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 date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Archive	Snapshot	Source SHA-256
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product	34645-5008		E	Excluded after deficient or non-compliant submission was not corrected		excluded / ndc_excluded.zip	`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	34645-5008	34645-5008-3	E	Excluded after deficient or non-compliant submission was not corrected		excluded / ndc_excluded.zip	`110d247fa046…`	`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
Ingredient	Strength
BENZALKONIUM CHLORIDE	1.33 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
F5UM2KM3W7	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1043307	Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
d96c6ad2-c7e9-4079-9db2-59d108f284bb	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
34645-5008-3	BZK	1.4 mL in 1 POUCH	SWAB	1.4		8

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version	Uploaded
BENZALKONIUM CHLORIDE	ACTIVE INGREDIENT	F5UM2KM3W7	BZK (BENZALKONIUM CHLORIDE) SWAB [JIANGSU PROVINCE JIANERKANG MEDICAL DRESSING CO.,LTD]	2
BENZALKONIUM	ACTIVE MOIETY	7N6JUD5X6Y	BZK (BENZALKONIUM CHLORIDE) SWAB [JIANGSU PROVINCE JIANERKANG MEDICAL DRESSING CO.,LTD]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
34645-5008	BZK (BENZALKONIUM CHLORIDE) SWAB [JIANERKANG MEDICAL CO., LTD]	8	Current NDC, Legacy NDC, 1 package rows	20231023_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 32 of 114 · 2,277 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Travel Wipes Fresh Citrus Scent	ALCOHOL	SINGULAR ENTERPRISES LLC	ea77be5e-7c69-4787-b39a-4753b002dbbd	2026-02-18	Warnings	Exact identifier application number: M003
Travel Wipes Unscented	ISOPROPYL ALCOHOL	SINGULAR ENTERPRISES LLC	dd046146-fda7-438c-98ca-96ea1dd0ae0b	2026-02-18	Warnings	Exact identifier application number: M003
Benzalkonium chloride	FIRST AID ANTISEPTIC FOAM	Target Corporation	4599eb25-2877-fc62-e063-6294a90a5d18	2026-02-18	Warnings, Adverse reactions	Exact identifier application number: M003
Konix Povidone Iodine Topical Antiseptic	POVIDONE-IODINE	TURKUAZ SAGLIK HIZMETLERI MEDIKAL TEMIZLIK KIMYASAL URUNLER SANAYI VE TICARET AS	8a9848b0-19df-455a-9984-5ea2e5ce1b9f	2026-02-17	Warnings	Exact identifier application number: M003
Wintergreen 91 - Iron Lab	ETHYL ALCOHOL	Iron Lab SA de CV	323a0717-0d61-c911-e063-6394a90a4854	2026-02-17	Warnings	Exact identifier application number: M003
Ethyl Rubbing Alcohol	ALCOHOL	Iron Lab SA de CV	323b2f5d-34b9-8f5b-e063-6394a90a59d5	2026-02-17	Warnings	Exact identifier application number: M003
50 Ethyl Rubbing Alcohol	ALCOHOL	Iron Lab SA de CV	323b7ff8-91ce-c7a4-e063-6394a90a69fc	2026-02-17	Warnings	Exact identifier application number: M003
70 Alcohol Hand Sanitizer	ALCOHOL	Iron Lab SA de CV	323c06d5-c984-39b8-e063-6294a90a0d3f	2026-02-17	Warnings	Exact identifier application number: M003
50 Wintergreen Alcohol	ALCOHOL	Iron Lab SA de CV	323baeb1-e3ee-ec70-e063-6294a90a30f0	2026-02-17	Warnings	Exact identifier application number: M003
70 Rubbing Ethyl Alcohol	ALCOHOL	Iron Lab SA de CV	323be8b4-4588-e2a6-e063-6394a90ab68b	2026-02-17	Warnings	Exact identifier application number: M003
Hydrogen Peroxide	HYDROGEN PEROXIDE	United Natural Foods, Inc. dba UNFI	8a44aa29-58d6-4971-b572-4579f03ed227	2026-02-17	Warnings, Adverse reactions	Exact identifier application number: M003
INSTACLEAN HAND SANITIZING	ALCOHOL	SHIELD LINE LLC	6d606fae-d95e-cffc-e053-2991aa0a988b	2026-02-17	Warnings	Exact identifier application number: M003
Burn Cream	BENZALKONIUM CHLORIDE, LIDOCAINE HCI	Trifecta Pharmaceuticals USA LLC	087ac43c-1076-d1e2-e063-6294a90a5859	2026-02-16	Warnings	Exact identifier application number: M003
Isopropyl Alcohol	ISOPROPYL ALCOHOL	Valu Merchandisers Company	a631c976-cb9b-4099-8630-2a10c14bd3bd	2026-02-16	Warnings, Adverse reactions	Exact identifier application number: M003
70%	ISOPROPYL ALCOHOL	Valu Merchandisers Company	be57aa83-f097-4ff8-81f8-13d731eea4e6	2026-02-16	Warnings, Adverse reactions	Exact identifier application number: M003
Isopropyl Alcohol	ISOPROPYL ALCOHOL	Valu Merchandisers Company	81b5a92a-27a9-41d2-bc88-920833be6638	2026-02-16	Warnings, Adverse reactions	Exact identifier application number: M003
Hydrogen Peroxide	HYDROGEN PEROXIDE	Valu Merchandisers Company	8235b54f-2468-45ca-bff0-9149e582e886	2026-02-16	Warnings, Adverse reactions	Exact identifier application number: M003
Dealmed BZK Antiseptic Towelettes	BENZALKONIUM CHLORIDE	Dealmed Medical Supplies, LLC.	90a16a08-a7bf-418d-a95e-d735fb179a70	2026-02-16	Warnings	Exact identifier application number: M003
Iodine	IODINE	United Natural Foods, Inc. dba UNFI	8e840855-d210-4a99-b73f-6c69dcf2b6fb	2026-02-16	Warnings	Exact identifier application number: M003
IODDO IODINE	IODINE	EVI LABS	4af8552c-1f2b-84ad-e063-6394a90abb62	2026-02-16	Warnings	Exact identifier application number: M003

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
F5UM2KM3W7	BENZALKONIUM CHLORIDE	8001-54-5	BENZALKONIUM CHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1043307	benzalkonium Cl 0.133 % Medicated Pad	PSN	d96c6ad2-c7e9-4079-9db2-59d108f284bb	8
1043307	benzalkonium chloride 1.33 MG/ML Medicated Pad	SCD	d96c6ad2-c7e9-4079-9db2-59d108f284bb	8
1043307	benzalkonium chloride 0.133 % Medicated Towelette	SY	d96c6ad2-c7e9-4079-9db2-59d108f284bb	8
1043307	benzalkonium chloride 0.133 % Topical Swab	SY	d96c6ad2-c7e9-4079-9db2-59d108f284bb	8

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
34645-5008-3	34645500803	1.4 mL in 1 POUCH (34645-5008-3)	1.4 ml	2006-01-01	0000-00-00	No	No	Current

BZK