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 103 of 114 · 2,277 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AMORAY 70% ETHYL ALCOHOL HAND SANITIZER ORIGINALETHYL ALCOHOLZhejiang Guoyao Jingyue Aerosol Co., Ltd.1cb77267-73ad-efd2-e063-6294a90a43f72024-07-08WarningsExact identifier
application number: M003
AMORAY 70% ETHYL ALCOHOL HAND SANITIZER STRAWBERRYETHYL ALCOHOLZhejiang Guoyao Jingyue Aerosol Co., Ltd.1cb7d6ca-ef7e-5225-e063-6294a90aa6922024-07-08WarningsExact identifier
application number: M003
Assorted Licensed Hand Sanitizer Sweet pea 01ALCOHOLShenzhen Lantern Scicence Co.,Ltd.1cc8a756-852f-6cf8-e063-6394a90a57e62024-07-08WarningsExact identifier
application number: M003
Assorted Licensed Hand Sanitizer Vanilla 01ALCOHOLShenzhen Lantern Scicence Co.,Ltd.1cc90b2f-450f-1deb-e063-6394a90a64802024-07-08WarningsExact identifier
application number: M003
AMORAY 70% ETHYL ALCOHOL HAND SANITIZER FRESH CITRUSETHYL ALCOHOLZhejiang Guoyao Jingyue Aerosol Co., Ltd.1cb4316d-c8c6-3fa2-e063-6394a90a23d22024-07-07WarningsExact identifier
application number: M003
Antibacterial Hand SanitizerALCOHOLCosmuses Cosmetics (Ningbo) Co., Ltdf531053d-82e4-7613-e053-2995a90a349f2024-07-02WarningsExact identifier
application number: M003
Antibacterial Hand SanitizerALCOHOLCosmuses Cosmetics (Ningbo) Co., Ltd1ae5c268-1834-4ac2-931e-bb7fd0088cd22024-07-02WarningsExact identifier
application number: M003
Quality ChoiceISOPROPYL ALCOHOLChain Drug Marketing Association Inc1262c5d7-63ef-f1c1-e063-6294a90a1f0f2024-07-02WarningsExact identifier
application number: M003
Genuine First Aid Antiseptic ToweletteBENZALKONIUM CHLORIDEGFA Production (Xiamen) Co., Ltd.dfff78d2-e23c-40b2-8a49-8f4140bb0df62024-06-25WarningsExact identifier
application number: M003
Walgreens 3 Hydrogen Peroxide WipesHYDROGEN PEROXIDEWalgreen Company03c497cc-c8b1-43b7-86ba-f9f9fc7432bf2024-06-18WarningsExact identifier
application number: M003
AntimicrobialBODY CLEANSERMcKesson8ff06cea-3427-5b40-e053-2995a90a06342024-06-17WarningsExact identifier
application number: M003
SwabsISOPROPYL ALCOHOLMcKesson4650c945-8e38-5ad9-e054-00144ff8d46c2024-06-07WarningsExact identifier
application number: M003
HAND SANITIZER COCONUT BREEZEALCOHOLSCENT THEORY PRODUCTS LLC1a5152b3-d674-f69a-e063-6394a90a6cac2024-06-07WarningsExact identifier
application number: M003
HAND SANITIZER REBEL CHERRYALCOHOLSCENT THEORY PRODUCTS LLC1a503858-4d2f-8e32-e063-6294a90ade972024-06-07WarningsExact identifier
application number: M003
Antiseptic WipeBENZALKONIUM CHLORIDEJianerkang Medical Co., Ltd1a3c5fc9-70cc-e857-e063-6294a90a34242024-06-06WarningsExact identifier
application number: M003
Hydrogen PeroxideHYDROGEN PEROXIDEWildman Business Group1f95b277-e40c-4a17-e063-6294a90a11272024-06-01WarningsExact identifier
application number: M003
Hand SanitizerALCOHOLJIANGMEN SHUIZIRUN SANITARY ARTICLES CO., LTD.dbfdecf0-a961-4cc5-bf87-ae30bbc302dd2024-05-31WarningsExact identifier
application number: M003
hand sanitizer 01ALCOHOLCosmuses Cosmetics (Ningbo) Co., Ltd.19a6c3c6-4b27-9011-e063-6394a90ae5122024-05-30WarningsExact identifier
application number: M003
antibacterial hand sanitizer gel 01ALCOHOLCosmuses Cosmetics (Ningbo) Co., Ltd.19a7b2fc-239c-b53c-e063-6394a90a09062024-05-30WarningsExact identifier
application number: M003
MyMedic HydrocortisoneHYDROCORTISONENantong Health & Beyond Hygienic Products Inc.197fc623-2fb9-184c-e063-6394a90a41042024-05-28WarningsExact 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