FDA.reportPublic FDA data

dentalux ANTI-CAVITY FLUORIDE

Manufacturer
Lidl US, LLC
Effective date
2024-07-02
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:38:08

Label at a glance#

Productdentalux ANTI-CAVITY FLUORIDE
Active ingredientSODIUM MONOFLUOROPHOSPHATE
Label structure9 sections

Indications and uses

helps protect against cavities.

Dosage and administration

• adults and children 2 years and older: brush teeth thoroughly after meals or at least twice a day or use as directed by a dentist. • do not swallow . •  children 2 to 6 years: to minimize swallowing use a pea-sized amount and supervise children's brushing and rinsing until good habits are established. • children under 2 years of age: Consult a dentist or doctor.

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Sodium Monofluorophosphate 0.76%
(0.13% w/v Fluoride ion)

Purpose

OTC - PURPOSE SECTION

Anticavity

Uses

INDICATIONS & USAGE SECTION

helps protect against cavities.

Warnings

WARNINGS SECTION

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children under 6 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 2 years and older: brush teeth thoroughly after meals or at least twice a day or use as directed by a dentist.
• do not swallow.
• children 2 to 6 years: to minimize swallowing use a pea-sized amount and supervise children's brushing and rinsing until good habits are established.
• children under 2 years of age: Consult a dentist or doctor.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Sorbitol, Hydrated Silica, Treated Water (Aqua), Poly Ethylene Glycol 1500 (PEG 32), Sodium Lauryl Sulphate, Glycerin, Flavor, Cellulose Gum, Titanium Dioxide (CI 77891), Tetra Sodium Pyrophosphate, Sodium Benzoate, Benzyl Alcohol, Sodium Saccharin, Trisodium Phosphate

Questions or comments?

OTC - QUESTIONS SECTION

Call toll free 1-877-274-8358

SPL UNCLASSIFIED SECTION

COMPARE TO Colgate Cavity Protection*

• HELPS PREVENT CAVITIES
• GREAT MINT TASTE

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 COLGATE-PALMOLIVE COMPANY, OWNER OF THE REGISTERED TRADEMARK COLGATE®.

Lidl Love It!
GUARANTEE
√money refunded
√item replaced

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

dentalux ANTI-CAVITYdentalux ANTI-CAVITY

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
545626sodium monofluorophosphate 0.76 % ToothpastePSN1
545626sodium monofluorophosphate 0.0076 MG/MG ToothpasteSCD1
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.12 % )ToothpasteSY1
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.13 % )ToothpasteSY1
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.14 % )ToothpasteSY1
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.15 % )ToothpasteSY1

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71141-186-10dentalux ANTI-CAVITY FLUORIDE1 in 1 BOXPASTE, DENTIFRICE11
71141-186-10dentalux ANTI-CAVITY FLUORIDE113 g in 1 TUBEPASTE, DENTIFRICE1131

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71141-186DENTALUX ANTI-CAVITY FLUORIDE (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [LIDL US, LLC]1Current NDC, 2 package rows20241121_ccf54743-81c2-43f8-9c5c-d4baa85fc18d.zip

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71141-18671141-186-10

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
SODIUM MONOFLUOROPHOSPHATEC810JCZ56QACTIM
SORBITOL506T60A25RIACT
HYDRATED SILICAY6O7T4G8P9IACT
WATER059QF0KO0RIACT
POLYETHYLENE GLYCOL 16001212Z7S33AIACT
SODIUM LAURYL SULFATE368GB5141JIACT
GLYCERINPDC6A3C0OXIACT
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIEDK679OBS311IACT
TITANIUM DIOXIDE15FIX9V2JPIACT
SODIUM PYROPHOSPHATEO352864B8ZIACT
SODIUM BENZOATEOJ245FE5EUIACT
BENZYL ALCOHOLLKG8494WBHIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
SODIUM PHOSPHATE, TRIBASIC, ANHYDROUSSX01TZO3QZIACT

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 ANTI-CAVITY FLUORIDESODIUM MONOFLUOROPHOSPHATELidl US, LLCccf54743-81c2-43f8-9c5c-d4baa85fc18d2024-07-02WarningsExact identifier
ndc (package): 71141-186-10
ndc (product): 71141-186
ndc11 (package): 71141018610
spl id: 77de6540-40df-4421-9242-a418ba5c2074
spl set id: ccf54743-81c2-43f8-9c5c-d4baa85fc18d

Reported adverse events (FAERS/openFDA)#

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