FDA.reportPublic FDA data

Dentalux 576.001/576AD

Manufacturer
Lidl US, LLC | Nice-Pak Products, LLC
Effective date
2026-09-16
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
daily-update
Hydrated at
2026-09-19 01:01:05

Label at a glance#

Productsodium fluoride
Active ingredientSODIUM FLUORIDE
Label structure13 sections

Dosage and administration

Adults and children 6 years of age and older: use twice a day after brushing your teeth with a toothpaste vigorously swish 10 mL (2 teaspoonfuls) of rinse between your teeth for 1 minute and then spit out do not swallow the rinse do not eat or drink for 30 minutes after rinsing instruct children under 12 years of age in good rinsing habits (to minimize swallowing) supervise children as necessary until capable of u...

Label contents#

Full prescribing information#

Claims

SPL UNCLASSIFIED SECTION

dentalux

REFRESHING MINT

MULTI-ACTION

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Sodium fluoride 0.02% (0.01% w/v fluoride ion)

Purpose

OTC - PURPOSE SECTION

Anticavity

Use

INDICATIONS & USAGE SECTION

aids in the prevention of dental cavities

Warnings

WARNINGS SECTION

for this product

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

Adults and children 6 years of age and older:

  • use twice a day after brushing your teeth with a toothpaste
  • vigorously swish 10 mL (2 teaspoonfuls) of rinse between your teeth for 1 minute and then spit out
  • do not swallow the rinse
  • do not eat or drink for 30 minutes after rinsing
  • instruct children under 12 years of age in good rinsing habits (to minimize swallowing)
  • supervise children as necessary until capable of using without supervision
  • children under 6 years of age: consult a dentist or doctor

Inactive ingredients

INACTIVE INGREDIENT SECTION

water, glycerin, flavor, cetylpyridinium chloride, sodium saccharin, phosphoric acid, sodium benzoate, sucralose, poloxamer 407, benzoic acid, disodium phosphate, propylene glycol, blue 1

Questions?

OTC - QUESTIONS SECTION

Call 1-844-344-5071

Disclaimers

SPL UNCLASSIFIED SECTION

This rinse may cause temporary staining to the surface of teeth.

This is not harmful, and adequate brushing may prevent its occurrence.

*This product is not manufactured or distributed by Procter and Gamble, distributor of Crest ® Pro-Health ® Advanced Anticavity Fluoride Mouthwash Multi-Protection Alcohol Free.

Adverse Reactions

ADVERSE REACTIONS SECTION

DISTRIBUTED BY LIDL US, LLC

3500 S. CLARK STREET, ARLINGTON, VA 22202

QUESTIONS? 1-844-344-5071 WWW.LIDL.COM

Lidl

PLASTIC BOTTLE

Widely Recyclable

Discard Seal, Empty & Replace Cap

how2recycle.info

Tamper Evident Statement

SPL UNCLASSIFIED SECTION

DO NOT USE IF SAFETY SEAL IS BROKEN OR MISSING.

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ALCOHOL FREE

dentalux

REFRESHING MINT

MULTI-ACTION

ANTICAVITY FLUORIDE MOUTHWASH

  • Helps strengthen enamel
  • Helps clean the entire mouth
  • Helps prevent cavities
  • Freshens breath
  • Kills bad breath germs
  • Helps keep mouth feeling clean

COMPARE TO Crest ® Pro-Health ® Advanced Alcohol Free MOUTHWASH*

IMPORTANT: READ DIRECTIONS FOR PROPER USE.

