FDA.reportPublic FDA data

ANTIBACTERIAL BANDAGES

Product NDC
71584-0108
11-digit product format
715840108
Labeler code
71584
Product ID
71584-0108_418e777b-f366-ac92-e063-6394a90acf9f
Type
HUMAN OTC DRUG
Nonproprietary name
Benzalkonium Chloride
Dosage form
DRESSING
Route
TOPICAL
Labeler
Guangdong Comfort Medical Products Co., Ltd.
Application
M003
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2018-06-10
Substance
BENZALKONIUM CHLORIDE
Active strength
.12 g/100g
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
ANTIBACTERIAL BANDAGES
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BENZALKONIUM CHLORIDE.12 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
6e43b8b3-2d49-8f76-e053-2a91aa0affb0Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
71584-0108-12023-02-27ANTIBACTERIAL BANDAGES
71584-0108-12023-02-27ANTIBACTERIAL BANDAGES
71584-0108-22023-02-27ANTIBACTERIAL BANDAGES
71584-0108-22023-02-27ANTIBACTERIAL BANDAGES
71584-0108-32023-02-27ANTIBACTERIAL BANDAGES
71584-0108-32023-02-27ANTIBACTERIAL BANDAGES
71584-0108-42023-02-27ANTIBACTERIAL BANDAGES
71584-0108-42023-02-27ANTIBACTERIAL BANDAGES
71584-0108-52023-02-27ANTIBACTERIAL BANDAGES
71584-0108-52023-02-27ANTIBACTERIAL BANDAGES
71584-0108-62023-02-27ANTIBACTERIAL BANDAGES
71584-0108-62023-02-27ANTIBACTERIAL BANDAGES
71584-0108-12023-01-30ANTIBACTERIAL BANDAGES
71584-0108-12023-01-30ANTIBACTERIAL BANDAGES
71584-0108-22023-01-30ANTIBACTERIAL BANDAGES
71584-0108-22023-01-30ANTIBACTERIAL BANDAGES
71584-0108-32023-01-30ANTIBACTERIAL BANDAGES
71584-0108-32023-01-30ANTIBACTERIAL BANDAGES
71584-0108-42023-01-30ANTIBACTERIAL BANDAGES
71584-0108-42023-01-30ANTIBACTERIAL BANDAGES
71584-0108-52023-01-30ANTIBACTERIAL BANDAGES
71584-0108-52023-01-30ANTIBACTERIAL BANDAGES
71584-0108-62023-01-30ANTIBACTERIAL BANDAGES
71584-0108-62023-01-30ANTIBACTERIAL BANDAGES

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71584-0108-1ANTIBACTERIAL BANDAGES0.5 g in 1 POUCHDRESSING0.58
71584-0108-2ANTIBACTERIAL BANDAGES0.5 g in 1 POUCHDRESSING0.58
71584-0108-3ANTIBACTERIAL BANDAGES0.5 g in 1 POUCHDRESSING0.58
71584-0108-4ANTIBACTERIAL BANDAGES0.5 g in 1 POUCHDRESSING0.58
71584-0108-5ANTIBACTERIAL BANDAGES0.5 g in 1 POUCHDRESSING0.58
71584-0108-6ANTIBACTERIAL BANDAGES0.5 g in 1 POUCHDRESSING0.58

