FDA.reportPublic FDA data

Dr. Whitiss (8.3%)

Manufacturer
Nibec Co., Ltd
Effective date
2017-11-27
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 22:53:06

Label at a glance#

ProductDr. Whitiss (8.3%)
Active ingredientCARBAMIDE PEROXIDE
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

carbamide peroxide


INACTIVE INGREDIENT SECTION

polyvinyl pyrrolidone (k=90), glycerin, anhydrous ethyl alcohol, distilled water, potassium dihydrogen phosphate, sodium hydroxide, lemon oil, orange oil, xylitol, l-menthol, potassium nitrate, propolis ext


OTC - PURPOSE SECTION

whitening of discolored vital teeth


OTC - KEEP OUT OF REACH OF CHILDREN SECTION

keep out of reach of the children


INDICATIONS & USAGE SECTION

apply 2 or 3 times per day for 2 weeks for a brighter, whiter smile



WARNINGS SECTION

1) do not use on patient with sensitive to carbamide peroxide
2) do not use on patient with oral infection
3) no to be used by pregnant or lactating women or children under 18 years old
4) to be used under the supervision of a dentist
5) do not swallow this medication


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
47649-9001-12024-01-30C16284748780-11030e365-2da7-111a-e063-dadaa90a10e2Drug Facts
47649-9001-32024-01-30C16284748780-11030e365-2da7-111a-e063-dadaa90a10e2Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
47649-9001-1Dr. Whitiss (8.3%)5 g in 1 PACKAGEGEL, DENTIFRICE53
47649-9001-2Dr. Whitiss (8.3%)2 g in 1 CYLINDERGEL, DENTIFRICE23
47649-9001-3Dr. Whitiss (8.3%)4 in 1 PACKAGEGEL, DENTIFRICE43

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
47649-9001DR. WHITISS (8.3%) (CARBAMIDE PEROXIDE) GEL, DENTIFRICE [NIBEC CO., LTD]3Legacy NDC, 3 package rows20171128_1f4d7ad3-433c-40b3-842e-73a327214d86.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
CARBAMIDE PEROXIDEACTIVE INGREDIENT31PZ2VAU811
HYDROGEN PEROXIDEACTIVE MOIETYBBX060AN9V1
glycerinINACTIVE INGREDIENTPDC6A3C0OX1
POTASSIUM NITRATEINACTIVE INGREDIENTRU45X2JN0Z1
POVIDONE K90INACTIVE INGREDIENTRDH86HJV5Z1
waterINACTIVE INGREDIENT059QF0KO0R1

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
47649-900147649-9001-2, 47649-9001-3, 47649-9001-1

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
POVIDONE K90RDH86HJV5ZIACT
GLYCERINPDC6A3C0OXIACT
WATER059QF0KO0RIACT
POTASSIUM NITRATERU45X2JN0ZIACT
CARBAMIDE PEROXIDE31PZ2VAU81ACTIB

