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 13 of 115 · 2,286 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ashley Belle 1 oz., Moisturizing Hand Sanitizing, Pistachio Glow	ETHYL ALCOHOL 70% V/V	MY IMPORTS USA LLC	5599605b-28f0-a534-e063-6394a90a7213	2026-07-01	Warnings	Exact identifier application number: M003
Ashley Belle 1 oz., Moisturizing Hand Sanitizing, Pumpkin Cream	ETHYL ALCOHOL 70% V/V	MY IMPORTS USA LLC	559987c0-7abd-13fc-e063-6294a90a9f27	2026-07-01	Warnings	Exact identifier application number: M003
MISTIFY STRAWBERRE HYDRATING HAND SANITIZER	ALCOHOL ANTISEPTIC	Kingkey MBC Life Technology Group Co.,Ltd	5740a2ed-e77d-3f41-e063-6394a90aec03	2026-07-01	Warnings	Exact identifier application number: M003
MISTIFY VANILLA HYDRATING HAND SANITIZER	ALCOHOL ANTISEPTIC	Kingkey MBC Life Technology Group Co.,Ltd	574ba9b9-b44d-b014-e063-6394a90af768	2026-07-01	Warnings	Exact identifier application number: M003
MISTIFY COTTON CANDY HYDRATING HAND SANITIZER	ALCOHOL ANTISEPTIC	Kingkey MBC Life Technology Group Co.,Ltd	574bcf4f-ad36-5ede-e063-6294a90a0eab	2026-07-01	Warnings	Exact identifier application number: M003
MISTIFY COCONUT HYDRATING HAND SANITIZER	ALCOHOL ANTISEPTIC	Kingkey MBC Life Technology Group Co.,Ltd	57539bdd-641d-3c27-e063-6394a90af84a	2026-07-01	Warnings	Exact identifier application number: M003
Benzethonium chloride Plus Dyclonine hydrochloride	LIQUID BANDAGE	Hudson Health LLC	42789576-0ab4-1afb-e063-6294a90a1d27	2026-06-30	Warnings	Exact identifier application number: M003
Ashley Belle 1 oz., Moisturizing Hand Sanitizing Spray, Sugared Plum	ETHYL ALCOHOL 70% V/V	Zhejiang Guoyao Jingyue Aerosol Co., Ltd.	5572d336-f953-90ac-e063-6394a90a2d4d	2026-06-30	Warnings	Exact identifier application number: M003
McKesson Alcohol Prep Pad	ISOPROPYL ALCOHOL	McKesson Medical-Surgical	a8e759f3-91b1-44ae-960a-3a6cd4f746ce	2026-06-30	Warnings	Exact identifier application number: M003
Tinted Isopropyl Alcohol	ISOPROPYL ALCOHOL	Medical Chemical Corporation	f3c1c8a3-6b34-46cf-845e-c89db8f096f1	2026-06-30	Warnings	Exact identifier application number: M003
Isopropyl Alcohol	ISOPROPYL ALCOHOL	Medical Chemical Corporation	a04239d8-0fa9-4c00-aa81-d7a1242bc931	2026-06-30	Warnings	Exact identifier application number: M003
Ashley Belle 1 oz., Moisturizing Hand Sanitizing, Autumn Berry Crumble	ETHYL ALCOHOL 70% V/V	Zhejiang Guoyao Jingyue Aerosol Co., Ltd.	555da50d-f106-f27f-e063-6294a90a61f9	2026-06-29	Warnings	Exact identifier application number: M003
Ashley Belle 1 oz., Moisturizing Hand Sanitizing, Beach Sandalwood	ETHYL ALCOHOL 70% V/V	Zhejiang Guoyao Jingyue Aerosol Co., Ltd.	55601f99-b1a7-ffb5-e063-6394a90a37d6	2026-06-29	Warnings	Exact identifier application number: M003
Ashley Belle 1 oz., Moisturizing Hand Sanitizing, Confetti Cupcake	ETHYL ALCOHOL 70% V/V	Zhejiang Guoyao Jingyue Aerosol Co., Ltd.	556073a0-242b-dc26-e063-6394a90a9ccf	2026-06-29	Warnings	Exact identifier application number: M003
Ashley Belle 1 oz., Moisturizing Hand Sanitizing, Pumpkin Cream	ETHYL ALCOHOL 70% V/V	Zhejiang Guoyao Jingyue Aerosol Co., Ltd.	55709e6c-e2ec-9c16-e063-6394a90a269e	2026-06-29	Warnings	Exact identifier application number: M003
MedPride Alcohol Wipes	ISOPROPYL ALCOHOL	Shield Line LLC	ad2a29b2-0511-bbe4-e053-2a95a90ac0b1	2026-06-29	Warnings	Exact identifier application number: M003
Iodine Tincture Mild	IODINE AND SODIUM IODIDE AND ALCOHOL	Pharma Nobis, LLC	e42df0bf-cce7-3961-e053-2995a90a730a	2026-06-29	Warnings	Exact identifier application number: M003
Ashley Belle 1 oz., Moisturizing Hand Sanitizing, Berry Creme	ETHYL ALCOHOL 70% V/V	Zhejiang Guoyao Jingyue Aerosol Co., Ltd.	556f24a7-2294-424f-e063-6394a90a0b68	2026-06-29	Warnings	Exact identifier application number: M003
Ashley Belle 1 oz., Moisturizing Hand Sanitizing, Gingerbread Cake	ETHYL ALCOHOL 70% V/V	Zhejiang Guoyao Jingyue Aerosol Co., Ltd.	556fa2a3-38de-1393-e063-6294a90add6a	2026-06-29	Warnings	Exact identifier application number: M003
Ashley Belle 1 oz., Moisturizing Hand Sanitizing, Matcha Mist	ETHYL ALCOHOL 70% V/V	Zhejiang Guoyao Jingyue Aerosol Co., Ltd.	556fcd84-0b0d-ed0b-e063-6394a90a45eb	2026-06-29	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