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71584-0108ANTIBACTERIAL BANDAGES (BENZALKONIUM CHLORIDE) DRESSING [GUANGDONG COMFORT MEDICAL PRODUCTS CO., LTD.]7Current NDC, Legacy NDC, 6 package rows20241013_6e43b8b3-2d49-8f76-e053-2a91aa0affb0.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 96 of 114 · 2,275 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DK12 Liquid Hand CreamyBENZALKONIUM CHLORIDE 0.13%Industria La Popular, S.A.01e2e51b-212b-368e-e063-6294a90a871c2024-12-02WarningsExact identifier
application number: M003
DK12 Fresh Energy Antibacterial and MoisturizingBENZALKONIUM CHLORIDE 0.1%Industria La Popular, S.A.fe80635d-9594-abf3-e053-6394a90aa78b2024-12-02WarningsExact identifier
application number: M003
DK12 Shower Gel CreamyBENZALKONIUM CHLORIDE 0.13%Industria La Popular, S.A.05e36111-ed4e-12de-e063-6294a90af6392024-12-02WarningsExact identifier
application number: M003
DK12 Creamy Antibacterial and MoisturizingBENZALKONIUM CHLORIDE 0.1%Industria La Popular, S.A.fe7fde7e-82fc-c13f-e053-6394a90aff682024-12-02WarningsExact identifier
application number: M003
DK12 Oatmeal Antibacterial and MoisturizingBENZALKONIUM CHLORIDE 0.1%Industria La Popular, S.A.fe16387b-1b16-1f41-e053-6294a90ae2c02024-12-02WarningsExact identifier
application number: M003
First Aid Antiseptic Isopropyl Alcohol PadISOPROPYL ALCOHOLFourstar Group USA, Inc.27edf5dc-3e68-bdd0-e063-6394a90ac4852024-11-27WarningsExact identifier
application number: M003
MicroKlenz AntimicrobialBENZETHONIUM CHLORIDEMedline Industries, LP115dda08-709c-490a-9693-419b514419602024-11-26WarningsExact identifier
application number: M003
First Aid Only Alcohol Antiseptic PadALCOHOL PADAcme United Corporation55421010-d806-4ca4-e054-00144ff88e882024-11-26WarningsExact identifier
application number: M003
First Aid Only Hydrogen Peroxide 3%HYDROGEN PEROXIDEAcme United Corporationnf1db8929-9b95-0d6e-e053-2995a90a817f2024-11-26WarningsExact identifier
application number: M003
First Aid Only Sting Relief PadBENZOCAINE, ISOPROPYL ALCOHOLAcme United Corporationd71047f6-1353-c758-e053-2995a90a962c2024-11-26WarningsExact identifier
application number: M003
First Aid Only Alcohol Antiseptic PadISOPROPYL ALCOHOLAcme United Coporationa01fec1b-1339-40b9-e053-2995a90aeda52024-11-23WarningsExact identifier
application number: M003
Med-Nap Sterile Alcohol Prep PadsISOPROPYL ALCOHOLAcme United Corporationc6eff57b-d537-69c8-e053-2a95a90adc3a2024-11-23WarningsExact identifier
application number: M003
First Aid Only Alcohol AntisepticISOPROPYL ALCOHOLAcme United Corporationa810e723-ad0c-8c71-e053-2995a90a0acc2024-11-23WarningsExact identifier
application number: M003
Universal 50% Rubbing AlcoholISOPROPYL ALCOHOLUniversal Distribution Center LLC0dcc9bd2-aea5-4c27-9956-47d56221726b2024-11-22WarningsExact identifier
application number: M003
Universal 70% Rubbing Alcohol with Wintergreen and GlycerinISOPROPYL ALCOHOLUniversal Distribution Center LLC9a9d42ad-79d5-4acc-b5d9-cb7468961d472024-11-22WarningsExact identifier
application number: M003
Universal 50% Rubbing Alcohol with Wintergreen and GlycerinISOPROPYL ALCOHOLUniversal Distribution Center LLC044a6287-f568-4cfa-a813-7fc0e6ffc3522024-11-22WarningsExact identifier
application number: M003
NEXXGEN 70% RUBBING ALCOHOLISOPROPYL ALCOHOLA & A Nexxgen LLCce73ac48-c5af-4a35-950c-62ff0232aa302024-11-22WarningsExact identifier
application number: M003
Universal 70% Rubbing AlcoholISOPROPYL ALCOHOLUniversal Distribution Center LLCd8b9b0e7-2cb8-4fc5-af55-790e64d6cfe82024-11-22WarningsExact identifier
application number: M003
Alcohol sterileISOPROPYL ALCOHOLCardinal Health, Incbb7c530f-5d80-4158-b715-09c1c837299d2024-11-21WarningsExact identifier
application number: M003
Alcohol sterileISOPROPYL ALCOHOLCardinal Health 200 LLC10135db9-f614-4511-96ac-faa6a02a1b612024-11-21WarningsExact identifier
application number: M003

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71584-0108-171584010801.5 g in 1 POUCH (71584-0108-1) 2018-06-100000-00-00NoNoCurrent
71584-0108-271584010802.5 g in 1 POUCH (71584-0108-2) 2021-10-050000-00-00NoNoCurrent
71584-0108-371584010803.5 g in 1 POUCH (71584-0108-3) 2021-10-050000-00-00NoNoCurrent
71584-0108-471584010804.5 g in 1 POUCH (71584-0108-4) 2021-10-050000-00-00NoNoCurrent
71584-0108-571584010805.5 g in 1 POUCH (71584-0108-5) 2021-10-050000-00-00NoNoCurrent
71584-0108-671584010806.5 g in 1 POUCH (71584-0108-6) 2021-10-050000-00-00NoNoCurrent