FDA.reportPublic FDA data

MK BZK Swab Non-Sterile

Product NDC
59050-434
Requested package NDC
59050-434-20
11-digit product format
590500434
Labeler code
59050
Product ID
59050-434_cea59e0d-83bd-9409-e053-2a95a90ac93c
Type
HUMAN OTC DRUG
Nonproprietary name
BENZALKONIUM CHLORIDE
Dosage form
LIQUID
Route
TOPICAL
Labeler
Changzhou Maokang Medical Products Co., Ltd
Application
part333E
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2014-04-11
Marketing end
0000-00-00
Substance
BENZALKONIUM CHLORIDE
Active strength
1 mg/mL
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage59050-43459050-434-20DDiscontinued by firm2026-10-12

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 · 10 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
59050-434-202023-02-03C16284748780-1f386c649-f5df-0266-e053-dadaa90a7c1aMK BZK Swab Non-Sterile
59050-434-202023-01-30C16284748780-1f386c649-f5df-0266-e053-dadaa90a7c1aMK BZK Swab Non-Sterile
59050-434-212020-01-31C16284748780-19d75b9d1-2568-f424-e053-dadaa90a57ceMK BZK Swab Sterile

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59050-434-21MK BZK Swab Sterile200 in 1 BOXLIQUID2001
59050-434-21MK BZK Swab Sterile0.4 mL in 1 POUCHLIQUID0.41

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BENZALKONIUM CHLORIDEACTIVE INGREDIENTF5UM2KM3W7MK BZK SWAB STERILE (BENZALKONIUM CHLORIDE) LIQUID [CHANGZHOU MAOKANG MEDICAL PRODUCTS CO., LTD]1
BENZALKONIUM CHLORIDEACTIVE INGREDIENTF5UM2KM3W7MK BZK SWAB NON-STERILE (BENZALKONIUM CHLORIDE) LIQUID [CHANGZHOU MAOKANG MEDICAL PRODUCTS CO., LTD]1
BENZALKONIUMACTIVE MOIETY7N6JUD5X6YMK BZK SWAB STERILE (BENZALKONIUM CHLORIDE) LIQUID [CHANGZHOU MAOKANG MEDICAL PRODUCTS CO., LTD]1
BENZALKONIUMACTIVE MOIETY7N6JUD5X6YMK BZK SWAB NON-STERILE (BENZALKONIUM CHLORIDE) LIQUID [CHANGZHOU MAOKANG MEDICAL PRODUCTS CO., LTD]1
WATERINACTIVE INGREDIENT059QF0KO0RMK BZK SWAB STERILE (BENZALKONIUM CHLORIDE) LIQUID [CHANGZHOU MAOKANG MEDICAL PRODUCTS CO., LTD]1
WATERINACTIVE INGREDIENT059QF0KO0RMK BZK SWAB NON-STERILE (BENZALKONIUM CHLORIDE) LIQUID [CHANGZHOU MAOKANG MEDICAL PRODUCTS CO., LTD]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59050-434MK BZK SWAB STERILE (BENZALKONIUM CHLORIDE) LIQUID [CHANGZHOU MAOKANG MEDICAL PRODUCTS CO., LTD]1Legacy NDC, 2 package rows20140312_d331f064-ef6e-44c5-8ce5-be7b1b39a658.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1038558benzalkonium chloride 0.13 % Medicated PadPSNd331f064-ef6e-44c5-8ce5-be7b1b39a6581
1038558benzalkonium chloride 1.3 MG/ML Medicated PadSCDd331f064-ef6e-44c5-8ce5-be7b1b39a6581
1038558benzalkonium chloride 0.13 % Topical ClothSYd331f064-ef6e-44c5-8ce5-be7b1b39a6581
1038558benzalkonium chloride 0.13 % Topical SwabSYd331f064-ef6e-44c5-8ce5-be7b1b39a6581
1038558benzalkonium chloride 0.13 GM per 100 GM Topical PadSYd331f064-ef6e-44c5-8ce5-be7b1b39a6581
1038558benzalkonium chloride 0.13 GM per 100 GM Topical SwabSYd331f064-ef6e-44c5-8ce5-be7b1b39a6581
1038558benzalkonium chloride 1 ML per 750 ML Topical SwabSYd331f064-ef6e-44c5-8ce5-be7b1b39a6581

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59050-434-2059050043420200 POUCH in 1 BOX (59050-434-20) > .4 mL in 1 POUCH200 pouch2014-04-110000-00-00NoNoCurrent