FDA.reportPublic FDA data

CVS Health Clinical White Stain Protector

Manufacturer
CVS Pharmacy | Lornamead Products
Effective date
2026-01-09
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
monthly-update
Hydrated at
2026-06-03 17:52:35

Label at a glance#

ProductCVS Health Clinical White Stain Protector
Active ingredientSODIUM FLUORIDE, POTASSIUM NITRATE
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Potassium nitrate 5%

Sodium fluoride 0.25% (0.15% w/v fluoride ion)

INDICATIONS & USAGE SECTION

Uses

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

WARNINGS SECTION

Stop use and ask a dentist if , the problem persists or worsen. 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.

DOSAGE & ADMINISTRATION SECTION

Directions

OTC - PURPOSE SECTION

Antihypersensitivity

Anticavity

INDICATIONS & USAGE SECTION

water, sorbitol, hydrated silica, glycerin, pentasodium triphosphate, peg-8, sodium lauryl sulfate, flavor, titanium dioxide, xanthan gum, cocamidorpopyl betaine, sodium hydroxide, carrageenan, sodium saccharin

INACTIVE INGREDIENT SECTION

water, sorbitol, hydrated silica, glycerin, pentasodium triphodphate, peg-8, sodium lauryl sulfate, flavor, titanium dioxide, xanthan gum, cocamidorpopyl betaine, sodium hydroxide, carrageenan, sodium saccharin

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CVS_ClinicalPlus_CTN_2821094R1CVS_ClinicalPlus_CTN_2821094R1

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1086243potassium nitrate 5 % / sodium fluoride 0.25 % ToothpastePSN2
1086243potassium nitrate 0.05 MG/MG / sodium fluoride 0.0025 MG/MG ToothpasteSCD2
1086243K+ nitrate 0.05 MG/MG / Sodium Fluoride 0.0025 MG/MG ToothpasteSY2
1086243Pot nitrate 0.05 MG/MG / Sodium Fluoride 0.0025 MG/MG ToothpasteSY2

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51316-205-10CVS Health Clinical White Stain Protector96.4 g in 1 TUBEPASTE, DENTIFRICE96.42
51316-205-10CVS Health Clinical White Stain Protector1 in 1 CARTONPASTE, DENTIFRICE12

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
51316-20551316-205-10

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
COCAMIDOPROPYL BETAINE5OCF3O11KXIACT
WATER059QF0KO0RIACT
SODIUM FLUORIDE8ZYQ1474W7ACTIM
SODIUM HYDROXIDE55X04QC32IIACT
SODIUM SACCHARINSB8ZUX40TYIACT
SORBITOL506T60A25RIACT
PEG-8B697894SGQIACT
POTASSIUM NITRATERU45X2JN0ZACTIB
HYDRATED SILICAY6O7T4G8P9IACT
XANTHAN GUMTTV12P4NEEIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
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
CVS Health Clinical White Stain ProtectorSODIUM FLUORIDECVS Pharmacy41d5c3a9-abe5-5528-e063-6294a90ada792026-01-09WarningsExact identifier
ndc (package): 51316-205-10
ndc (product): 51316-205
ndc11 (package): 51316020510
spl id: 47f94e5a-f2dd-5c9d-e063-6294a90a0a5f
spl set id: 41d5c3a9-abe5-5528-e063-6294a90ada79

Reported adverse events (FAERS/openFDA)#

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