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 33 of 115 · 2,286 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
70%ISOPROPYL ALCOHOLValu Merchandisers Companybe57aa83-f097-4ff8-81f8-13d731eea4e62026-02-16Warnings, Adverse reactionsExact identifier
application number: M003
Isopropyl AlcoholISOPROPYL ALCOHOLValu Merchandisers Company81b5a92a-27a9-41d2-bc88-920833be66382026-02-16Warnings, Adverse reactionsExact identifier
application number: M003
Hydrogen PeroxideHYDROGEN PEROXIDEValu Merchandisers Company8235b54f-2468-45ca-bff0-9149e582e8862026-02-16Warnings, Adverse reactionsExact identifier
application number: M003
Dealmed BZK Antiseptic TowelettesBENZALKONIUM CHLORIDEDealmed Medical Supplies, LLC.90a16a08-a7bf-418d-a95e-d735fb179a702026-02-16WarningsExact identifier
application number: M003
IodineIODINEUnited Natural Foods, Inc. dba UNFI8e840855-d210-4a99-b73f-6c69dcf2b6fb2026-02-16WarningsExact identifier
application number: M003
IODDO IODINEIODINEEVI LABS4af8552c-1f2b-84ad-e063-6394a90abb622026-02-16WarningsExact identifier
application number: M003
SaniiSwabETHYL ALCOHOL 62%PolleyMed LLC3b06f3a4-de7f-0d16-e063-6394a90af0dc2026-02-14WarningsExact identifier
application number: M003
First Aid AntisepticPOVIDONE-IODINETopco Associates LLCe258fbd2-f1dd-4ba0-ac9b-64246f2db50b2026-02-13Warnings, Adverse reactionsExact identifier
application number: M003
Iodine TinctureIODINE TINCTURETopco Associates LLCe648f206-cc4f-4f5f-b31c-2fb8bf2708a72026-02-13Warnings, Adverse reactionsExact identifier
application number: M003
Hydrogen PeroxideHYDROGEN PEROXIDETopco Associates LLCc3509fd3-e1bc-42bd-881e-7fb520ace9f92026-02-13WarningsExact identifier
application number: M003
First Aid AntisepticPOVIDONE-IODINEWalgreen Co.b1c71ff1-8ffa-46df-9b43-86ed062c3a982026-02-12Warnings, Adverse reactionsExact identifier
application number: M003
IodineIODINEWalgreen Co.d3d44c9f-4eb6-4e5b-9943-c0f80f06952d2026-02-12Warnings, Adverse reactionsExact identifier
application number: M003
Hydrogen PeroxideHYDROGEN PEROXIDEWalgreen Co.eea239fe-554f-4487-9312-3ab0af27d5302026-02-12Warnings, Adverse reactionsExact identifier
application number: M003
Benzethonium chloride Plus Dyclonine hydrochlorideLIQUID BANDAGEChain Drug Consortium, LLCd7154398-4f52-434a-b51b-b7829ccebf3b2026-02-12WarningsExact identifier
application number: M003
Isopropyl alcoholISOPROPYL ALCOHOLMedline Industries, LP26e10080-d389-4994-e054-00144ff8d46c2026-02-11WarningsExact identifier
application number: M003
Isopropyl AlcoholISOPROPYL ALCOHOLMedline Industries, LPd980969d-694b-4c9e-a931-73beaceb51da2026-02-11WarningsExact identifier
application number: M003
Isopropyl alcoholISOPROPYL ALCOHOLMedline Industries, LP2c85e3c0-2876-31c3-e054-00144ff88e882026-02-11WarningsExact identifier
application number: M003
Isopropyl AlcoholISOPROPYL ALCOHOLMedline Industries, LP52a8b96e-dd4f-449e-b819-6f3ec5a27fb42026-02-11WarningsExact identifier
application number: M003
Hydrogen Peroxide First Aid AntisepticHYDROGEN PEROXIDEMedline Industries, LP4593f51a-9bcb-4149-9ce4-4f62183fd3dd2026-02-11WarningsExact identifier
application number: M003
Hydrogen peroxideHYDROGEN PEROXIDEMedline Industries, LP26a67a91-ee2d-6a6c-e054-00144ff88e882026-02-11WarningsExact 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