FDA.reportPublic FDA data

dentalux Kids ANTI-CAVITY FLUORIDE Bubble Gum

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 00:37:54

Label at a glance#

Productdentalux Kids ANTI-CAVITY FLUORIDE Bubble Gum
Active ingredientSODIUM FLUORIDE
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 Fluoride
0.243 % (0.15 % 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, Treated Water (Aqua), Hydrated Silica, PEG-1500, Sodium Lauryl Sulphate, Flavor, Cellulose Gum, Benzyl Alcohol, Sodium Benzoate, Sodium Saccharin, Trisodium phosphate, Carbomer, Tetrasodium Pyrophosphate, Mica, Titanium Dioxide, FD&C Blue 1

Questions or comments?

OTC - QUESTIONS SECTION

Call toll free 1-877-274-8358

SPL UNCLASSIFIED SECTION

*COMPARE TO Kid's Crest® Cavity Protection

Bubble Gum Fun

HELPS PROTECT AGAINST CAVITIES

DISTRIBUTED BY LIDL US, LLC
ARLINGTON, VA 22202
PRODUCT OF INDIA
1-844-344-5071

*THIS PRODUCT IS NOT MANUFACTURED OR DISTRIBUTED BY THE PROCTER & GAMBLE COMPANY, OWNER OF THE REGISTERED TRADEMARK KID'S CREST®.

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

dentalux Kidsdentalux Kids

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
891775sodium fluoride 0.243 % ToothpastePSN1
891775sodium fluoride 0.00243 MG/MG ToothpasteSCD1
891775sodium fluoride 0.243 % (fluoride ion 0.13 % ) ToothpasteSY1
891775sodium fluoride 0.243 % (fluoride ion 0.14 % ) ToothpasteSY1
891775sodium fluoride 0.243 % (fluoride ion 0.15 % ) ToothpasteSY1
891775sodium fluoride 0.243 % (fluoride ion 0.16 % ) ToothpasteSY1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71141-184-10dentalux Kids ANTI-CAVITY FLUORIDE Bubble Gum1 in 1 BOXPASTE, DENTIFRICE11
71141-184-10dentalux Kids ANTI-CAVITY FLUORIDE Bubble Gum113 g in 1 TUBEPASTE, DENTIFRICE1131

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71141-184DENTALUX KIDS ANTI-CAVITY FLUORIDE BUBBLE GUM (SODIUM FLUORIDE) PASTE, DENTIFRICE [LIDL US, LLC]1Current NDC, 2 package rows20241121_0c77ba33-acb9-4c83-aa75-7d5c82f903eb.zip

Products#

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

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71141-18471141-184-10

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Name, UNII, Kind table
NameUNIIKind
SODIUM FLUORIDE8ZYQ1474W7ACTIB
SORBITOL506T60A25RIACT
WATER059QF0KO0RIACT
HYDRATED SILICAY6O7T4G8P9IACT
POLYETHYLENE GLYCOL 16001212Z7S33AIACT
SODIUM LAURYL SULFATE368GB5141JIACT
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIEDK679OBS311IACT
BENZYL ALCOHOLLKG8494WBHIACT
SODIUM BENZOATEOJ245FE5EUIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
SODIUM PHOSPHATE, TRIBASIC, ANHYDROUSSX01TZO3QZIACT
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
SODIUM PYROPHOSPHATEO352864B8ZIACT
MICAV8A1AW0880IACT
TITANIUM DIOXIDE15FIX9V2JPIACT
FD&C BLUE NO. 1H3R47K3TBDIACT

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 Kids ANTI-CAVITY FLUORIDE Bubble GumSODIUM FLUORIDELidl US, LLC0c77ba33-acb9-4c83-aa75-7d5c82f903eb2024-07-02WarningsExact identifier
ndc (package): 71141-184-10
ndc (product): 71141-184
ndc11 (package): 71141018410
spl id: 27546687-6071-4e8b-bce4-217745919e95
spl set id: 0c77ba33-acb9-4c83-aa75-7d5c82f903eb

Reported adverse events (FAERS/openFDA)#

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