FDA.reportPublic FDA data

Aquapick Whitening Tooth Foam

Manufacturer
Aquapick Co., Ltd
Effective date
2015-10-26
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:43:55

Label at a glance#

ProductAquapick Whitening Tooth Foam
Active ingredientSODIUM FLUORIDE
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

sodium fluoride


INACTIVE INGREDIENT SECTION

allantoin, xylitol, greentea extract, sage extract, chamomile extract, grapefruit seed extract


OTC - PURPOSE SECTION

Clean and maintain the aesthetics and health of teeth including but not warranted to the prevention of gingival and periodontal disease

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

keep out of reach of the children


INDICATIONS & USAGE SECTION

brush with toothbrush and rinse thoroughly



WARNINGS SECTION

- Children under the age of 6 should be accompanied by an adult when using this product and should use no more than a pea-sized amount. If over consumption occurs, please contact a qualified medical professional immediately.
- Avoid sucking or swallowing.
- For oral hygiene purposes only.
- If any side effects occur, please contact a qualified medical or dental professional immediately.



DOSAGE & ADMINISTRATION SECTION

for dental use only


PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

package insert
package insert

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
58399-2001-12020-01-31C16284748780-19d75b9d0-a6de-f424-e053-dadaa90a57ceDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58399-2001-1Aquapick Whitening Tooth Foam50 mL in 1 BOTTLE, PLASTICLIQUID501

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58399-2001AQUAPICK WHITENING TOOTH FOAM (SODIUM FLUORIDE) LIQUID [AQUAPICK CO., LTD]1Legacy NDC, 1 package rows20151027_760a6858-5f75-4047-b1b1-28c0dcdf8d2e.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
SODIUM FLUORIDEACTIVE INGREDIENT8ZYQ1474W71
FLUORIDE IONACTIVE MOIETYQ80VPU408O1
ALLANTOININACTIVE INGREDIENT344S277G0Z1
CHAMOMILEINACTIVE INGREDIENTFGL3685T2X1
GRAPEFRUITINACTIVE INGREDIENTO82C39RR8C1
GREEN TEA LEAFINACTIVE INGREDIENTW2ZU1RY8B01
SAGEINACTIVE INGREDIENT065C5D077J1
XYLITOLINACTIVE INGREDIENTVCQ006KQ1E1

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
58399-200158399-2001-1

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
ALLANTOIN344S277G0ZIACT
XYLITOLVCQ006KQ1EIACT
GREEN TEA LEAFW2ZU1RY8B0IACT
SAGE065C5D077JIACT
CHAMOMILEFGL3685T2XIACT
GRAPEFRUITO82C39RR8CIACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 13 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
XYLITOLXYLITOLVCQ006KQ1EPASTE / ORAL180 mgExact identifier — unii candidate
12 equally ranked IID candidates
XYLITOLXYLITOLVCQ006KQ1EFILM, SOLUBLE / ORAL29 mgExact identifier — unii candidate
12 equally ranked IID candidates
XYLITOLXYLITOLVCQ006KQ1ETABLET, FILM COATED, EXTENDED RELEASE / ORAL72 mgExact identifier — unii candidate
12 equally ranked IID candidates
XYLITOLXYLITOLVCQ006KQ1EGUM, CHEWING / BUCCAL11915 mgExact identifier — unii candidate
12 equally ranked IID candidates
XYLITOLXYLITOLVCQ006KQ1ESPRAY / SUBLINGUAL22 mgExact identifier — unii candidate
12 equally ranked IID candidates
XYLITOLXYLITOLVCQ006KQ1ETABLET, ORALLY DISINTEGRATING / ORAL360 mgExact identifier — unii candidate
12 equally ranked IID candidates
XYLITOLXYLITOLVCQ006KQ1ESOLUTION / ORAL21600 mgExact identifier — unii candidate
12 equally ranked IID candidates
XYLITOLXYLITOLVCQ006KQ1ETABLET / ORAL15.04 mgExact identifier — unii candidate
12 equally ranked IID candidates
XYLITOLXYLITOLVCQ006KQ1EPOWDER, FOR SUSPENSION / ORAL4223 mgExact identifier — unii candidate
12 equally ranked IID candidates
XYLITOLXYLITOLVCQ006KQ1ESUSPENSION / ORAL1500 mgExact identifier — unii candidate
12 equally ranked IID candidates
ALLANTOINALLANTOIN344S277G0ZGEL / TOPICAL8 mgExact identifier — unii candidate
XYLITOLXYLITOLVCQ006KQ1ETABLET, EXTENDED RELEASE / ORAL2752 mgExact identifier — unii candidate
12 equally ranked IID candidates
XYLITOLXYLITOLVCQ006KQ1ESUSPENSION, EXTENDED RELEASE / ORAL9000 mgExact identifier — unii candidate
12 equally ranked IID candidates

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
1c95109f-ac5d-49dc-bc5a-52a16d75d074760a6858-5f75-4047-b1b1-28c0dcdf8d2e2015-10-26WarningsExact identifier
spl id: 1c95109f-ac5d-49dc-bc5a-52a16d75d074
spl set id: 760a6858-5f75-4047-b1b1-28c0dcdf8d2e

Reported adverse events (FAERS/openFDA)#

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