FDA.reportPublic FDA data

Anticavity

Manufacturer
Meijer, Inc. | Nice-Pak Products, LLC
Effective date
2026-02-19
Label type
HUMAN OTC DRUG LABEL
Version
12
Source
full-release
Hydrated at
2026-06-01 01:46:40

Label at a glance#

ProductAnticavity
Active ingredientSODIUM FLUORIDE
Label structure12 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#

Tamper Evident Statement

OTHER SAFETY INFORMATION

SEALED WITH PRINTED NECKBAND FOR YOUR PROTECTION

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Sodium fluoride 0.02% (0.009% 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, alcohol (11%), sorbitol, poloxamer 407, propylene glycol, sodium benzoate, flavor, sodium phosphate, polysorbate 20, sodium saccharin, cetylpyridinium chloride, disodium phosphate, calcium disodium EDTA, blue 1

Questions?

OTC - QUESTIONS SECTION

Call 1-888-593-0593

Disclaimer

SPL UNCLASSIFIED SECTION

*This product is not manufactured or distributed by Chattem, Inc., distributor of Act ® Restoring Anticavity Fluoride Mouthwash Cool Mint.

ADVERSE REACTION

ADVERSE REACTIONS SECTION

DISTRIBUTED BY

MEIJER DISTRIBUTION, INC.

GRAND RAPIDS, MI 49544

www.meijer.com

OUR QUALITY GUARANTEE

The Meijer Family

WWW.MEIJER.COM/sATISFACTION

DSP-TN-21091

DSP-MO-20087

Principal display panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 41250-581-86

meijer ®

Compare to Act ® Restoring Anticavity Fluoride Mouthwash Active Ingredient*

RESTORING ANTICAVITY

Fluoride Rinse

Sodium Fluoride And Acidulated Phosphate Topical Solution

RESTORES ENAMEL

Refreshing Mint

Helps strengthen teeth

Helps remineralize soft spots

Freshens breath

IMPORTANT: Read directions for proper use

33.8 FL OZ (1 L) 1.05 QT

image descriptionimage descriptionimage descriptionimage description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
313029sodium fluoride 0.02 % (fluoride ion 0.01 % ) Oral RinsePSN12
313029sodium fluoride 0.2 MG/ML MouthwashSCD12
313029sodium fluoride 0.02 % (fluoride ion 0.009 % ) Oral RinseSY12
313029sodium fluoride 0.02 % (fluoride ion 0.01 % ) Oral RinseSY12

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
41250-581-86Anticavity1000 mL in 1 BOTTLE, PLASTICMOUTHWASH100012

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
41250-58141250-581-86

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
CETYLPYRIDINIUM CHLORIDED9OM4SK49PIACT
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS22ADO53M6FIACT
EDETATE CALCIUM DISODIUM ANHYDROUS8U5D034955IACT
FD&C BLUE NO. 1H3R47K3TBDIACT
SODIUM FLUORIDE8ZYQ1474W7ACTIB
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MIACT
SORBITOL506T60A25RIACT
POLOXAMER 407TUF2IVW3M2IACT
PROPYLENE GLYCOL6DC9Q167V3IACT
SODIUM BENZOATEOJ245FE5EUIACT
SODIUM PHOSPHATESE337SVY37IACT
POLYSORBATE 207T1F30V5YHIACT
SACCHARIN SODIUMSB8ZUX40TYIACT

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
AnticavitySODIUM FLUORIDEMeijer, Inc.acff939e-e98c-4d89-a0c4-0254dc74e6722026-02-19Warnings, Adverse reactionsExact identifier
ndc (package): 41250-581-86
ndc (product): 41250-581
ndc11 (package): 41250058186
spl id: 4b3400ba-8400-8aea-e063-6394a90a80cc
spl set id: acff939e-e98c-4d89-a0c4-0254dc74e672

Reported adverse events (FAERS/openFDA)#

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