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 81 of 114 · 2,277 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
UnguentinePHENOL, ZINC OXIDEOakhurst Company327038a1-b825-1199-e063-6394a90a7f5f2025-04-10WarningsExact identifier
application number: M003
Northside Hospital Grey Amenity KitSODIUM MONOFLUOROPHOSPATEASP Global, LLCa3cc89df-be1b-4d9a-8ba3-8578853254222025-04-09WarningsExact identifier
application number: M003
Isopropyl alcohol 70 percentISOPROPYL ALCOHOLTOP CARE (Topco Associates LLC)afe23634-27a4-46cf-b428-8fa3a274712c2025-04-09WarningsExact identifier
application number: M003
Isopropyl Alcohol 91 percentISOPROPYL ALCOHOLTOP CARE (Topco Associates LLC)3c70ba1c-b12f-4a98-b993-1179ebe3e0702025-04-09WarningsExact identifier
application number: M003
Band Aid Antiseptic CleansingBENZALKONIUM CHLORIDEKenvue Brands LLCd3190050-d646-5957-e053-2995a90ad5212025-04-08WarningsExact identifier
application number: M003
mart Care Assorted Hand Sanitizer 0.94oz-Sweet Pea 01ALCOHOLShenzhen Lantern Scicence Co.,Ltd.322b90e8-be38-7237-e063-6394a90a488f2025-04-07WarningsExact identifier
application number: M003
Meijer Hydrating Hand Sanitizer 1oz - WatermelonALCOHOLShenzhen Lantern Scicence Co.,Ltd.322c0bdd-4dc5-52e7-e063-6294a90a13802025-04-07WarningsExact identifier
application number: M003
Meijer Hydrating Hand Sanitizer 1oz - BerryALCOHOLShenzhen Lantern Scicence Co.,Ltd.322c56b0-7eb6-c33a-e063-6394a90a15fb2025-04-07WarningsExact identifier
application number: M003
Meijer Hydrating Hand Sanitizer 1oz - VanillaALCOHOLShenzhen Lantern Scicence Co.,Ltd.322ce179-c528-0f62-e063-6394a90ac5602025-04-07WarningsExact identifier
application number: M003
MEDI-FIRST First Aid AntisepticHYDROGEN PEROXIDEUltra Distributors Incb6f7b346-3d6b-5953-e053-2995a90a878f2025-04-07WarningsExact identifier
application number: M003
MEDI-FIRST First Aid AntisepticISOPROPYL ALCOHOLUltra Distributors Incb6c88941-9982-3a37-e053-2995a90a8a5a2025-04-07WarningsExact identifier
application number: M003
Walgreens Max Strength Burn GelBENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDEWalgreens Co.25a1e89b-bafd-4770-e063-6294a90a14d22025-04-07WarningsExact identifier
application number: M003
Eye WashWATERCMC Group Inc.6158a1f5-a6bc-4a3e-9d1d-0a310d9dc5612025-04-02WarningsExact identifier
application number: M003
Standard ANSI First AidWATER, BENZALKONIUM CHLORIDE, ISOPROPYL ALCOHOL, BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, LIDOCAINE HYDROCHLORIDECMC Group, Inc.e1ef74bf-8895-4200-a411-f726dcdaa9452025-04-02WarningsExact identifier
application number: M003
Clear DefenseETHYL ALCOHOLMelaleuca, Inc.a2178a68-780e-e69b-e053-2a95a90ab7d62025-04-02WarningsExact identifier
application number: M003
Large ANSI First Aid KitWATER, BENZALKONIUM CHLORIDE, ISOPROPYL ALCOHOL, BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, LIDOCAINE HYDROCHLORIDECMC Group, Inc.fa8578c2-a0bc-4e2e-a4f9-d48debfff3782025-04-02WarningsExact identifier
application number: M003
ETHYL ALCOHOLALCOHOLASP Global LLC67a4b949-ce8a-4841-a965-fcc94165135c2025-04-02WarningsExact identifier
application number: M003
Sanitizing Hand MistETHYL ALCOHOLALO New York LLC31baefe1-2521-9ef3-e063-6294a90a450e2025-04-01WarningsExact identifier
application number: M003
DeconimoHAND SANITIZING WIPESIMAGINE AMAZON LLC311c670d-8f87-b746-e063-6294a90afd5e2025-04-01WarningsExact identifier
application number: M003
Meijer Antibacterial Foaming Hand Wash0.13% BENZALKONIUM CHLORIDE SOLUTIONMeijer, Inc.1eb6b603-ef96-dfda-e063-6294a90ae4682025-03-31WarningsExact 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