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 102 of 114 · 2,275 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
antibacterial hand sanitizer gel 01ALCOHOLCosmuses Cosmetics (Ningbo) Co., Ltd.202e5c15-8749-0a76-e063-6294a90a27202024-08-21WarningsExact identifier
application number: M003
Be Smart Get Prepared Burn CreamBENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDE ANHYDROUSTotal Resources International, Inceacb5138-4af8-4550-b883-5603ad96ed7d2024-08-16WarningsExact identifier
application number: M003
First Aid Only Povidone-Iodine AntisepticPOVIDONE-IODINEAcme United Corporatione0052ac2-4f74-32a4-e053-2995a90a94c62024-08-13WarningsExact identifier
application number: M003
Keep Going Sting Relief PadBENZOCAINE AND ISOPROPYL ALCOHOLJIANGMEN SHUIZIRUN SANITARY ARTICLES CO., LTD.36c11178-b70f-4355-8823-c2b72598dae52024-08-08WarningsExact identifier
application number: M003
Keep Going Non Sting Cleaning WipeBENZALKONIUM CHLORIDEJIANGMEN SHUIZIRUN SANITARY ARTICLES CO., LTD.6b7400d5-d4b8-4b68-b048-c1917cdf3ce32024-08-08WarningsExact identifier
application number: M003
Keep Going Alcohol Prep PadISOPROPYL ALCOHOLJIANGMEN SHUIZIRUN SANITARY ARTICLES CO., LTD.f67dd10c-746f-4c21-92f1-741f86218a692024-08-08WarningsExact identifier
application number: M003
Sugar Cookie Sanitizer 01ALCOHOLShenzhen Lantern Scicence Co.,Ltd.1efc0e9e-b4eb-d2b0-e063-6394a90a77792024-08-06WarningsExact identifier
application number: M003
Lemon Lime Hand Sanitizer Spray. 01ALCOHOLShenzhen Lantern Scicence Co.,Ltd.1efe7236-d7bd-2a1c-e063-6294a90a736e2024-08-06WarningsExact identifier
application number: M003
Maokang Medical 10 Povidone IodinePOVIDONE-IODINEChangzhou Maokang Medical Products Co., Ltd644e92c3-3043-4a76-9845-7e0482cf9f622024-07-19WarningsExact identifier
application number: M003
Dermal Wound CleanserBENZETHONIUM CHLORIDESmith & Nephew Medical Ltd.18704cd5-1ecf-4e8c-9897-7e45394e68c82024-07-15WarningsExact identifier
application number: M003
Novex Anti-Bacterial Hand Sanitizer WipeBENZALKONIUM CHLORIDEJIANGMEN SHUIZIRUN SANITARY ARTICLES CO., LTD.7832a0be-a8ce-4b56-a9bb-a375b97df2872024-07-10WarningsExact identifier
application number: M003
Callington Anti-Bacterial Hand Sanitizer WipeBENZALKONIUM CHLORIDEJIANGMEN SHUIZIRUN SANITARY ARTICLES CO., LTD.00ca48ca-893d-4a3f-ad90-119522664e082024-07-10WarningsExact identifier
application number: M003
Assorted Licensed Hand Sanitizer Grape 01ALCOHOLShenzhen Lantern Scicence Co.,Ltd.1c9095ad-ce19-3666-e063-6394a90ae22d2024-07-09WarningsExact identifier
application number: M003
AMORAY 70% ETHYL ALCOHOL HAND SANITIZER FRESH CITRUSETHYL ALCOHOLMY IMPORTS USA LLC1ccb78ed-36f9-a7d2-e063-6394a90a64772024-07-09WarningsExact identifier
application number: M003
AMORAY 70% ETHYL ALCOHOL HAND SANITIZER LAVENDERETHYL ALCOHOLMY IMPORTS USA LLC1ccb9671-1970-39f9-e063-6294a90ac0792024-07-09WarningsExact identifier
application number: M003
AMORAY 70% ETHYL ALCOHOL HAND SANITIZER STRAWBERRYETHYL ALCOHOLMY IMPORTS USA LLC1ccbc68e-2b6b-768c-e063-6294a90a643b2024-07-09WarningsExact identifier
application number: M003
AMORAY 70% ETHYL ALCOHOL HAND SANITIZER ORIGINALETHYL ALCOHOLMY IMPORTS USA LLC1ccbbc55-3f7d-76d1-e063-6294a90a55902024-07-09WarningsExact identifier
application number: M003
AMORAY 70% ETHYL ALCOHOL HAND SANITIZER LAVENDERETHYL ALCOHOLZhejiang Guoyao Jingyue Aerosol Co., Ltd.1cb701f7-61c8-e5f4-e063-6294a90a0c3c2024-07-08WarningsExact identifier
application number: M003
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

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