FDA.reportPublic FDA data

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 36 of 114 · 2,277 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Smart Care Hand Sanitizer Sweet Pea GardenALCOHOLShenzhen Lantern Scicence Co.,Ltd.49e7ce12-78a6-f86c-e063-6394a90a79e62026-02-03WarningsExact identifier
application number: M003
Smart Care Hand Sanitizer Jasmine JewelALCOHOLShenzhen Lantern Scicence Co.,Ltd.49e891ac-fa83-f687-e063-6294a90a52552026-02-03WarningsExact identifier
application number: M003
Smart Care Hand Sanitizer RosebudALCOHOLShenzhen Lantern Scicence Co.,Ltd.49e8bca0-e872-2585-e063-6294a90a34b22026-02-03WarningsExact identifier
application number: M003
Isopropyl AlcoholISOPROPYL ALCOHOLCVS Pharmacy, Inc.5e3efd36-f11e-4e50-8936-fc54e67eebe52026-02-03Warnings, Adverse reactionsExact identifier
application number: M003
70%ISOPROPYL ALCOHOLCVS Pharmacy, Inc.fbd9086c-39b2-449c-a06d-b85ec7d2dc722026-02-03Warnings, Adverse reactionsExact identifier
application number: M003
Isopropyl AlcoholISOPROPYL ALCOHOLCVS Pharmacy, Inc.c5f7741b-1f11-4a34-8f11-de6975c9578d2026-02-03Warnings, Adverse reactionsExact identifier
application number: M003
Ethyl Rubbing AlcoholETHYL ALCOHOLCVS Pharmacy, Inc.b4238c3a-f6bc-4232-932e-bece539955662026-02-03Warnings, Adverse reactionsExact identifier
application number: M003
Latalia Alcohol Antiseptic 80% SanitizingALCOHOLINTERNATIONAL CONSUMER PRODUCTS (PVT) LTD2da50235-5d89-4774-9c92-bb22cee081f12026-02-03WarningsExact identifier
application number: M003
Latalia alcohol disinfectant wipesETHYL ALCOHOLINTERNATIONAL CONSUMER PRODUCTS (PVT.) LTD4ef3c800-1754-4d9c-81d6-5309db7b04cf2026-02-03WarningsExact identifier
application number: M003
Escudo Ultra-Protect OriginalBENZALKONIUM CHLORIDEIndelpa, Inc1cd4c38f-8156-bd74-e063-6394a90a9f562026-02-03WarningsExact identifier
application number: M003
Escudo Ultra-Protect Soft CareBENZALKONIUM CHLORIDEIndelpa, Inc.1cc4b68b-dceb-3fab-e063-6294a90ab1122026-02-03WarningsExact identifier
application number: M003
Smart Care Hand Sanitizer Morning DewALCOHOLShenzhen Lantern Scicence Co.,Ltd.49f60996-6a03-77e0-e063-6394a90a7a112026-02-03WarningsExact identifier
application number: M003
Smart Care Hand Sanitizer Wild Cherry BlossomALCOHOLShenzhen Lantern Scicence Co.,Ltd.49f64148-5c63-0107-e063-6294a90a0c452026-02-03WarningsExact identifier
application number: M003
Smart Care Hand Sanitizer Citrus SunsetALCOHOLShenzhen Lantern Scicence Co.,Ltd.49f67a60-a6d8-0aa4-e063-6394a90a98592026-02-03WarningsExact identifier
application number: M003
WIPES4HEALTHBENZALKONIUM CHLORIDEBubble Marketing LLC5d6dd15b-d087-4f25-bd2b-035ecacd5f972026-02-03WarningsExact identifier
application number: M003
Isopropyl alcoholISOPROPYL ALCOHOLConcordance Healthcare Solutions, LLC1c051d6a-61a8-4a75-aeb6-7c1258bda2b22026-02-02Warnings, Adverse reactionsExact identifier
application number: M003
Dealmed Sterile Alcohol Prep Pads LargeISOPROPYL ALCOHOLDealmed Medical Supplies, LLC.75908e89-abd9-4760-bd11-fb71133ae2c02026-02-02WarningsExact identifier
application number: M003
Dealmed Sterile Alcohol Prep Pads MediumISOPROPYL ALCOHOLDealmed Medical Supplies, LLC.0cdfc6b4-7d66-4333-b38d-c465d4864b5c2026-02-02WarningsExact identifier
application number: M003
MedlinePOVIDONE-IODINEMedline Industries, LP494d7e97-a3a8-2c7a-e063-6394a90a3ae12026-02-02WarningsExact identifier
application number: M003
AplicareISOPROPYL ALCOHOLAplicare Products, LLC4950e07f-36a5-b6f5-e063-6294a90a8f982026-02-02WarningsExact 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