FDA.reportPublic FDA data

KeriCleanz ANTISEPTIC

Product NDC
78280-401
11-digit product format
782800401
Labeler code
78280
Product ID
78280-401_1236303c-b046-4185-8e10-11c4893cd120
Type
HUMAN OTC DRUG
Nonproprietary name
Hydrogen Peroxide
Dosage form
SPRAY
Route
TOPICAL
Labeler
Kericure Inc.
Application
M003
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-10-11
Substance
HYDROGEN PEROXIDE
Active strength
1 mL/100mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
KeriCleanz ANTISEPTIC
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HYDROGEN PEROXIDE1 mL/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
BBX060AN9VInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
79b0d9bb-0fa5-4e45-ab74-9ff0e1215238Available on FDA.report

DailyMed Product Concepts#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
78280-401-05KeriCleanz ANTISEPTIC17 mL in 1 BOTTLE, SPRAYSPRAY173
78280-401-10KeriCleanz ANTISEPTIC28 mL in 1 BOTTLE, SPRAYSPRAY283

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
78280-401KERICLEANZ ANTISEPTIC (HYDROGEN PEROXIDE) SPRAY [KERICURE INC.]2Current NDC, 2 package rows20250108_79b0d9bb-0fa5-4e45-ab74-9ff0e1215238.zip

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 23 of 115 · 2,286 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Redicare Alcohol Prep PadsMEDIUM ALCOHOL PREP PADSRedicare LLC3cb7fba1-1d2d-f4da-e063-6394a90a4b212026-05-01WarningsExact identifier
application number: M003
SCOTT Antiseptic Foam Skin CleanserCHLOROXYLENOLKimberly-Clarkca761935-7dcc-4caf-b941-60693a97c8a62026-04-30WarningsExact identifier
application number: M003
SCOTT FOAM HAND SANITIZERBENZALKONIUM CHLORIDEKimberly-Clark11234f21-04e4-4b16-88c3-51968a1cedca2026-04-30WarningsExact identifier
application number: M003
First Aid AntisepticPOVIDONE-IODINERetail Business Services, LLCad4e49b6-5784-4880-950b-6e6175fc312b2026-04-30Warnings, Adverse reactionsExact identifier
application number: M003
70%ISOPROPYL ALCOHOLYour Military Exchanges3dcb8422-827d-479b-ba18-eee8dbb762e12026-04-30Warnings, Adverse reactionsExact identifier
application number: M003
Hydrogen PeroxideHYDROGEN PEROXIDETarget Corporation33591569-8c56-4721-9d14-d9696f93c7932026-04-30Warnings, Adverse reactionsExact identifier
application number: M003
Oopsie 3 Hydrogen PeroxideHYDROGEN PEROXIDE4 Visions LLC50b0d82a-da2c-5fd0-e063-6294a90aa1652026-04-30WarningsExact identifier
application number: M003
Vita Vie Antibacterial WashBENZALKONIUM CHLORIDESpa De Soleila83883b7-9b63-641b-e053-2995a90ab9432026-04-30WarningsExact identifier
application number: M003
Dr Lift Advanced Antibacterial WipesBENZALKONIUM CHLORIDESpa de Soleilaf89bd25-784e-4828-e053-2995a90a8aaa2026-04-30WarningsExact identifier
application number: M003
Dr Lift Antibacterial Hand WashBENZALKONIUM CHLORIDESpa de Soleilab9e2c3c-d422-255e-e053-2a95a90a7a222026-04-30WarningsExact identifier
application number: M003
Dr Lift Antibacterial Body ScrubBENZALKONIUM CHLORIDESpa de Soleilab9d6c73-29c1-036a-e053-2995a90a449c2026-04-30WarningsExact identifier
application number: M003
KLEENEX Foam Hand SanitizerBENZALKONIUM CHLORIDEKimberly-Clark1fa77ae2-b652-463d-8943-d338c591226e2026-04-29WarningsExact identifier
application number: M003
Ethyl Rubbing AlcoholETHYL ALCOHOLYour Military Exchanges3dce175c-f893-4cfc-b495-6c11f2b77b872026-04-29Warnings, Adverse reactionsExact identifier
application number: M003
Hydrogen PeroxideHYDROGEN PEROXIDERetail Business Services, LLC2cc09239-a1d4-4276-adc4-82fdc396e23a2026-04-29Warnings, Adverse reactionsExact identifier
application number: M003
Isopropyl AlcoholISOPROPYL ALCOHOLPerrigo Direct, Inc11d89d11-103e-4ef6-a996-65cff67f9b322026-04-29Warnings, Adverse reactionsExact identifier
application number: M003
Isopropyl AlcoholISOPROPYL ALCOHOLWalmart Inc.1fd3d29f-7da0-c5ba-e063-6294a90add162026-04-29Warnings, Adverse reactionsExact identifier
application number: M003
Ethyl AlcoholETHYL ALCOHOLWalmart Inc.1fd3bed0-8fcc-2cee-e063-6294a90a34fb2026-04-29Warnings, Adverse reactionsExact identifier
application number: M003
1438 DynaSoapANTIBACTERIAL HAND SOAPDynarex Corporationab0d5f64-9168-2ea3-e053-2a95a90a321e2026-04-29WarningsExact identifier
application number: M003
SCOTT Antimicrobial Foam Skin CleanserBENZALKONIUM CHLORIDEKimberly-Clark210f7da3-63c5-4a4b-8db0-8d6d1663751d2026-04-28WarningsExact identifier
application number: M003
anzoon ANTISEPTIC WIPESBENZETHONIUM CHLORIDE/BENZALKONIUM CHLORIDEShandong ACZ Biotechnology Co., Ltd.506cd089-f9a7-d9e5-e063-6394a90af6962026-04-27WarningsExact identifier
application number: M003

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
78280-401-057828004010517 mL in 1 BOTTLE, SPRAY (78280-401-05) 17 ml2025-08-01NoNoCurrent
78280-401-107828004011028 mL in 1 BOTTLE, SPRAY (78280-401-10) 28 ml2023-10-11NoNoCurrent