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 112 of 114 · 2,275 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BZK Cleansing Swabsticks 4 TripleBENZALKONIUM CHLORIDEChangzhou Maokang Medical Products Co., Ltd52c74f75-d7ef-481b-b580-fba402d03d752023-11-09WarningsExact identifier
application number: M003
MK Alcohol Swabstick SterileISOPROPYL ALCOHOLChangzhou Maokang Medical Products Co., Ltd48d198f0-d505-4e45-b7c9-dd70658fd5fa2023-11-09WarningsExact identifier
application number: M003
Maokang 3 Hydrogen PeroxideHYDROGEN PEROXIDEChangzhou Maokang Medical Products Co., Ltdb4b478b9-426d-4864-a64c-31de9bbf5dc32023-11-09WarningsExact identifier
application number: M003
MK Sting Relief PadsBENZOCAINE, ISOPROPYL ALCOHOLChangzhou Maokang Medical Products Co., Ltd1a60dd1b-0116-42a2-a501-4f74e326a2e92023-11-09WarningsExact identifier
application number: M003
terrasil First Aid Antiseptic Wound and Burn Care KitHEXYLRESORCINOLAidance Scientific, Inc, DBA Aidance Skincare & Topical Solutions5ddb84e9-cdf7-4034-acd2-625f8d6e46012023-11-08WarningsExact identifier
application number: M003
Inverness Ear PiercingBENZALKONIUM CHLORIDEThe Richline Group, Inc.bcec8099-939b-4cff-b388-f4046164f2d42023-11-08WarningsExact identifier
application number: M003
Hygienic Ear Care AntisepticBENZALKONIUM CHLORIDEThe Richline Group, Inc.98b70f22-cd53-e61b-e053-2995a90a730d2023-11-06WarningsExact identifier
application number: M003
ISOPROPYL ALCOHOLISOPROPYL ALCOHOLDegasa, S.A. de C.V.b4145aa4-d810-4c20-8493-311a7e222eb92023-11-05WarningsExact identifier
application number: M003
HYDROGEN PEROXIDEHYDROGEN PEROXIDEDEGASA SA DE CV26bae595-6e76-4946-b98f-1aba2e69250d2023-11-05WarningsExact identifier
application number: M003
Hand SanitizerETHYL ALCOHOLRaining Rose, Inc.416267f2-85c5-6633-e054-00144ff8d46c2023-11-03WarningsExact identifier
application number: M003
Alcohol Prep Pads70%ISOPROPYL ALCOHOLRaya Pharmaceuticals LLCda108e12-4327-db1c-e053-2a95a90a211b2023-10-27WarningsExact identifier
application number: M003
POVIDONE-IODINE PAD- povidone-iodine swabPOVIDONE IODINE 10% W/W (EQUIVALENT TO IODINE 1%)Raya Pharmaceuticals LLCdbcbd1be-5274-3de3-e053-2995a90abf1c2023-10-27WarningsExact identifier
application number: M003
Isopropyl AlcoholISOPROPYL ALCOHOLJianerkang Medical Co., Ltd4bfea435-f40d-4976-8450-a699f7640c652023-10-23WarningsExact identifier
application number: M003
Sting ReliefBENZOCAINE, ISOPROPYL ALCOHOLJianerkang Medical Co., Ltd3a32398a-3f7e-4da0-bb1d-b3f369914b2a2023-10-23WarningsExact identifier
application number: M003
Povidone Iodine Prep PadPOVIDONE-IODINEJianerkang Medical Co., Ltd47a504b8-b0c0-030a-e054-00144ff88e882023-10-23WarningsExact identifier
application number: M003
Povidone Iodine PrepPOVIDONE-IODINEJianerkang Medical Co., Ltd47a504b8-b0af-030a-e054-00144ff88e882023-10-23WarningsExact identifier
application number: M003
BZKBENZALKONIUM CHLORIDEJianerkang Medical Co., Ltdd96c6ad2-c7e9-4079-9db2-59d108f284bb2023-10-23WarningsExact identifier
application number: M003
Povidone Iodine PrepPOVIDONE-IODINEJianerkang Medical Co., Ltd47a5690c-08bf-5092-e054-00144ff8d46c2023-10-23WarningsExact identifier
application number: M003
Povidone Iodine PrepPOVIDONE-IODINEJianerkang Medical Co., Ltd47a5726f-d314-50d9-e054-00144ff8d46c2023-10-23WarningsExact identifier
application number: M003
Povidone Iodine ScrubPOVIDONE-IODINEJianerkang Medical Co., Ltd47a5690c-08ad-5092-e054-00144ff8d46c2023-10-23WarningsExact 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