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 104 of 114 · 2,275 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Safly BZK Antiseptic ToweletteBENZALKONIUM CHLORIDEJIANGMEN SHUIZIRUN SANITARY ARTICLES CO., LTD.5cd9043e-daf2-43eb-9568-54775fc4f84a2024-05-15WarningsExact identifier
application number: M003
Noshinku Bergamot Hand SanitizerALCOHOLNoshinku53fea81e-4482-6fae-e054-00144ff8d46c2024-05-14WarningsExact identifier
application number: M003
Noshinku Eucalyptus Hand SanitizerALCOHOLNoshinku9dcb8b51-d1bb-4305-a5ff-8cc8bdcdc4c02024-05-14WarningsExact identifier
application number: M003
Noshinku Lavender Hand SanitizerALCOHOLNoshinkua57e44b2-f5fa-4c3c-a59c-aa73bfbb66cf2024-05-14WarningsExact identifier
application number: M003
LEADER 2% Mild Iodine TinctureIODINE AND SODIUM IODIDE AND ALCOHOL LIQUIDCardinal Health, 110 dba Leader7f810b92-60f6-2f72-e053-2991aa0ab9732024-05-13WarningsExact identifier
application number: M003
Leader Decolorized IodineALCOHOL LIQUIDCardinal Health, 110 dba Leader822f6f28-956f-dd82-e053-2991aa0ae7522024-05-13WarningsExact identifier
application number: M003
Inverness Ear CareBENZALKONIUM CHLORIDEThe Richline Group, Inc.180a2995-334c-2e93-e063-6294a90aecf72024-05-09WarningsExact identifier
application number: M003
Helzberg Diamonds Ear CareBENZALKONIUM CHLORIDEThe Richline Group, Inc.180a3776-0edd-26f3-e063-6294a90a740d2024-05-09WarningsExact identifier
application number: M003
Ulta Beauty Ear CareBENZALKONIUM CHLORIDEThe Richline Group, Inc.180a37f4-8718-3e40-e063-6294a90acaad2024-05-09WarningsExact identifier
application number: M003
Guardian VaginalBENZALKONIUM CHLORIDEEastern Century Pharmaceuticals1605ba44-02b7-4c72-9fec-89a5aa962b442024-04-24WarningsExact identifier
application number: M003
Inverness Hygienic Ear Care AntisepticBENZALKONIUM CHLORIDEThe Richline Group, Inc.0ccd72e7-16a2-47c7-9ce6-dffb63a0344b2024-04-18WarningsExact identifier
application number: M003
Lovisa Piercing Care SolutionBENZALKONIUM CHLORIDEThe Richline Group, Inc.74f46b81-cc5b-4e3f-a36e-0bd86d370c222024-04-18WarningsExact identifier
application number: M003
CliniClean BZK Cleansing Contains Benzalkonium ChlorideBENZALKONIUM CHLORIDEHR HealthCareb6916466-0931-408f-a430-0797a449c32e2024-04-18WarningsExact identifier
application number: M003
Handy Solutions First Aid KitBENZALKONIUM CHLORIDENavajo Manufacturing Company Inc.130237ff-3db4-1288-e063-6394a90ab1af2024-04-16WarningsExact identifier
application number: M003
BZKBENZALKONIUM CHLORIDEHenry Schein Inc.ff877b63-fa58-4770-a882-694eda33203b2024-04-02WarningsExact identifier
application number: M003
First Aid Antiseptic Pain Relieving Benzalkonium Chloride Lidocaine HydrochlorideBENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDEM-star (Hubei) Health&Care Products Co., Ltd.8e1f35ff-d4e6-4940-ad8f-dce2b73e595d2024-04-01WarningsExact identifier
application number: M003
Antiseptic Towelette TOALLITAS ANTISEPTICASBENZALKONIUM CHLORIDEM-star (Hubei) Health&Care Products Co., Ltd.b267e186-cf7a-458f-9c28-a48a8554af402024-04-01WarningsExact identifier
application number: M003
Antiseptic Povidone Iodine Prep PadPOVIDONE-IODINEM-star (Hubei) Health&Care Products Co., Ltd.fc76c1f3-b48e-4276-890d-5b8e5a894e622024-04-01WarningsExact identifier
application number: M003
Novex Hand SanitizerBENZALKONIUM CHLORIDENatural Essentials, Inc.8b53dde5-c9f6-41c4-8ddb-bf0bf67008d32024-03-20WarningsExact identifier
application number: M003
AntisepticBENZALKONIUM CHLORIDE 0.13%Trifecta Pharmaceuticals USA, LLC.13f1c70f-3b44-8eef-e063-6294a90af6342024-03-18WarningsExact 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