FDA.reportPublic FDA data

Kroger Kids Anticavity Fluoride

Manufacturer
The Kroger Company | Apollo Health and Beauty Care Inc.
Effective date
2017-01-23
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:48:37

Label at a glance#

ProductKroger Kids Anticavity Fluoride Mixed Berry
Active ingredientSODIUM FLUORIDE
Label structure8 sections

Dosage and administration

​Adults and children 6 years of age and older: ​use twice daily 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...

Storage and handling

Store at controlled room temperature 20°-25°C (68°-77°F) Cold weather may cloud this product.

Label contents#

Full prescribing information#

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

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 immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

  • ​Adults and children 6 years of age and older:
  • ​use twice daily 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

Other information

STORAGE AND HANDLING SECTION

  • Store at controlled room temperature 20°-25°C (68°-77°F)
  • Cold weather may cloud this product.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water (Aqua), Xylitol, Glycerin, Zinc Chloride, Benzoic Acid, Flavor (Aroma), Methylparaben.

Questions or Comments?

OTC - QUESTIONS SECTION

1-800-632-6900

Label Copy

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of the labelImage of the label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
313029sodium fluoride 0.02 % (fluoride ion 0.01 % ) Oral RinsePSN1
313029sodium fluoride 0.2 MG/ML MouthwashSCD1
313029sodium fluoride 0.02 % (fluoride ion 0.009 % ) Oral RinseSY1
313029sodium fluoride 0.02 % (fluoride ion 0.01 % ) Oral RinseSY1

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130041260379635GTIN-13: 0041260379635
EAN-13: 0041260379635
GTIN-12: 041260379635
UPC-A: 041260379635
GTIN storage (14 digits): 00041260379635		21558L.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
30142-563-162024-01-30C16284748780-11030e365-200f-111a-e063-dadaa90a10e2Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
30142-563-16Kroger Kids Anticavity FluorideMixed Berry500 mL in 1 BOTTLE, PLASTICLIQUID5001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
30142-563KROGER KIDS ANTICAVITY FLUORIDE MIXED BERRY (SODIUM FLUORIDE) LIQUID [THE KROGER COMPANY]1Legacy NDC, 1 package rows20170123_b409c574-67d5-445c-a015-25cf543cb6e4.zip

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
30142-56330142-563-16

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
SODIUM FLUORIDE8ZYQ1474W7ACTIM
WATER059QF0KO0RIACT
XYLITOLVCQ006KQ1EIACT
GLYCERINPDC6A3C0OXIACT
ZINC CHLORIDE86Q357L16BIACT
BENZOIC ACID8SKN0B0MIMIACT
METHYLPARABENA2I8C7HI9TIACT

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
b37f34ae-da59-455f-b879-83bd0f1adb63b409c574-67d5-445c-a015-25cf543cb6e42017-01-23WarningsExact identifier
spl id: b37f34ae-da59-455f-b879-83bd0f1adb63
spl set id: b409c574-67d5-445c-a015-25cf543cb6e4

Reported adverse events (FAERS/openFDA)#

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