FDA.reportPublic FDA data

Antiseptic Cleaning wipe

Product NDC
84449-004
11-digit product format
844490004
Labeler code
84449
Product ID
84449-004_479e3bf2-2348-8bdd-e063-6294a90ae3ea
Type
HUMAN OTC DRUG
Nonproprietary name
Antiseptic Cleaning wipe
Dosage form
PATCH
Route
TOPICAL
Labeler
SHENZHEN BENLIJU BIO-TECH CO.,LTD
Application
M003
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-08-22
Substance
BENZALKONIUM CHLORIDE; CHLORHEXIDINE
Active strength
4; 10 mg/g; mg/g
Pharmacologic classes
Decreased Cell Wall Integrity [PE]
NDC exclude flag
No
Listing certified through
2027-12-31
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
Antiseptic Cleaning wipe
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BENZALKONIUM CHLORIDE4 mg/g
CHLORHEXIDINE10 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
F5UM2KM3W7Internal UNII lookup
R4KO0DY52LInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
203d01ae-d99e-bce3-e063-6294a90a1a2dAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
bb6d6c68-649d-4e6d-a1f6-603d969c8f68Product name120160303

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84449-004-01Antiseptic Cleaning wipe1 g in 1 PATCHPATCH13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84449-004ANTISEPTIC CLEANING WIPE PATCH [SHENZHEN BENLIJU BIO-TECH CO.,LTD]2Current NDC, 1 package rows20250115_203d01ae-d99e-bce3-e063-6294a90a1a2d.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 38 of 115 · 2,286 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Isopropyl AlcoholISOPROPYL ALCOHOLBig Lots Stores, Inc.2c941c08-929c-43c9-966b-279086afca962026-01-29Warnings, Adverse reactionsExact identifier
application number: M003
70%ISOPROPYL ALCOHOLBig Lots Stores, Inc.2ef87a8a-58be-4123-ad03-9891e6916f1a2026-01-29Warnings, Adverse reactionsExact identifier
application number: M003
Hydrogen PeroxideHYDROGEN PEROXIDECardinal Health, 110 dba Leaderd1418649-9490-4dab-b89c-9de6bb7196422026-01-29WarningsExact identifier
application number: M003
Ethyl Rubbing AlcoholETHYL ALCOHOLCardinal Health, 110 dba Leaderc56cbcbf-8e0e-4dff-80d3-df420c500a932026-01-29Warnings, Adverse reactionsExact identifier
application number: M003
Isopropyl AlcoholISOPROPYL ALCOHOLCariba International001c1fcf-2808-467c-86d8-c038513fa3b52026-01-29WarningsExact identifier
application number: M003
70%ISOPROPYL ALCOHOLCariba International483586f4-aab4-40c2-8925-c4f7fb22c6aa2026-01-29Warnings, Adverse reactionsExact identifier
application number: M003
Hydrogen PeroxideHYDROGEN PEROXIDECariba International2c48f58a-a2d1-4a28-8dbf-a9d2c620bca62026-01-29Warnings, Adverse reactionsExact identifier
application number: M003
New Skin BandageBENZETHONIUM CHLORIDEAdvantice Health, LLC60996119-8367-4e22-b6ec-c36490635fa42026-01-28WarningsExact identifier
application number: M003
BZK PadsBENZALKONIUM CHLORIDEDynarex Corporation1409c437-ff17-481d-94be-87dd6d463ba92026-01-28WarningsExact identifier
application number: M003
Singular Wipes UnscentedISOPROPYL ALCOHOLSINGULAR ENTERPRISES LLCac2b352f-6cb2-4683-bb41-13e8ecb186bf2026-01-27WarningsExact identifier
application number: M003
Singular Wipes fresh Citrus ScentALCOHOLSINGULAR ENTERPRISES LLC867a25d2-3d2c-4dad-bbe8-84195c03a87d2026-01-27WarningsExact identifier
application number: M003
Antibacterial Hand WipeANTIBACTERIAL HAND WIPEFujian Yifa Healthcare Products Co., Ltd.4906f079-8c9f-e3b0-e063-6294a90ad0f82026-01-26WarningsExact identifier
application number: M003
Antibacterial Hand WipeANTIBACTERIAL HAND WIPEFujian Yifa Healthcare Products Co., Ltd.4912b681-e21a-1ddf-e063-6294a90aa9f42026-01-26WarningsExact identifier
application number: M003
Antibacterial Hand WipeANTIBACTERIAL HAND WIPEFujian Yifa Healthcare Products Co., Ltd.491a6d77-8a84-c76d-e063-6394a90ac61f2026-01-26WarningsExact identifier
application number: M003
Antibacterial Hand WipeANTIBACTERIAL HAND WIPEFujian Yifa Healthcare Products Co., Ltd.491b55ca-2c7a-0eb7-e063-6394a90a9cb72026-01-26WarningsExact identifier
application number: M003
Antibacterial Hand WipeANTIBACTERIAL HAND WIPEFujian Yifa Healthcare Products Co., Ltd.491c4af8-c699-7128-e063-6294a90ae0f92026-01-26WarningsExact identifier
application number: M003
Antibacterial Hand WipeANTIBACTERIAL HAND WIPEFujian Yifa Healthcare Products Co., Ltd.491de8ca-07e7-0aa3-e063-6394a90ae36f2026-01-26WarningsExact identifier
application number: M003
Antibacterial Hand WipeANTIBACTERIAL HAND WIPEFujian Yifa Healthcare Products Co., Ltd.492793db-7dc2-8313-e063-6394a90a52bf2026-01-26WarningsExact identifier
application number: M003
Antibacterial Hand WipeANTIBACTERIAL HAND WIPEFujian Yifa Healthcare Products Co., Ltd.4928615e-d1a9-72b8-e063-6394a90aa7ed2026-01-26WarningsExact identifier
application number: M003
Antibacterial Hand WipeANTIBACTERIAL HAND WIPEFujian Yifa Healthcare Products Co., Ltd.4943e51a-bb8e-745a-e063-6294a90a0a3d2026-01-26WarningsExact identifier
application number: M003

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
84449-004-01844490004011 g in 1 PATCH (84449-004-01) 1 g2024-08-22NoNoCurrent