FDA.reportPublic FDA data

DIO WHITENING

Manufacturer
Dio Corporation | KMPharmaceutical Co., Ltd.
Effective date
2017-06-01
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 22:50:02

Label at a glance#

ProductDIO WHITENING
Active ingredientSILICON DIOXIDE, .ALPHA.-TOCOPHEROL ACETATE, HYDROGEN PEROXIDE
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

colloidal silicon dioxide, tocopherol acetate, 35% hydrogen peroxide solution


INACTIVE INGREDIENT SECTION

xylityl, sorbitol solution 70%, polyethylene glycol 1500, carboxymethylcellulose sodium, xanthan gum, poly vinyl pirrolidone, sodium stannate, etc.

OTC - PURPOSE SECTION

for dental care



OTC - KEEP OUT OF REACH OF CHILDREN SECTION

keep out of reach of the children

INDICATIONS & USAGE SECTION

brush teeth with your toothbrush



WARNINGS SECTION

store at room temperature


DOSAGE & ADMINISTRATION SECTION

for dental use only

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

package label
package label

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
5eb9f24b-9328-475e-af0a-18021935eb6aProduct name120180220

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
75902-4001-12020-01-31C16284748780-19d75b9d0-2983-f424-e053-dadaa90a57ceDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
75902-4001-1DIO WHITENING90 g in 1 BOTTLE, PUMPPASTE, DENTIFRICE902

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
75902-4001DIO WHITENING (SODIUM FLUORIDE) PASTE, DENTIFRICE [DIO CORPORATION]2Legacy NDC, 1 package rows20170605_1b5a5f59-fa6a-4ce6-a360-502fb651eb1a.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
.ALPHA.-TOCOPHEROL ACETATEACTIVE INGREDIENT9E8X80D2L01
HYDROGEN PEROXIDEACTIVE INGREDIENTBBX060AN9V1
SILICON DIOXIDEACTIVE INGREDIENTETJ7Z6XBU41
.ALPHA.-TOCOPHEROLACTIVE MOIETYH4N855PNZ11
HYDROGEN PEROXIDEACTIVE MOIETYBBX060AN9V1
SILICON DIOXIDEACTIVE MOIETYETJ7Z6XBU41
WATERINACTIVE INGREDIENT059QF0KO0R1
XYLITOLINACTIVE INGREDIENTVCQ006KQ1E1

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
75902-400175902-4001-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
NameUNIIKind
XYLITOLVCQ006KQ1EIACT
WATER059QF0KO0RIACT
SILICON DIOXIDEETJ7Z6XBU4ACTIB
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0ACTIM
HYDROGEN PEROXIDEBBX060AN9VACTIB

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 · 12 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
XYLITOLXYLITOLVCQ006KQ1ETABLET, FILM COATED, EXTENDED RELEASE / ORAL72 mgExact identifier — unii candidate
12 equally ranked IID candidates
XYLITOLXYLITOLVCQ006KQ1EPASTE / ORAL180 mgExact identifier — unii candidate
12 equally ranked IID candidates
XYLITOLXYLITOLVCQ006KQ1ESUSPENSION / ORAL1500 mgExact identifier — unii candidate
12 equally ranked IID candidates
XYLITOLXYLITOLVCQ006KQ1ETABLET / ORAL15.04 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
XYLITOLXYLITOLVCQ006KQ1EFILM, SOLUBLE / ORAL29 mgExact identifier — unii candidate
12 equally ranked IID candidates
XYLITOLXYLITOLVCQ006KQ1ESUSPENSION, EXTENDED RELEASE / ORAL9000 mgExact identifier — unii candidate
12 equally ranked IID candidates
XYLITOLXYLITOLVCQ006KQ1EPOWDER, FOR SUSPENSION / ORAL4223 mgExact identifier — unii candidate
12 equally ranked IID candidates
XYLITOLXYLITOLVCQ006KQ1ESPRAY / SUBLINGUAL22 mgExact identifier — unii candidate
12 equally ranked IID candidates
XYLITOLXYLITOLVCQ006KQ1EGUM, CHEWING / BUCCAL11915 mgExact identifier — unii candidate
12 equally ranked IID candidates
XYLITOLXYLITOLVCQ006KQ1ETABLET, EXTENDED RELEASE / ORAL2752 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
50e23c08-7305-6d1a-e054-00144ff8d46c1b5a5f59-fa6a-4ce6-a360-502fb651eb1a2017-06-01WarningsExact identifier
spl id: 50e23c08-7305-6d1a-e054-00144ff8d46c
spl set id: 1b5a5f59-fa6a-4ce6-a360-502fb651eb1a

Reported adverse events (FAERS/openFDA)#

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