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 2 · 94 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
POVIDONE K90POVIDONE K90RDH86HJV5ZSUSPENSION / ORAL2 mgExact identifier — unii candidate
19 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXCONCENTRATE / ORAL1800 mgExact identifier — unii candidate
75 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS225 mgExact identifier — unii candidate
75 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXSUSPENSION / OPHTHALMIC58 mgExact identifier — unii candidate
75 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXCREAM / TOPICAL1720 mgExact identifier — unii candidate
75 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXINJECTION, SUSPENSION / SUBCUTANEOUS1.6 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXCLOTH / TOPICAL0.05 mg/mgExact identifier — unii candidate
75 equally ranked IID candidates
POVIDONE K90POVIDONE K90RDH86HJV5ZTABLET, FILM COATED / ORAL128 mgExact identifier — unii candidate
19 equally ranked IID candidates
POVIDONE K90POVIDONE K90RDH86HJV5ZSOLUTION / TOPICAL120 mgExact identifier — unii candidate
19 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXEMULSION / INTRAVENOUS2.2 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXINJECTION / INTRAMUSCULAR450 mgExact identifier — unii candidate
75 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXSOLUTION / RESPIRATORY (INHALATION)5 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXSOLUTION / AURICULAR (OTIC)63.64 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXJELLY / TOPICALNAExact identifier — unii candidate
75 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXINJECTION, SOLUTION / INTRAMUSCULAR15 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXAEROSOL / TOPICAL3 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXSUSPENSION, EXTENDED RELEASE / ORAL2000 mgExact identifier — unii candidate
75 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXFILM, EXTENDED RELEASE / TRANSDERMAL306.2 mgExact identifier — unii candidate
75 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXSPRAY, METERED / NASAL13 mgExact identifier — unii candidate
75 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXLIQUID / TOPICAL2.5 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXOINTMENT / TOPICALNAExact identifier — unii candidate
75 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXSYSTEM / IONTOPHORESIS168.1 mgExact identifier — unii candidate
75 equally ranked IID candidates
POVIDONE K90POVIDONE K90RDH86HJV5ZTABLET, COATED / ORAL9.77 mgExact identifier — unii candidate
19 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXCAPSULE, LIQUID FILLED / ORAL185 mgExact identifier — unii candidate
75 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXAEROSOL, FOAM / TOPICAL21 mgExact identifier — unii candidate
75 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXCREAM, AUGMENTED / TOPICAL55 mgExact identifier — unii candidate
75 equally ranked IID candidates
POVIDONE K90POVIDONE K90RDH86HJV5ZTABLET, EXTENDED RELEASE / ORAL498 mgExact identifier — unii candidate
19 equally ranked IID candidates
POVIDONE K90POVIDONE K90RDH86HJV5ZSOLUTION/ DROPS / OPHTHALMIC1.2 %w/wExact identifier — unii candidate
19 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXSUSPENSION/ DROPS / OPHTHALMIC2.5 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXINJECTION / INTRADERMAL1.6 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
POVIDONE K90POVIDONE K90RDH86HJV5ZSOLUTION / OPHTHALMIC0.3 %w/vExact identifier — unii candidate
19 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXDOUCHE / VAGINAL1 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXINJECTION / SUBCUTANEOUS450 mgExact identifier — unii candidate
75 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXGUM, CHEWING / BUCCAL230 mgExact identifier — unii candidate
75 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXSOLUTION / TOPICAL1971 mgExact identifier — unii candidate
75 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXSOLUTION / ORAL32400 mgExact identifier — unii candidate
75 equally ranked IID candidates
POVIDONE K90POVIDONE K90RDH86HJV5ZSOLUTION/ DROPS / AURICULAR (OTIC)2 mgExact identifier — unii candidate
19 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXTABLET / PERIODONTAL0.53 mgExact identifier — unii candidate
75 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXSOLUTION / DENTAL15 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
POVIDONE K90POVIDONE K90RDH86HJV5ZTABLET / ORAL966 mgExact identifier — unii candidate
19 equally ranked IID candidates
POVIDONE K90POVIDONE K90RDH86HJV5ZCAPSULE / ORAL270 mgExact identifier — unii candidate
19 equally ranked IID candidates
POVIDONE K90POVIDONE K90RDH86HJV5ZTABLET, DELAYED RELEASE / ORAL192 mgExact identifier — unii candidate
19 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXTABLET, CHEWABLE / ORAL12 mgExact identifier — unii candidate
75 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXSYSTEM / TOPICAL18144 mgExact identifier — unii candidate
75 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXFILM, EXTENDED RELEASE / BUCCAL34 mgExact identifier — unii candidate
75 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXINJECTION, SOLUTION / INTRAVENOUS15 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXCAPSULE / ORAL3487 mgExact identifier — unii candidate
75 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXSUSPENSION / AURICULAR (OTIC)0.05 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXSUSPENSION/ DROPS / ORAL750 mgExact identifier — unii candidate
75 equally ranked IID candidates
POVIDONE K90POVIDONE K90RDH86HJV5ZSYSTEM / TOPICAL280 mgExact identifier — unii candidate
19 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXGEL / TRANSDERMAL500 mgExact identifier — unii candidate
75 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXEMULSION / OPHTHALMIC3 mgExact identifier — unii candidate
75 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXINJECTION, EMULSION / INTRAVENOUS24100 mgExact identifier — unii candidate
75 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXINJECTION, SOLUTION / SUBCUTANEOUS15 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXSUSPENSION / ORAL26208 mgExact identifier — unii candidate
75 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXLIQUID / ORAL2400 mgExact identifier — unii candidate
75 equally ranked IID candidates
POVIDONE K90POVIDONE K90RDH86HJV5ZSUSPENSION / OPHTHALMIC4 mgExact identifier — unii candidate
19 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXSUPPOSITORY / VAGINAL227.9 mgExact identifier — unii candidate
75 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXPASTE / DENTAL20 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
glycerinGLYCERINPDC6A3C0OXELIXIR / ORAL5621 mgExact identifier — unii candidate
75 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
5f0112bb-31bf-d5c1-e053-2a91aa0a44d51f4d7ad3-433c-40b3-842e-73a327214d862017-11-27WarningsExact identifier
spl id: 5f0112bb-31bf-d5c1-e053-2a91aa0a44d5
spl set id: 1f4d7ad3-433c-40b3-842e-73a327214d86

Reported adverse events (FAERS/openFDA)#

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