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 27 of 114 · 2,277 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Povidone Iodine Prep PadANTISEPTICDynarex Corporation81b475e8-8da4-7b15-e053-2991aa0a66292026-03-25WarningsExact identifier
application number: M003
Antibacterial Hand WipeANTIBACTERIAL HAND WIPEFujian Yifa Healthcare Products Co., Ltd.4dde3373-1c75-a815-e063-6294a90aa5572026-03-25WarningsExact identifier
application number: M003
Los Poblanos Lavender Hand SanitizerALCOHOLSombra Cosmetics Inc.4ddef71b-f5b8-57f5-e063-6294a90a78a32026-03-25WarningsExact identifier
application number: M003
palm partyALCOHOL HAND SANITIZERDongyang Loulee Cosmetics Co.,Ltd.48786094-aa70-d0ca-e063-6394a90acd882026-03-25WarningsExact identifier
application number: M003
palm partyALCOHOL GELDongyang Loulee Cosmetics Co.,Ltd.487c4724-b618-a071-e063-6394a90aa7822026-03-25WarningsExact identifier
application number: M003
AshleyBelle Moisturizing Hand Sanitizer Bellini GlowETHYL ALCOHOLMY IMPORTS USA LLC4dbe636b-f376-7e30-e063-6394a90a722b2026-03-24WarningsExact identifier
application number: M003
AshleyBelle Moisturizing Hand Sanitizer Coconut LimeETHYL ALCOHOLMY IMPORTS USA LLC4dbe7020-e302-8706-e063-6394a90abe7c2026-03-24WarningsExact identifier
application number: M003
AshleyBelle Moisturizing Hand Sanitizer Island VanillaETHYL ALCOHOLMY IMPORTS USA LLC4dbe79d2-ee73-a8ed-e063-6394a90a7db52026-03-24WarningsExact identifier
application number: M003
AshleyBelle Moisturizing Hand Sanitizer Pink SugarETHYL ALCOHOLMY IMPORTS USA LLC4dbe8d3f-afac-cc82-e063-6294a90ae3092026-03-24WarningsExact identifier
application number: M003
AshleyBelle Moisturizing Hand Sanitizer Raspberry LemonadeETHYL ALCOHOLMY IMPORTS USA LLC4dcfcd41-b93f-accf-e063-6394a90a963d2026-03-24WarningsExact identifier
application number: M003
AshleyBelle Moisturizing Hand Sanitizer Sunlit Lemon CreamETHYL ALCOHOLMY IMPORTS USA LLC4dd00a64-c0bf-cf7d-e063-6394a90a76922026-03-24WarningsExact identifier
application number: M003
AshleyBelle Moisturizing Hand Sanitizer Sweet Mint SplashETHYL ALCOHOLMY IMPORTS USA LLC4dd010e2-7bcf-666f-e063-6294a90a4f3c2026-03-24WarningsExact identifier
application number: M003
AshleyBelle Moisturizing Hand Sanitizer Vanilla SwirlETHYL ALCOHOLMY IMPORTS USA LLC4dd01f13-5ea3-7744-e063-6294a90a124f2026-03-24WarningsExact identifier
application number: M003
AshleyBelle Moisturizing Hand Sanitizer Raspberry LemonadeETHYL ALCOHOLZhejiang Guoyao Jingyue Aerosol Co., Ltd.4daa1aed-d763-2098-e063-6394a90a704b2026-03-23WarningsExact identifier
application number: M003
AshleyBelle Moisturizing Hand Sanitizer Sunlit Lemon CreamETHYL ALCOHOLZhejiang Guoyao Jingyue Aerosol Co., Ltd.4daa4b88-0ea3-2143-e063-6294a90a69ce2026-03-23WarningsExact identifier
application number: M003
povidine iodinePOVIDINE IODINEDynarex Corporation564ec54b-353e-45a8-85e8-a39f89488d9c2026-03-23WarningsExact identifier
application number: M003
DURMA DynaWound CleanserWOUND CLEANSERDynarex Corporation6a4dd82a-6b06-426b-9afd-415a1a4339b42026-03-23WarningsExact identifier
application number: M003
AshleyBelle Moisturizing Hand Sanitizer Sweet Mint SplashETHYL ALCOHOLZhejiang Guoyao Jingyue Aerosol Co., Ltd.4dbc68be-558b-03f0-e063-6394a90aa90d2026-03-23WarningsExact identifier
application number: M003
AshleyBelle Moisturizing Hand Sanitizer Vanilla SwirlETHYL ALCOHOLZhejiang Guoyao Jingyue Aerosol Co., Ltd.4dbc8688-f34b-1178-e063-6394a90a0e672026-03-23WarningsExact identifier
application number: M003
AshleyBelle Moisturizing Hand Sanitizer Coconut LimeETHYL ALCOHOLZhejiang Guoyao Jingyue Aerosol Co., Ltd.4da93596-ec59-1e56-e063-6394a90afceb2026-03-22WarningsExact 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