BZK

Product NDC
34645-5008
11-digit product format
346455008
Labeler code
34645
Product ID
34645-5008_085c7bca-1ee1-9d63-e063-6294a90a6e18
Type
HUMAN OTC DRUG
Nonproprietary name
Benzalkonium Chloride
Dosage form
SWAB
Route
TOPICAL
Labeler
Jianerkang Medical Co., Ltd
Application
M003
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2006-01-01
Substance
BENZALKONIUM CHLORIDE
Active strength
1.33 mg/mL
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 2 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2019-12-08 06:16 UTC · source 2019-12-05excluded productproduct34645-5008EExcluded after deficient or non-compliant submission was not correctedexcluded / ndc_excluded.zip110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage34645-500834645-5008-3EExcluded after deficient or non-compliant submission was not correctedexcluded / ndc_excluded.zip110d247fa046…a55b01930146…

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
BZK
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BENZALKONIUM CHLORIDE1.33 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

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

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1043307Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
d96c6ad2-c7e9-4079-9db2-59d108f284bbAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
34645-5008-3BZK1.4 mL in 1 POUCHSWAB1.48

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BENZALKONIUM CHLORIDEACTIVE INGREDIENTF5UM2KM3W7BZK (BENZALKONIUM CHLORIDE) SWAB [JIANGSU PROVINCE JIANERKANG MEDICAL DRESSING CO.,LTD]2
BENZALKONIUMACTIVE MOIETY7N6JUD5X6YBZK (BENZALKONIUM CHLORIDE) SWAB [JIANGSU PROVINCE JIANERKANG MEDICAL DRESSING CO.,LTD]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
34645-5008BZK (BENZALKONIUM CHLORIDE) SWAB [JIANERKANG MEDICAL CO., LTD]8Current NDC, Legacy NDC, 1 package rows20231023_d96c6ad2-c7e9-4079-9db2-59d108f284bb.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 100 of 114 · 2,270 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Target Up and Up 2-in-1 Hand SanitizerBENZETHONIUM CHLORIDETARGET CORPORATIONe069c9e6-024d-5482-e053-2995a90a767d2024-10-14WarningsExact identifier
application number: M003
Meridian Wrapped antibacterial DeodorantBENZETHONIUM CHLORIDEBob Barker Company Inc.7c834c1d-7930-4909-a600-6de9698e2b172024-10-14WarningsExact identifier
application number: M003
Meridian Unwrapped antibacterial DeodorantBENZETHONIUM CHLORIDEBob Barker Company Inc.adc10d22-a913-4bfa-a3f7-d6d5778f07ca2024-10-14WarningsExact identifier
application number: M003
First Aid Antiseptic Pain RelievingBENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDEHubei Changjian Medical Products Co., Ltd.9cb3759a-35d9-4f6b-94ad-fafd4bc600bd2024-10-11WarningsExact identifier
application number: M003
Antiseptic ToweletteBENZALKONIUM CHLORIDEHubei Changjian Medical Products Co., Ltd.bf045881-9636-4000-a0ac-f6aab6b818322024-10-11WarningsExact identifier
application number: M003
Antiseptic Povidone-lodine Prep PadPOVIDONE-IODINEHubei Changjian Medical Products Co., Ltd.2cacf2e0-0192-4e0f-88a6-e3eee3af54712024-10-11WarningsExact identifier
application number: M003
AntisepticETHANOLMcKesson6637290d-6ae4-5a83-e053-2991aa0a81c62024-10-11WarningsExact identifier
application number: M003
AntibacterialBENZETHONIUM CHLORIDEMcKesson58892abf-e0b9-83d9-e053-2a91aa0ad0352024-10-11WarningsExact identifier
application number: M003
AntibacterialBENZETHONIUM CHLORIDEMcKesson588a89cd-9481-6163-e053-2991aa0a9e3d2024-10-11WarningsExact identifier
application number: M003
McKesson Obstetrical Antiseptic ToweletteBENZALKONIUM CHLORIDEMcKesson Medical-Surgical51a3dabe-25d3-47fd-b640-83e68f7e06de2024-10-11WarningsExact identifier
application number: M003
McKesson Benzalkonium Chloride ToweletteBENZALKONIUM CHLORIDEMcKesson Medical-Surgicalcea36a9e-aac3-4494-a713-1dc64272d99c2024-10-11WarningsExact identifier
application number: M003
Alcohol Disinfecting WipeALCOHOLMcKesson Medical-Surgical64a0063d-a5da-4a46-9dca-16e4dbdac85c2024-10-11WarningsExact identifier
application number: M003
Mckesson Hand Cleanse and Soothe with AloeCHLOROXYLENOLMckesson Medical-Surgical Inc.075cd889-948a-49dd-8927-e22f7a5bff992024-10-10WarningsExact identifier
application number: M003
Hand SanitizerHAND SANITIZER UNSCENTEDCASAD Company, Inc07a891a3-dcf7-438f-bbf7-a20b2aa7d7d72024-10-09WarningsExact identifier
application number: M003
Hand SanitizerHAND SANITIZER UNSCENTEDCASAD Company, Inc0933de73-94b1-448e-b39f-ecffabf952882024-10-09WarningsExact identifier
application number: M003
EVERSOFT FOAMING HAND ANTI-BACTERIALCHLOROXYLENOLDraco Hygienic Products Inc.e9d4767b-21f2-b68f-e053-2995a90a5aba2024-10-08WarningsExact identifier
application number: M003
FOAMING HAND ALCOHOL FOAMALCOHOLDraco Hygienic Products Inc.14860a19-e1e8-71fc-e063-6394a90a9df82024-10-08WarningsExact identifier
application number: M003
FOAMING HAND ANTIBACTERIALCHLOROXYLENOLDraco Hygienic Products Inc.15256355-29ef-9b24-e063-6294a90a907d2024-10-08WarningsExact identifier
application number: M003
Germ Attack Hand SanitizerALCOHOLNatural Essentials, Inc.4d156264-566d-4516-876c-b6f5823a97f52024-10-04WarningsExact identifier
application number: M003
Germ Attack Hand SanitizerALCOHOLNatural Essentials, Inc.9d3a4dfe-f31d-4def-bfc2-ece69d13f8e42024-10-04WarningsExact identifier
application number: M003

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1043307benzalkonium Cl 0.133 % Medicated PadPSNd96c6ad2-c7e9-4079-9db2-59d108f284bb8
1043307benzalkonium chloride 1.33 MG/ML Medicated PadSCDd96c6ad2-c7e9-4079-9db2-59d108f284bb8
1043307benzalkonium chloride 0.133 % Medicated ToweletteSYd96c6ad2-c7e9-4079-9db2-59d108f284bb8
1043307benzalkonium chloride 0.133 % Topical SwabSYd96c6ad2-c7e9-4079-9db2-59d108f284bb8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
34645-5008-3346455008031.4 mL in 1 POUCH (34645-5008-3) 1.4 ml2006-01-010000-00-00NoNoCurrent