FDA.reportPublic FDA data

Assured Anticavity Fluoride Kids Bubblegum

Manufacturer
Greenbrier International, Inc.
Effective date
2021-08-23
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:42:02

Label at a glance#

ProductAssured Anticavity Fluoride Kids Bubblegum
Active ingredientSODIUM FLUORIDE
Label structure10 sections

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients

Sodium fluoride 0.05% (Fluoride ion-0.0226%)

OTC - PURPOSE SECTION

Purpose

Anticavity rinse

INDICATIONS & USAGE SECTION

Use aids in the prevention of dental cavities.

WARNINGS SECTION

Warning

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center immediately.

DOSAGE & ADMINISTRATION SECTION

Directions

  • adults and children 6 years of age and older, use once a day after brushing your teeth with a toothpaste
  • remove cap
  • use approximately one tablespoon and rinse vigorously 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
  • supervise children as necessary until capable of using without supervision
  • children under 6 years of age: consult a dentist or doctor

INACTIVE INGREDIENT SECTION

Inactive ingredients Benzyl Alcohol, Calcium disodium EDTA, Cetylpyridinium Chloride, Disodium Phosphate, Flavor, Poloxamer 407, Polysorbate 80, Propylene Glycol, Red 33, Sodium Benzoate, Sodium Phosphate, Sodium Saccharin, Sorbitol, Water

SPL UNCLASSIFIED SECTION

Other information

  • Store at room temperature

SPL UNCLASSIFIED SECTION

*Anticavity Fluoride Rinse is not manufactured or distributed by Personal Products Company division or McNeil-PPC., distributor or Act®

DISTRIBUTED BY GREENBRIER INTERNATIONAL, INC.

CHESAPEAKE, VA 23320

MADE IN CANADA

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ASSURED™

Compare to ACT® active ingredient*

Kids Anticavity

Fluoride Rinse
BUBBLEGUM

ALCOHOL FREE

CAVITY PROTECTION
18 FL. OZ. (532 mL)

Kids Anticavity Fluoride RinseKids Anticavity Fluoride Rinse

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
240698sodium fluoride 0.05 % (fluoride ion 0.02 % ) Oral RinsePSN3
240698sodium fluoride 0.5 MG/ML MouthwashSCD3
240698sodium fluoride 0.05 % (fluoride ion 0.02 % ) Oral RinseSY3

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
33992-0015-72023-01-30C16284748780-1c7ccaba7-2850-fd44-e053-dadaa90aa01bAssured Kids Anticavity Fluoride Rinse Bubblegum
33992-0015-72021-08-23C16284748780-1c7ccaba7-2850-fd44-e053-dadaa90aa01bAssured Kids Anticavity Fluoride Rinse Bubblegum
33992-0015-72021-07-23C16284748780-1c7ccaba7-2850-fd44-e053-dadaa90aa01bAssured Kids Anticavity Fluoride Rinse Bubblegum

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
33992-0015-7Assured Anticavity Fluoride Kids Bubblegum532 mL in 1 BOTTLE, PLASTICRINSE5323

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
33992-0015ASSURED ANTICAVITY FLUORIDE KIDS BUBBLEGUM (SODIUM FLUORIDE) RINSE [GREENBRIER INTERNATIONAL, INC.]3Legacy NDC, 1 package rows20210824_8802c26b-47e2-cb92-e053-2995a90a63da.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
33992-001533992-0015-7

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
SODIUM PHOSPHATESE337SVY37IACT
BENZYL ALCOHOLLKG8494WBHIACT
EDETATE CALCIUM DISODIUM ANHYDROUS8U5D034955IACT
CETYLPYRIDINIUM CHLORIDED9OM4SK49PIACT
POLOXAMER 407TUF2IVW3M2IACT
POLYSORBATE 806OZP39ZG8HIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
D&C RED NO. 339DBA0SBB0LIACT
SODIUM BENZOATEOJ245FE5EUIACT
SODIUM PHOSPHATE DIBASIC DIHYDRATE94255I6E2TIACT
SACCHARIN SODIUMSB8ZUX40TYIACT
SORBITOL506T60A25RIACT
WATER059QF0KO0RIACT
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
ca3f18b5-792b-1077-e053-2a95a90a6ca08802c26b-47e2-cb92-e053-2995a90a63da2021-08-23WarningsExact identifier
spl id: ca3f18b5-792b-1077-e053-2a95a90a6ca0
spl set id: 8802c26b-47e2-cb92-e053-2995a90a63da

Reported adverse events (FAERS/openFDA)#

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