33.8 FL OZ (1.05 QT) 1 L

mm01mm01mm02mm02

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71141-57671141-576-86

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
NameUNIIKind
SODIUM FLUORIDE8ZYQ1474W7ACTIM
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
CETYLPYRIDINIUM CHLORIDED9OM4SK49PIACT
SODIUM SACCHARINSB8ZUX40TYIACT
PHOSPHORIC ACIDE4GA8884NNIACT
SODIUM BENZOATEOJ245FE5EUIACT
SUCRALOSE96K6UQ3ZD4IACT
POLOXAMER 407TUF2IVW3M2IACT
BENZOIC ACID8SKN0B0MIMIACT
DISODIUM PHOSPHATE22ADO53M6FIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
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 40 · 784 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
COLGATE OPTIC WHITE STAIN FIGHTER FRESH MINTSODIUM FLUORIDEColgate-Palmolive Companyb1ef8277-9919-453c-9d21-da4666d952de2026-09-17WarningsName fallback
generic name: SODIUM FLUORIDE
TheraBreathSODIUM FLUORIDEChurch & Dwight Co., Inc.53c1086d-264b-9d00-e063-6394a90ad19d2026-09-09WarningsName fallback
generic name: SODIUM FLUORIDE
Opalescence Whitening Cool MintSODIUM FLUORIDEUltradent Products, Inc.44e7d0ed-3c37-5889-e063-6294a90afcca2026-09-09WarningsName fallback
generic name: SODIUM FLUORIDE
Opalescence WhiteningSODIUM FLUORIDEUltradent Products, Incd07f842e-b6f1-4ae1-b576-f542ecd02dd42026-09-09WarningsName fallback
generic name: SODIUM FLUORIDE
Opal by Opalescence OriginalSODIUM FLUORIDEUltradent Products, Inc.5c3bf8fc-2e8f-4a58-bcbf-e47540072a492026-09-09WarningsName fallback
generic name: SODIUM FLUORIDE
Colgate MaxFresh KnockoutSODIUM FLUORIDEColgate-Palmolive Company0ffbb3a9-7bfa-4f6a-aef3-fde327a410c92026-09-09WarningsName fallback
generic name: SODIUM FLUORIDE
Colgate MaxFresh CharcoalSODIUM FLUORIDEColgate-Palmolive Companyde3674f4-3ce6-47d5-8391-6ad6789d68d92026-09-09WarningsName fallback
generic name: SODIUM FLUORIDE
Colgate Optic White Stain Fighter Sens ReliefSODIUM FLUORIDEColgate-Palmolive Company6ec2fff7-df44-4302-be2d-97946c6cd66a2026-09-08WarningsName fallback
generic name: SODIUM FLUORIDE
Freshmint Premium AnticavitySODIUM FLUORIDENew World Imports, Incef108fff-a79c-4e8d-8bf0-3fe567f93eb82026-09-08WarningsName fallback
generic name: SODIUM FLUORIDE
Freshmint Premium AnticavitySODIUM FLUORIDENew World Imports, Inc1a42cf2d-6c48-4e38-97bc-b6f2084bf39b2026-09-08WarningsName fallback
generic name: SODIUM FLUORIDE
Freshmint Premium Anticavity GelSODIUM FLUORIDENew World Imports, Incdfe564c1-2097-431d-93f0-cf423f2542482026-09-08WarningsName fallback
generic name: SODIUM FLUORIDE
BIO SPECTRA ATTITUDESODIUM FLUORIDE9055-7588 Qubec Inc. DBA Attitude54bd43c9-489d-4e6b-9031-90ec0e3c45162026-09-01WarningsName fallback
generic name: SODIUM FLUORIDE
BIO SPECTRA ATTITUDESODIUM FLUORIDE9055-7588 Qubec Inc. DBA Attitude53c344e9-49f5-48aa-8309-1e15f80b80a02026-09-01WarningsName fallback
generic name: SODIUM FLUORIDE
Listerine Total Care Fresh Mint AnticavitySODIUM FLUORIDEKenvue Brands LLCb2ce66c3-dc48-47a5-a731-5550bc1946792026-08-28WarningsName fallback
generic name: SODIUM FLUORIDE
Anticavity Fluoride RinseSODIUM FLUORIDEYour Military Exchangescef74e9c-d3b5-4e92-9908-187be97b63ab2026-08-28Warnings, Adverse reactionsName fallback
generic name: SODIUM FLUORIDE
Kids Flouride RinseSODIUM FLUORIDEYour Military Exchanges5f6f4125-6264-4724-bb7e-a6e100939b412026-08-28Warnings, Adverse reactionsName fallback
generic name: SODIUM FLUORIDE
Colgate MaxFresh Clean MintSODIUM FLUORIDEColgate-Palmolive Company7cb85fc4-573b-45d7-a430-f2fd17320c432026-08-26WarningsName fallback
generic name: SODIUM FLUORIDE
COLGATE 2IN1 ICY BLASTSODIUM FLUORIDEColgate-Palmolive Company6aad9a91-ba1c-4a27-9269-ea8032feaad02026-08-26WarningsName fallback
generic name: SODIUM FLUORIDE
Anticavity Fluoride RinseSODIUM FLUORIDENice-Pak Products, LLCc71d4064-f938-477b-9346-eb38be65390d2026-08-25Warnings, Adverse reactionsName fallback
generic name: SODIUM FLUORIDE
AIM Whitening with Baking SodaSODIUM FLUORIDEChurch & Dwight Co., Inc.1d0fd0b4-33ba-5764-e054-00144ff88e882026-08-25WarningsName fallback
generic name: SODIUM FLUORIDE

Reported adverse events (FAERS/openFDA)#

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