FDA.reportPublic FDA data

BZK

Product NDC
0404-6735
Requested package NDC
0404-6735-01
11-digit product format
004046735
Labeler code
0404
Product ID
0404-6735_1522e337-1394-24fa-e063-6394a90ae000
Type
HUMAN OTC DRUG
Nonproprietary name
benzalkonium chloride
Dosage form
LIQUID
Route
TOPICAL
Labeler
Henry Schein Inc.
Application
M003
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2013-01-07
Substance
BENZALKONIUM CHLORIDE
Active strength
.0013 g/g
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 · 6 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2022-08-30 03:57 UTC · source 2022-08-29fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-0886f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-278dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-109bebd1f3094a…5416666fcb17…

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 CHLORIDE.0013 g/g

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
ff877b63-fa58-4770-a882-694eda33203bAvailable on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0404-6735-012023-07-13C16284748780-19d75b9d0-67bd-f424-e053-dadaa90a57ceANTISEPTIC – Benzalkonium chloride liquid Henry Schein
0404-6735-012020-01-31C16284748780-19d75b9d0-67bd-f424-e053-dadaa90a57ceANTISEPTIC – Benzalkonium chloride liquid Henry Schein

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0404-6735-01BZK2.5 g in 1 PACKETLIQUID2.55
0404-6735-01BZK100 in 1 BOXLIQUID1005

