FDA.reportPublic FDA data

Walgreens Sensitive Enamel Repair

Manufacturer
Walgreens | 1000120219
Effective date
2026-01-09
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
monthly-update
Hydrated at
2026-06-03 17:52:08

Label at a glance#

ProductWalgreens 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)

OTC - PURPOSE SECTION

Antihypersensitivity

Anticavity

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 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

Keap out of reach of children. If more than used for brushing is accidentally swallowed, get meedical help or contact a Poison Contrl Center right away.

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 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 sensistive 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

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

WLG_EnamelRepair_Intensive_CTN_2821095R1WLG_EnamelRepair_Intensive_CTN_2821095R1

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
0363-0593-10Walgreens Sensitive Enamel Repair96.4 g in 1 TUBEPASTE, DENTIFRICE96.42
0363-0593-10Walgreens 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
0363-05930363-0593-10

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
XANTHAN GUMTTV12P4NEEIACT
SODIUM SACCHARINSB8ZUX40TYIACT
GLYCERINPDC6A3C0OXIACT
WATER059QF0KO0RIACT
PEG-8B697894SGQIACT
SORBITOL506T60A25RIACT
SODIUM FLUORIDE8ZYQ1474W7ACTIM
POTASSIUM NITRATERU45X2JN0ZACTIB

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
Walgreens Sensitive Enamel RepairSODIUM FLUORIDEWalgreens41d6384d-695b-b60b-e063-6394a90aa0b92026-01-09WarningsExact identifier
ndc (package): 0363-0593-10
ndc (product): 0363-0593
ndc11 (package): 00363059310
spl id: 47f5bce2-57ad-de07-e063-6394a90a51d9
spl set id: 41d6384d-695b-b60b-e063-6394a90aa0b9

Reported adverse events (FAERS/openFDA)#

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