FDA.reportPublic FDA data

CVS Health Sensitive Enamel Repair

Manufacturer
CVS | 1000120219
Effective date
2026-01-09
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
monthly-update
Hydrated at
2026-06-03 17:52:07

Label at a glance#

ProductCVS Health Sensitive Enamel Repair
Active ingredientSODIUM FLUORIDE, POTASSIUM NITRATE
Label structure7 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 increasing protection against painful sensitivity of the teeth to cold, heat, acids, sweets or contact
  • aids in the prevention of dental cavities

WARNINGS SECTION

When using this product, if irritation occurs discontinue use.

OTC - STOP USE SECTION

Stop use and ask a dentist if

  • the problem persists or worsens. Sensitive teeth may indicare a seriuous 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

Adults and children 12 years older : apply at least a 1-inch strip of the product into a soft bristle toothbrush

  • brus teeth thoroughly for at least one minute twice 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 snesitive areas of the teeth. Minimize swallowing. Spit out after brushing.
  • Children under 12 years of age: Consult a dentist or doctor.

INACTIVE INGREDIENT SECTION

water, hydrated silica, sorbitol, glycerin, PEG-8, flavor, cocamidopropyl betaine, titanium dioxide, xanthan gum, sodium saccharin, sodium hydroxide

OTC - PURPOSE SECTION

Antihypersensitivity

Anticavity

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CVS_EnamelREpair_Intensive_2821093R1CVS_EnamelREpair_Intensive_2821093R1

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
51316-169-10CVS Health Sensitive Enamel Repair96.4 g in 1 TUBEPASTE, DENTIFRICE96.42
51316-169-10CVS Health Sensitive Enamel Repair1 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
51316-16951316-169-10

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
HYDRATED SILICAY6O7T4G8P9IACT
COCAMIDOPROPYL BETAINE5OCF3O11KXIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
SODIUM HYDROXIDE55X04QC32IIACT
SODIUM FLUORIDE8ZYQ1474W7ACTIM
XANTHAN GUMTTV12P4NEEIACT
POTASSIUM NITRATERU45X2JN0ZACTIB
SODIUM SACCHARINSB8ZUX40TYIACT
GLYCERINPDC6A3C0OXIACT
WATER059QF0KO0RIACT
PEG-8B697894SGQIACT
SORBITOL506T60A25RIACT

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 Sensitive Enamel RepairSODIUM FLUORIDECVS41d547b3-2feb-8e83-e063-6294a90ae3cd2026-01-09WarningsExact identifier
ndc (package): 51316-169-10
ndc (product): 51316-169
ndc11 (package): 51316016910
spl id: 47f95dac-296a-3639-e063-6394a90abc25
spl set id: 41d547b3-2feb-8e83-e063-6294a90ae3cd

Reported adverse events (FAERS/openFDA)#

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