FDA.reportPublic FDA data

Equate Anticavity Oral Rinse

Manufacturer
Wal-Mart Stores, Inc.
Effective date
2023-01-06
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-05-31 23:52:59

Label at a glance#

ProductEquate Anticavity Oral Rinse
Active ingredientSODIUM FLUORIDE
Label structure11 sections

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredient

Sodium fluoride 0.021%

(0.01% w/v fluoride ion)

OTC - PURPOSE SECTION

Purpose

Anticavity

INDICATIONS & USAGE SECTION

Use aids in the prevention of dental cavities

WARNINGS SECTION

Warnings

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children under 6 years of age. If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION SECTION

Directions

  • Adults and children 6 years 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 childrenas necessary until capable of using without supervision
  • children under 6 years of age: consult a dentist or doctor

INACTIVE INGREDIENT SECTION

Inactive ingredients water, glycerin, flavor, cetylpyridinium chloride, poloxamer 407, phosphoric acid, methylparaben, sodium saccharin, propylparaben, propylene glycol, disodium phosphate, red 33, green3

OTC - QUESTIONS SECTION

Questions? Call 1-888-287-1915

SPL UNCLASSIFIED SECTION

DISTRIBUTED BY: Wal-Mart Stores, Inc., Bentonville, AR 72716

PRODUCT OF CANADA

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

equate™

Anticavity Oral Rinse

Multi-Action with Fluoride

33.8 FL OZ (1L)

Anticavity Oral RinseAnticavity Oral Rinse

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
49035-535-862025-01-30C16284748780-1c7ccaba7-24db-fd44-e053-dadaa90aa01bEquate Anticavity Oral Rinse
49035-535-862021-08-23C16284748780-1c7ccaba7-24db-fd44-e053-dadaa90aa01bEquate Anticavity Oral Rinse
49035-535-862021-07-23C16284748780-1c7ccaba7-24db-fd44-e053-dadaa90aa01bEquate Anticavity Oral Rinse

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49035-535-86Equate Anticavity Oral Rinse1000 mL in 1 BOTTLE, PLASTICLIQUID10004

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49035-535EQUATE ANTICAVITY ORAL RINSE (FLUORIDE) LIQUID [WAL-MART STORES, INC.]4Legacy NDC, 1 package rows20230107_45739013-5581-12bb-e054-00144ff88e88.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
49035-53549035-535-86

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
D&C RED NO. 339DBA0SBB0LIACT
FD&C RED NO. 3PN2ZH5LOQYIACT
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
CETYLPYRIDINIUM CHLORIDED9OM4SK49PIACT
POLOXAMER 407TUF2IVW3M2IACT
PHOSPHORIC ACIDE4GA8884NNIACT
METHYLPARABENA2I8C7HI9TIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
PROPYLPARABENZ8IX2SC1OHIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
SODIUM PHOSPHATE, DIBASICGR686LBA74IACT
SODIUM FLUORIDE8ZYQ1474W7ACTIM

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
f19e44c8-fb9c-57a7-e053-2a95a90afd7a45739013-5581-12bb-e054-00144ff88e882023-01-06WarningsExact identifier
spl id: f19e44c8-fb9c-57a7-e053-2a95a90afd7a
spl set id: 45739013-5581-12bb-e054-00144ff88e88

Reported adverse events (FAERS/openFDA)#

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