FDA.reportPublic FDA data

MK BZK Antiseptic Towelette Non-Sterile

Product NDC
59050-331
Requested package NDC
59050-331-21
11-digit product format
590500331
Labeler code
59050
Product ID
59050-331_44e4fdde-d5dc-6963-e063-6394a90aebe6
Type
HUMAN OTC DRUG
Nonproprietary name
BENZALKONIUM CHLORIDE
Dosage form
LIQUID
Route
TOPICAL
Labeler
Changzhou Maokang Medical Products Co., Ltd
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2019-02-23
Substance
BENZALKONIUM CHLORIDE
Active strength
1.3 mg/mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

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 packagepackage59050-33159050-331-21DDiscontinued by firm2026-08-17

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 · 12 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…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…

Additional Listing Data#

Finished product
Yes
Brand name base
MK BZK Antiseptic Towelette Non-Sterile
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BENZALKONIUM CHLORIDE1.3 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
1038558Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
ffbf8815-b3d1-4c08-8475-16484ed4c8adAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59050-331-21MK BZK Antiseptic Towelette Non-Sterile1 in 1 POUCHLIQUID15
59050-331-21MK BZK Antiseptic Towelette Non-Sterile1 in 1 PACKAGELIQUID15

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BENZALKONIUM CHLORIDEACTIVE INGREDIENTF5UM2KM3W7MK BZK ANTISEPTIC TOWELETTE NON-STERILE (BENZALKONIUM CHLORIDE) LIQUID [CHANGZHOU MAOKANG MEDICAL PRODUCTS CO., LTD]1
BENZALKONIUMACTIVE MOIETY7N6JUD5X6YMK BZK ANTISEPTIC TOWELETTE NON-STERILE (BENZALKONIUM CHLORIDE) LIQUID [CHANGZHOU MAOKANG MEDICAL PRODUCTS CO., LTD]1
WATERINACTIVE INGREDIENT059QF0KO0RMK BZK ANTISEPTIC TOWELETTE 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
59050-331MK BZK ANTISEPTIC TOWELETTE NON-STERILE (BENZALKONIUM CHLORIDE) LIQUID [CHANGZHOU MAOKANG MEDICAL PRODUCTS CO., LTD]4Current NDC, Legacy NDC, 2 package rows20250101_ffbf8815-b3d1-4c08-8475-16484ed4c8ad.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 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MK BZK Antiseptic Towelette Non-SterileBENZALKONIUM CHLORIDEChangzhou Maokang Medical Products Co., Ltdffbf8815-b3d1-4c08-8475-16484ed4c8ad2025-12-01WarningsExact identifier
ndc (package): 59050-331-21
ndc (product): 59050-331
ndc11 (package): 59050033121

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1038558benzalkonium chloride 0.13 % Medicated PadPSNffbf8815-b3d1-4c08-8475-16484ed4c8ad5
1038558benzalkonium chloride 1.3 MG/ML Medicated PadSCDffbf8815-b3d1-4c08-8475-16484ed4c8ad5
1038558benzalkonium chloride 0.13 % Topical ClothSYffbf8815-b3d1-4c08-8475-16484ed4c8ad5
1038558benzalkonium chloride 0.13 % Topical SwabSYffbf8815-b3d1-4c08-8475-16484ed4c8ad5
1038558benzalkonium chloride 0.13 GM per 100 GM Topical PadSYffbf8815-b3d1-4c08-8475-16484ed4c8ad5
1038558benzalkonium chloride 0.13 GM per 100 GM Topical SwabSYffbf8815-b3d1-4c08-8475-16484ed4c8ad5
1038558benzalkonium chloride 1 ML per 750 ML Topical SwabSYffbf8815-b3d1-4c08-8475-16484ed4c8ad5
1038558benzalkonium chloride 0.13 % Medicated PadPSN130237ff-3db4-1288-e063-6394a90ab1af2
1043307benzalkonium Cl 0.133 % Medicated PadPSNc927f845-1383-ae85-e053-2995a90a12fc2
1038558benzalkonium chloride 1.3 MG/ML Medicated PadSCD130237ff-3db4-1288-e063-6394a90ab1af2
1043307benzalkonium chloride 1.33 MG/ML Medicated PadSCDc927f845-1383-ae85-e053-2995a90a12fc2
1038558benzalkonium chloride 0.13 % Topical ClothSY130237ff-3db4-1288-e063-6394a90ab1af2
1038558benzalkonium chloride 0.13 % Topical SwabSY130237ff-3db4-1288-e063-6394a90ab1af2
1038558benzalkonium chloride 0.13 GM per 100 GM Topical PadSY130237ff-3db4-1288-e063-6394a90ab1af2
1038558benzalkonium chloride 0.13 GM per 100 GM Topical SwabSY130237ff-3db4-1288-e063-6394a90ab1af2
1043307benzalkonium chloride 0.133 % Medicated ToweletteSYc927f845-1383-ae85-e053-2995a90a12fc2
1043307benzalkonium chloride 0.133 % Topical SwabSYc927f845-1383-ae85-e053-2995a90a12fc2
1038558benzalkonium chloride 1 ML per 750 ML Topical SwabSY130237ff-3db4-1288-e063-6394a90ab1af2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59050-331-21590500331211 POUCH in 1 PACKAGE (59050-331-21) / 1 POUCH in 1 POUCH / 1.6 mL in 1 POUCH1 pouch2019-02-230000-00-00NoNoCurrent