Instant Hand Antiseptic

Product NDC: 59448-003
11-digit product format: 594480003
Labeler code: 59448
Product ID: 59448-003_c5011eba-9aad-4a0c-a4e1-40b10df0402c
Type: HUMAN OTC DRUG
Nonproprietary name: Benzalkonium Chloride
Dosage form: GEL
Route: TOPICAL
Labeler: ASP Global
Application: M003
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2018-11-27
Substance: BENZALKONIUM CHLORIDE
Active strength: .095 mg/100mL
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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: Instant Hand Antiseptic
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
BENZALKONIUM CHLORIDE	.095 mg/100mL

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
2048259	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
47276148-08e5-400e-94ac-d2d9db423b51	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
59448-003-01	Univ of Vermont Medical Center Amenity	53 mL in 1 BOTTLE, PLASTIC	GEL	53 mL	0.095 mg in 100mL	5
59448-003-01	Instant Hand Antiseptic	53 mL in 1 BOTTLE, PLASTIC	GEL	53		5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
59448-003	INSTANT HAND ANTISEPTIC (BENZALKONIUM CHLORIDE) GEL [ASP GLOBAL]	5	Current NDC, Legacy NDC, 1 package rows	20241208_47276148-08e5-400e-94ac-d2d9db423b51.zip
59448-003	UNIV OF VERMONT MEDICAL CENTER AMENITY (BENZALKONIUM CHLORIDE AND SODIUM MONOFLUOROPHOSPHATE) KIT [ASP GLOBAL, LLC]	5	Current NDC, Legacy NDC	20241222_7841cfa9-e94e-4c3d-b5fb-676924017845.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 103 of 115 · 2,286 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Dermal Wound Cleanser	BENZETHONIUM CHLORIDE	Smith & Nephew Medical Ltd.	18704cd5-1ecf-4e8c-9897-7e45394e68c8	2024-07-15	Warnings	Exact identifier application number: M003
Novex Anti-Bacterial Hand Sanitizer Wipe	BENZALKONIUM CHLORIDE	JIANGMEN SHUIZIRUN SANITARY ARTICLES CO., LTD.	7832a0be-a8ce-4b56-a9bb-a375b97df287	2024-07-10	Warnings	Exact identifier application number: M003
Callington Anti-Bacterial Hand Sanitizer Wipe	BENZALKONIUM CHLORIDE	JIANGMEN SHUIZIRUN SANITARY ARTICLES CO., LTD.	00ca48ca-893d-4a3f-ad90-119522664e08	2024-07-10	Warnings	Exact identifier application number: M003
Assorted Licensed Hand Sanitizer Grape 01	ALCOHOL	Shenzhen Lantern Scicence Co.,Ltd.	1c9095ad-ce19-3666-e063-6394a90ae22d	2024-07-09	Warnings	Exact identifier application number: M003
AMORAY 70% ETHYL ALCOHOL HAND SANITIZER FRESH CITRUS	ETHYL ALCOHOL	MY IMPORTS USA LLC	1ccb78ed-36f9-a7d2-e063-6394a90a6477	2024-07-09	Warnings	Exact identifier application number: M003
AMORAY 70% ETHYL ALCOHOL HAND SANITIZER LAVENDER	ETHYL ALCOHOL	MY IMPORTS USA LLC	1ccb9671-1970-39f9-e063-6294a90ac079	2024-07-09	Warnings	Exact identifier application number: M003
AMORAY 70% ETHYL ALCOHOL HAND SANITIZER STRAWBERRY	ETHYL ALCOHOL	MY IMPORTS USA LLC	1ccbc68e-2b6b-768c-e063-6294a90a643b	2024-07-09	Warnings	Exact identifier application number: M003
AMORAY 70% ETHYL ALCOHOL HAND SANITIZER ORIGINAL	ETHYL ALCOHOL	MY IMPORTS USA LLC	1ccbbc55-3f7d-76d1-e063-6294a90a5590	2024-07-09	Warnings	Exact identifier application number: M003
AMORAY 70% ETHYL ALCOHOL HAND SANITIZER LAVENDER	ETHYL ALCOHOL	Zhejiang Guoyao Jingyue Aerosol Co., Ltd.	1cb701f7-61c8-e5f4-e063-6294a90a0c3c	2024-07-08	Warnings	Exact identifier application number: M003
AMORAY 70% ETHYL ALCOHOL HAND SANITIZER ORIGINAL	ETHYL ALCOHOL	Zhejiang Guoyao Jingyue Aerosol Co., Ltd.	1cb77267-73ad-efd2-e063-6294a90a43f7	2024-07-08	Warnings	Exact identifier application number: M003
