FDA.reportPublic FDA data

dentalux SENSITIVE ANTI-CAVITY FLUORIDE

Manufacturer
Lidl US, LLC
Effective date
2024-07-03
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:38:07

Label at a glance#

Productdentalux SENSITIVE ANTI-CAVITY FLUORIDE
Active ingredientPOTASSIUM NITRATE, SODIUM FLUORIDE
Label structure9 sections

Indications and uses

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

Dosage and administration

• adults and children 12 years & older: • apply at least a 1-inch strip of the product onto a soft bristle toothbrush • brush teeth thoroughly after meals or at least twice a day or use as directed by a dentist. 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.

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Potassium Nitrate 5%
Sodium Fluoride 0.24% (0.15% w/v Fluoride ion)

Purpose

OTC - PURPOSE SECTION

Antihypersensitivity
Anticavity

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS 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

Keep out of reach of children under 12 years of age. 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 & older: • apply at least a 1-inch strip of the product onto a soft bristle toothbrush
• brush teeth thoroughly after meals or at least twice a day or use as directed by a dentist. 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.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Sorbitol, Hydrated Silica, Treated Water, PEG-1500, Sodium Lauryl Sulphate, Flavor, Glycerin, Cellulose Gum, Tetrasodium Pyrophosphate, Titanium Dioxide, Sodium Benzoate, Trisodium Phosphate, Sodium Saccharin, Sodium Hydroxide, Methylparaben, Propylparaben

Questions or comments?

OTC - QUESTIONS SECTION

Call toll free 1-877-274-8358

SPL UNCLASSIFIED SECTION

*COMPARE TO Sensodyne® Extra Whitening

• HELPS PREVENT CAVITIES

• HELPS RELIEVE SENSITIVITY

• EXTRA WHITENING

HELPS REMOVE STAINS
FOR A WHITER SMILE

DISTRIBUTED BY LIDL US, LLC
3500 S. CLARK STREET,
ARLINGTON, VA 22202
PRODUCT OF INDIA
1-844-344-5071
WWW.LIDL.COM

*THIS PRODUCT IS NOT MANUFACTURED OR DISTRIBUTED BY THE GLAXOSMITHKLINE CONSUMER HEALTHCARE HOLDINGS LLC, OWNER OF THE REGISTERED TRADEMARK SENSODYNE®.

Lidl Love It!
GUARANTEE
✔money refunded
✓item replaced

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SENSITIVESENSITIVE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1038929potassium nitrate 5 % / sodium fluoride 0.24 % ToothpastePSN1
1038929potassium nitrate 0.05 MG/MG / sodium fluoride 0.0024 MG/MG ToothpasteSCD1
1038929K+ nitrate 0.05 MG/MG / Sodium Fluoride 0.0024 MG/MG ToothpasteSY1
1038929Pot nitrate 0.05 MG/MG / Sodium Fluoride 0.0024 MG/MG ToothpasteSY1
1038929potassium nitrate 5 % / sodium fluoride 0.24 % (fluoride ion 0.14 % ) ToothpasteSY1
1038929potassium nitrate 5 % / sodium fluoride 0.24 % (fluoride ion 0.15 % ) ToothpasteSY1
1038929potassium nitrate 5 % / sodium fluoride 0.24 % ToothpasteSY1

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71141-187-10dentalux SENSITIVE ANTI-CAVITY FLUORIDE1 in 1 BOXPASTE, DENTIFRICE11
71141-187-10dentalux SENSITIVE ANTI-CAVITY FLUORIDE113 g in 1 TUBEPASTE, DENTIFRICE1131

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71141-187DENTALUX SENSITIVE ANTI-CAVITY FLUORIDE (POTASSIUM NITRATE, SODIUM FLUORIDE) PASTE, DENTIFRICE [LIDL US, LLC]1Current NDC, 2 package rows20241121_baef7f15-8082-4e61-8c08-8beda8ad40c0.zip

Products#

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

DailyMed product names page 1 of 1 · 21 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71141-18771141-187-10

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 17 matching rows.

Name, UNII, Kind table
NameUNIIKind
POTASSIUM NITRATERU45X2JN0ZACTIB
SODIUM FLUORIDE8ZYQ1474W7ACTIB
SORBITOL506T60A25RIACT
HYDRATED SILICAY6O7T4G8P9IACT
WATER059QF0KO0RIACT
POLYETHYLENE GLYCOL 16001212Z7S33AIACT
SODIUM LAURYL SULFATE368GB5141JIACT
GLYCERINPDC6A3C0OXIACT
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIEDK679OBS311IACT
SODIUM PYROPHOSPHATEO352864B8ZIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
SODIUM BENZOATEOJ245FE5EUIACT
SODIUM PHOSPHATE, TRIBASIC, ANHYDROUSSX01TZO3QZIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
SODIUM HYDROXIDE55X04QC32IIACT
METHYLPARABENA2I8C7HI9TIACT
PROPYLPARABENZ8IX2SC1OHIACT

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
dentalux SENSITIVE ANTI-CAVITY FLUORIDEPOTASSIUM NITRATE, SODIUM FLUORIDELidl US, LLCbaef7f15-8082-4e61-8c08-8beda8ad40c02024-07-03WarningsExact identifier
ndc (package): 71141-187-10
ndc (product): 71141-187
ndc11 (package): 71141018710
spl id: fc734f34-1c0f-4211-b5aa-bbd0ba55d821
spl set id: baef7f15-8082-4e61-8c08-8beda8ad40c0

Reported adverse events (FAERS/openFDA)#

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