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
benzalkonium chlorideACTIVE INGREDIENTF5UM2KM3W7BZK (BENZALKONIUM CHLORIDE) LIQUID [HENRY SCHEIN INC.]1
benzalkoniumACTIVE MOIETY7N6JUD5X6YBZK (BENZALKONIUM CHLORIDE) LIQUID [HENRY SCHEIN INC.]1
alcoholINACTIVE INGREDIENT3K9958V90MBZK (BENZALKONIUM CHLORIDE) LIQUID [HENRY SCHEIN INC.]1
waterINACTIVE INGREDIENT059QF0KO0RBZK (BENZALKONIUM CHLORIDE) LIQUID [HENRY SCHEIN INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0404-6735BZK (BENZALKONIUM CHLORIDE) LIQUID [HENRY SCHEIN INC.]5Current NDC, Legacy NDC, 2 package rows20240404_ff877b63-fa58-4770-a882-694eda33203b.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 59 of 114 · 2,277 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
American Red Cross AntisepticBENZALKONIUM CHLORIDE 0.13%(W/W)/BENZOCAINE 5.00%(W/W)Zhejiang Guoyao Jingyue Aerosol Co., Ltd.41bbf123-9ff9-5e8a-e063-6394a90af15f2025-10-22WarningsExact identifier
application number: M003
CA-REZZ NORISC ANTIBACTERIAL SKIN CAREBENZETHONIUM CHLORIDEFNC MEDICAL CORPORATIONf93c55f9-b3e1-45f6-8e0d-09e60f5b822f2025-10-22WarningsExact identifier
application number: M003
CA-REZZ - NORISC - INCONTINENT WASHBENZETHONIUM CHLORIDEFNC MEDICAL CORPORATIONed26fa74-5ae8-4294-b61d-682d6ad4b32a2025-10-22WarningsExact identifier
application number: M003
CA-REZZ - LONG TERM CARE - INCONTINENT CLEANSERBENZETHONIUM CHLORIDEFNC MEDICAL CORPORATIONd06b0489-86d3-4bf1-928f-fc524a71560e2025-10-22WarningsExact identifier
application number: M003
Northside Hospital Maternity Backpack-BASEALCOHOL AND SODIUM MONOFLUOROPHOSPHATEASP Global, LLc86458169-92eb-45a5-b3cc-6eccd8caa1e82025-10-22WarningsExact identifier
application number: M003
Northside Hospital Maternity Backpack BASESODIUM MONOFLUOROPHOSPATEALLIANCE FORMULATIONS5d0e768f-086c-4b8c-b618-6dde70f302f92025-10-22WarningsExact identifier
application number: M003
AshleyBelle Moisturizing Hand Sanitizer Sea BreezeETHYL ALCOHOL 70% V/VZhejiang Guoyao Jingyue Aerosol Co., Ltd.41a5db85-05b8-ecd6-e063-6394a90ac3872025-10-21WarningsExact identifier
application number: M003
AshleyBelle Moisturizing Hand Sanitizer StrawBerry ShortCakeETHYL ALCOHOL 70% V/VZhejiang Guoyao Jingyue Aerosol Co., Ltd.41a62d9f-4d46-f8ca-e063-6294a90ae1ed2025-10-21WarningsExact identifier
application number: M003
AshleyBelle Moisturizing Hand Sanitizer Vanilla CloudETHYL ALCOHOL 70% V/VZhejiang Guoyao Jingyue Aerosol Co., Ltd.41a69d10-f7bf-cf17-e063-6294a90a177d2025-10-21WarningsExact identifier
application number: M003
AshleyBelle Moisturizing Hand Sanitizer Watermelon AloeETHYL ALCOHOL 70% V/VZhejiang Guoyao Jingyue Aerosol Co., Ltd.41a7735f-03b7-4fdc-e063-6394a90a100b2025-10-21WarningsExact identifier
application number: M003
American Red Cross 70% Isopropyl AlcoholISOPROPYL ALCOHOL(70%CONC.)Zhejiang Guoyao Jingyue Aerosol Co., Ltd.41b6ee3f-55f4-0502-e063-6394a90aa3572025-10-21WarningsExact identifier
application number: M003
Smart Care Luxury Hand Sanitizer Tangy TerraneALCOHOLShenzhen Lantern Scicence Co.,Ltd.4192dbc6-5d9a-d42a-e063-6394a90aa2d82025-10-20WarningsExact identifier
application number: M003
Smart Care Luxury Hand Sanitizer Sweet and StillALCOHOLShenzhen Lantern Scicence Co.,Ltd.41934870-d87e-1c51-e063-6294a90abd2d2025-10-20WarningsExact identifier
application number: M003
Smart Care Luxury Hand Sanitizer Cashmere CharALCOHOLShenzhen Lantern Scicence Co.,Ltd.41938c11-391c-0a55-e063-6394a90ad4512025-10-20WarningsExact identifier
application number: M003
Smart Care Luxury Hand Sanitizer Tea and TimberALCOHOLShenzhen Lantern Scicence Co.,Ltd.4193d08a-bc54-ef3b-e063-6294a90a06082025-10-20WarningsExact identifier
application number: M003
AshleyBelle Moisturizing Hand Sanitizer Coastal CoconutETHYL ALCOHOL 70% V/VZhejiang Guoyao Jingyue Aerosol Co., Ltd.41940273-689d-0f44-e063-6294a90a957f2025-10-20WarningsExact identifier
application number: M003
Smart Care Luxury Hand Sanitizer Vanilla VerdantALCOHOLShenzhen Lantern Scicence Co.,Ltd.41942841-faa9-114e-e063-6294a90a0e582025-10-20WarningsExact identifier
application number: M003
Smart Care Luxury Hand Sanitizer Zen and ZestALCOHOLShenzhen Lantern Scicence Co.,Ltd.419441a8-a6df-e15d-e063-6294a90a02ae2025-10-20WarningsExact identifier
application number: M003
CVS Alcohol PrepISOPROPYL ALCOHOLCVS Pharmacy7abc66f2-faf6-421c-9c3c-b69f5a5872462025-10-20WarningsExact identifier
application number: M003
Gentian VioletGENTIAN VIOLETWorld Perfumes Inc419cc9a2-bfde-a516-e063-6294a90a065c2025-10-20WarningsExact identifier
application number: M003

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0404-6735-0100404673501100 PACKET in 1 BOX (0404-6735-01) / 2.5 g in 1 PACKET100 packet2016-12-01NoNoCurrent