1 in 1 CARTONPASTE, DENTIFRICE114
36800-451-59TopCare SensitiveExtra Whitening113 g in 1 TUBEPASTE, DENTIFRICE11314

Products#

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

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
36800-45136800-451-59

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
WATER059QF0KO0RIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
SODIUM TRIPOLYPHOSPHATE5HK03SA80JIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
SORBITOL506T60A25RIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
SODIUM HYDROXIDE55X04QC32IIACT
GLYCERINPDC6A3C0OXIACT
XANTHAN GUMTTV12P4NEEIACT
HYDRATED SILICAY6O7T4G8P9IACT
COCAMIDOPROPYL BETAINE5OCF3O11KXIACT
SODIUM METHYL COCOYL TAURATEJVL98CG53GIACT
SODIUM FLUORIDE8ZYQ1474W7ACTIM
POTASSIUM NITRATERU45X2JN0ZACTIB

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
132025-08-08full-release2026-06-01 01:09:57

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
TopCare Sensitive Extra WhiteningPOTASSIUM NITRATE, SODIUM FLUORIDETOPCO Assoc. LLC835f41cf-e920-7df7-e053-2a91aa0a44792026-01-08WarningsExact identifier
ndc (package): 36800-451-59
ndc (product): 36800-451
ndc11 (package): 36800045159
spl id: 47e517a4-25d4-4a28-e063-6294a90a3453
spl set id: 835f41cf-e920-7df7-e053-2a91aa0a4479

Reported adverse events (FAERS/openFDA)#

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