AMORAY 70% ETHYL ALCOHOL HAND SANITIZER STRAWBERRY	ETHYL ALCOHOL	Zhejiang Guoyao Jingyue Aerosol Co., Ltd.	1cb7d6ca-ef7e-5225-e063-6294a90aa692	2024-07-08	Warnings	Exact identifier application number: M003
Assorted Licensed Hand Sanitizer Sweet pea 01	ALCOHOL	Shenzhen Lantern Scicence Co.,Ltd.	1cc8a756-852f-6cf8-e063-6394a90a57e6	2024-07-08	Warnings	Exact identifier application number: M003
Assorted Licensed Hand Sanitizer Vanilla 01	ALCOHOL	Shenzhen Lantern Scicence Co.,Ltd.	1cc90b2f-450f-1deb-e063-6394a90a6480	2024-07-08	Warnings	Exact identifier application number: M003
AMORAY 70% ETHYL ALCOHOL HAND SANITIZER FRESH CITRUS	ETHYL ALCOHOL	Zhejiang Guoyao Jingyue Aerosol Co., Ltd.	1cb4316d-c8c6-3fa2-e063-6394a90a23d2	2024-07-07	Warnings	Exact identifier application number: M003
Antibacterial Hand Sanitizer	ALCOHOL	Cosmuses Cosmetics (Ningbo) Co., Ltd	f531053d-82e4-7613-e053-2995a90a349f	2024-07-02	Warnings	Exact identifier application number: M003
Antibacterial Hand Sanitizer	ALCOHOL	Cosmuses Cosmetics (Ningbo) Co., Ltd	1ae5c268-1834-4ac2-931e-bb7fd0088cd2	2024-07-02	Warnings	Exact identifier application number: M003
Quality Choice	ISOPROPYL ALCOHOL	Chain Drug Marketing Association Inc	1262c5d7-63ef-f1c1-e063-6294a90a1f0f	2024-07-02	Warnings	Exact identifier application number: M003
Genuine First Aid Antiseptic Towelette	BENZALKONIUM CHLORIDE	GFA Production (Xiamen) Co., Ltd.	dfff78d2-e23c-40b2-8a49-8f4140bb0df6	2024-06-25	Warnings	Exact identifier application number: M003
Walgreens 3 Hydrogen Peroxide Wipes	HYDROGEN PEROXIDE	Walgreen Company	03c497cc-c8b1-43b7-86ba-f9f9fc7432bf	2024-06-18	Warnings	Exact identifier application number: M003
Antimicrobial	BODY CLEANSER	McKesson	8ff06cea-3427-5b40-e053-2995a90a0634	2024-06-17	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
2048259	benzalkonium chloride 0.095 % Topical Gel	PSN	47276148-08e5-400e-94ac-d2d9db423b51	5
2048259	benzalkonium chloride 0.095 % Topical Gel	PSN	7841cfa9-e94e-4c3d-b5fb-676924017845	5
545626	sodium monofluorophosphate 0.76 % Toothpaste	PSN	7841cfa9-e94e-4c3d-b5fb-676924017845	5
2048259	benzalkonium chloride 0.00095 MG/MG Topical Gel	SCD	47276148-08e5-400e-94ac-d2d9db423b51	5
2048259	benzalkonium chloride 0.00095 MG/MG Topical Gel	SCD	7841cfa9-e94e-4c3d-b5fb-676924017845	5
545626	sodium monofluorophosphate 0.0076 MG/MG Toothpaste	SCD	7841cfa9-e94e-4c3d-b5fb-676924017845	5
2048259	benzalkonium chloride 0.095 % Topical Gel	SY	47276148-08e5-400e-94ac-d2d9db423b51	5
2048259	benzalkonium chloride 0.095 % Topical Gel	SY	7841cfa9-e94e-4c3d-b5fb-676924017845	5
545626	sodium monofluorophosphate 0.76 % (fluoride ion 0.12 % )Toothpaste	SY	7841cfa9-e94e-4c3d-b5fb-676924017845	5
545626	sodium monofluorophosphate 0.76 % (fluoride ion 0.13 % )Toothpaste	SY	7841cfa9-e94e-4c3d-b5fb-676924017845	5
545626	sodium monofluorophosphate 0.76 % (fluoride ion 0.14 % )Toothpaste	SY	7841cfa9-e94e-4c3d-b5fb-676924017845	5
545626	sodium monofluorophosphate 0.76 % (fluoride ion 0.15 % )Toothpaste	SY	7841cfa9-e94e-4c3d-b5fb-676924017845	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
59448-003-01	59448000301	53 mL in 1 BOTTLE, PLASTIC (59448-003-01)	53 ml	2018-11-27	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Univ of Vermont Medical Center Amenity Kit	ASP Global, LLc \| Shengzhou Kingbird Travel Products Co., Ltd. \| Colgate-Palmolive (Thailand) LTD \| Nantong Health & Beyond Hygienic Products Inc.	2024-12-17	HUMAN OTC DRUG LABEL	5
Instant Hand Antiseptic	ASP Global \| Nantong Health & Beyond Hygienic Products Inc.	2024-12-06	HUMAN OTC DRUG LABEL	5