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 34 of 114 · 2,277 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
70%	ISOPROPYL ALCOHOL	Walgreen Co.	fb918e7a-1fe0-4cfd-8cf0-9d823eb56dcc	2026-02-10	Warnings, Adverse reactions	Exact identifier application number: M003
AMERICAN RED CROSS ANTISEPTIC CLEANSING FOAM	BENZALKONIUM CL 0.13% V/V	Zhejiang Guoyao Jingyue Aerosol Co., Ltd.	49e31509-d489-44be-e063-6394a90a97ef	2026-02-10	Warnings	Exact identifier application number: M003
AMERICAN RED CROSS ANTISEPTIC CLEANSING FOAM	BENZALKONIUM CL 0.13% V/V	MY IMPORTS USA LLC	4a849c4f-9b96-6b20-e063-6394a90a3486	2026-02-10	Warnings	Exact identifier application number: M003
Medline	ISOPROPYL ALCOHOL	Hy-Vee, Inc.	4bbce274-1e62-0c6a-e063-6394a90af92f	2026-02-10	Warnings	Exact identifier application number: M003
Everlit Care Products Antiseptic Wipe	ANTISEPTIC WIPE	EVERLIT GLOBAL INC.	3331e2f1-c3d0-41fc-a792-be5dcdf4e24a	2026-02-09	Warnings	Exact identifier application number: M003
EVERLIT CARE PRODUCTS PREP PAD	ISOPROPYL ALCOHOL	EVERLIT GLOBAL INC.	77a60360-8bb5-43e9-b7e4-f71d2d488c44	2026-02-09	Warnings	Exact identifier application number: M003
Everlit Care Products Sting Relief	ISOPROPYL ALCOHOL	EVERLIT GLOBAL INC.	adfab206-b7de-4f6a-a864-edd946ea743d	2026-02-09	Warnings	Exact identifier application number: M003
EVERLIT CARE PRODUCTS IODINE PREP PAD	POVIDONE-IODINE	EVERLIT GLOBAL INC.	5cbdb73d-333a-4244-a1c0-be430632f0ed	2026-02-09	Warnings	Exact identifier application number: M003
Alcohol	ISOPROPYL ALCOHOL	A-S Medication Solutions	6b8834be-0235-4f7c-8d52-c2f6aa2d3049	2026-02-08	Warnings	Exact identifier application number: M003
Hydrogen Peroxide	HYDROGEN PEROXIDE	Salado Sales Inc.	78a46975-568a-4a88-8597-9603b8bbf935	2026-02-06	Warnings, Adverse reactions	Exact identifier application number: M003
70% Rubbing	ISOPROPYL ALCOHOL	Walgreens Co.	6ad37d18-5c19-4b5f-8313-edd430f84fb0	2026-02-05	Warnings, Adverse reactions	Exact identifier application number: M003
Isopropyl Alcohol	ISOPROPYL ALCOHOL	Walgreens Co.	1473e6e4-dc5f-43d9-a249-111a181e3f76	2026-02-05	Warnings, Adverse reactions	Exact identifier application number: M003
Aquarrelle Antibacterial Wipes 40	BENZALKONIUM CHLORIDE	Kimberly-Clark De Mexico, S.A.B.deC.V.	3584680e-71b0-23b6-e063-6294a90a6998	2026-02-05	Warnings	Exact identifier application number: M003
Aquarrelle Antibacterial Wipes 20	BENZALKONIUM CHLORIDE	Kimberly-Clark De Mexico, S.A.B.deC.V.	35865d33-a99f-1b37-e063-6394a90a00d2	2026-02-05	Warnings	Exact identifier application number: M003
Hand Sanitizer Cherry Pop	ALCOHOL	Scent Theory Products LLC	4a18b475-fd3b-10a3-e063-6294a90a4f47	2026-02-05	Warnings	Exact identifier application number: M003
Hand Sanitizer Ocean Splash	ALCOHOL	Scent Theory Products LLC	4a18d7b2-94ca-7924-e063-6394a90af3d1	2026-02-05	Warnings	Exact identifier application number: M003
Hand Sanitizer Banana Creme	ALCOHOL	Scent Theory Products LLC	4a18e8e0-43e3-70d8-e063-6294a90adf4b	2026-02-05	Warnings	Exact identifier application number: M003
Hand Sanitizer Juicy Pear	ALCOHOL	Scent Theory Products LLC	4a18e8e0-43e5-70d8-e063-6294a90adf4b	2026-02-05	Warnings	Exact identifier application number: M003
Hand Sanitizer Pink Melon	ALCOHOL	Scent Theory Products LLC	4a18ec9c-d466-63c1-e063-6294a90a1122	2026-02-05	Warnings	Exact identifier application number: M003
Isopropyl Alcohol	ISOPROPYL ALCOHOL	Pharmacy Value Alliance, LLC	528011d7-8c6d-4940-bee1-52b39acef40d	2026-02-05	Warnings, Adverse reactions	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