FDA.reportPublic FDA data

BZK Antiseptic

Product NDC
61333-500
11-digit product format
613330500
Labeler code
61333
Product ID
61333-500_48efec8f-83e6-0744-e063-6394a90a0c29
Type
HUMAN OTC DRUG
Nonproprietary name
benzalkonium chloride
Dosage form
SWAB
Route
TOPICAL
Labeler
Lights Medical Manufacture Co., Ltd.
Application
M005
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-06-02
Substance
BENZALKONIUM CHLORIDE
Active strength
.13 mg/100mg
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 · 4 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage61333-500-01e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage61333-500-019bebd1f3094a…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 Antiseptic
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BENZALKONIUM CHLORIDE.13 mg/100mg

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
698ed472-9204-46e3-95a4-d59e204628acAvailable on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61333-500-012021-06-02C16284748780-19d75b9d0-9e4a-f424-e053-dadaa90a57ce61333-500 BZK Antiseptic Swab
61333-500-012020-01-31C16284748780-19d75b9d0-9e4a-f424-e053-dadaa90a57ce61333-500 BZK Antiseptic Swab

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61333-500-01BZK Antiseptic1 in 1 PACKAGESWAB19
61333-500-01BZK Antiseptic0.4 mg in 1 POUCHSWAB0.49

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
benzalkonium chlorideACTIVE INGREDIENTF5UM2KM3W7BZK ANTISEPTIC (BENZALKONIUM CHLORIDE) SWAB [LIGHTS MEDICAL MANUFACTURE CO., LTD.]2
BENZALKONIUMACTIVE MOIETY7N6JUD5X6YBZK ANTISEPTIC (BENZALKONIUM CHLORIDE) SWAB [LIGHTS MEDICAL MANUFACTURE CO., LTD.]2
WaterINACTIVE INGREDIENT059QF0KO0RBZK ANTISEPTIC (BENZALKONIUM CHLORIDE) SWAB [LIGHTS MEDICAL MANUFACTURE CO., LTD.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61333-500BZK ANTISEPTIC (BENZALKONIUM CHLORIDE) SWAB [LIGHTS MEDICAL MANUFACTURE CO., LTD.]8Current NDC, Legacy NDC, 2 package rows20241226_698ed472-9204-46e3-95a4-d59e204628ac.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 47 of 49 · 973 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
FIRST SHIELDBENZALKONIUM CHLORIDE, LIDOCAINE HCIEver Ready First Aidee198aa1-ad0d-9185-e053-2a95a90a65952024-01-15WarningsExact identifier
application number: M005
Ever Ready HAND SANITIZERETHYL ALCOHOLEver Ready First Aidec1af7ef-3c95-9c60-e053-2a95a90acf472024-01-15WarningsExact identifier
application number: M005
MY MEDIC SUPER SANITIZERETHYL ALCOHOLSled Distribution, LLCe7451738-75d5-5dc4-e053-2a95a90a7aee2024-01-15WarningsExact identifier
application number: M005
Medical SuperALCOHOLBeijing HKKY Medical Tech. Co., Ltd.ed2649c6-d971-4338-8745-cd0a40f7b0c22024-01-13WarningsExact identifier
application number: M005
ER Hand Sanitizer PacketsALCOHOLEVER READY FIRST AIDd0b6d09c-26e0-45c7-8d37-7d42143b2e312024-01-11WarningsExact identifier
application number: M005
clotrimazoleCLOTRIMAZOLEProficient Rx LPeeb241a3-93ee-4b74-8cbb-65713d15e7e02024-01-01WarningsExact identifier
application number: M005
ClotrimazoleCLOTRIMAZOLEProficient Rx LPba1dc4a4-073f-4f30-bb9c-9ed0437004312024-01-01WarningsExact identifier
application number: M005
RUGBY ANTIFUNGAL CLOTRIMAZOLECLOTRIMAZOLEProficient Rx LP7c64553b-589c-4e65-a6f0-b2847bbbe8a62024-01-01WarningsExact identifier
application number: M005
Dr. Scholls Instant Cool Athletes foot treatment with MentholTOLNAFTATEScholl's Wellness Companydad00745-e411-35b8-e053-2a95a90a10002023-12-21WarningsExact identifier
application number: M005
TINEACIDETOLNAFTATEBlaine Labs Inc.273eb424-5dc3-40c8-9ea7-2f732cbd11c92023-12-21WarningsExact identifier
application number: M005
TERPENICOL ANTIFUNGALUNDECYLENIC ACIDBlaine Labs Inc.a020334e-aac9-4ea5-a0ea-8e5b021fe2eb2023-12-21WarningsExact identifier
application number: M005
TERPENICOLUNDECYLENIC ACIDBlaine Labs Inc.efd99ed1-07d3-4862-ae47-883f7d1c91c62023-12-21WarningsExact identifier
application number: M005
sunmark antifungalTOLNAFTATEA-S Medication Solutions6f85fbb0-297c-4949-83f2-ed9a521721542023-12-16WarningsExact identifier
application number: M005
Miconazole NitrateMICONAZOLE NITRATEA-S Medication Solutions7a0ef38a-9584-4e67-ba86-c31f86da1ed02023-12-11WarningsExact identifier
application number: M005
Miconazole NitrateMICONAZOLE NITRATEA-S Medication Solutions7d284f6f-a970-49fe-b45a-d5c6c2688bc22023-12-11WarningsExact identifier
application number: M005
Hi VeticTOLNAFTATESato Pharmaceutical Co., Ltd.2096e241-3ed3-49cd-88c4-71db1fd2934a2023-12-06WarningsExact identifier
application number: M005
Undecylenic AcidUNDECYLENIC ACIDChemco Corporation7391b53f-5567-1f45-e053-2991aa0a4fce2023-12-05WarningsExact identifier
application number: M005
Hi VeticTOLNAFTATESato Pharmaceutical Co., Ltd.be92b480-56e8-4371-adbc-40fe74f6747c2023-12-01WarningsExact identifier
application number: M005
Antifungal CreamANTIFUNGALBluePoint Laboratoriesb4c4240f-f84c-ec5e-e053-2a95a90aa0822023-11-17WarningsExact identifier
application number: M005
Antifungal CreamANTIFUNGALBluePoint Laboratoriesb564f971-2a9b-a605-e053-2995a90aee692023-11-17WarningsExact identifier
application number: M005

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1038558benzalkonium chloride 0.13 % Medicated PadPSN698ed472-9204-46e3-95a4-d59e204628ac9
1038558benzalkonium chloride 1.3 MG/ML Medicated PadSCD698ed472-9204-46e3-95a4-d59e204628ac9
1038558benzalkonium chloride 0.13 % Topical ClothSY698ed472-9204-46e3-95a4-d59e204628ac9
1038558benzalkonium chloride 0.13 % Topical SwabSY698ed472-9204-46e3-95a4-d59e204628ac9
1038558benzalkonium chloride 0.13 GM per 100 GM Topical PadSY698ed472-9204-46e3-95a4-d59e204628ac9
1038558benzalkonium chloride 0.13 GM per 100 GM Topical SwabSY698ed472-9204-46e3-95a4-d59e204628ac9
1038558benzalkonium chloride 1 ML per 750 ML Topical SwabSY698ed472-9204-46e3-95a4-d59e204628ac9

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61333-500-01613330500011 POUCH in 1 PACKAGE (61333-500-01) / .4 mg in 1 POUCH1 pouch2021-06-020000-00-00NoNoCurrent