Instant Hand Antiseptic

Product NDC: 59448-002
11-digit product format: 594480002
Labeler code: 59448
Product ID: 59448-002_0fcbb981-7868-4c18-bbfa-10870eb1eadf
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: 2018-06-01
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
4eef4b0f-9209-45a4-8a0e-7891fc380fe5	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
6bd95106-a412-1dad-b9cc-4cb74bfb27ce	Product name	2	20230315
444b3e50-f226-46ef-bfca-2e7035d140cd	Product name	1	20190611
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
290f523a-f9db-9774-b5a9-e1f908ac1782	Product name	1	20150828
597b1cfd-7b31-5048-62be-ca5cd740da2f	Product name	1	20140508
c6b65c52-69c7-df49-550a-a50c137f6218	Product name	1	20140508
ec2149b3-5c6d-5344-f757-c86411073075	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
59448-002-01	Englewood Amenity	53 mL in 1 BOTTLE, PLASTIC	GEL	53 mL	0.095 mg in 100mL	8
59448-002-01	Instant Hand Antiseptic	53 mL in 1 BOTTLE, PLASTIC	GEL	53		5
59448-002-01	Englewood Mesh Amenity	53 mL in 1 BOTTLE, PLASTIC	GEL	53 mL	0.095 mg in 100mL	4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
59448-002	ENGLEWOOD AMENITY (BENZALKONIUM CHLORIDE AND SODIUM MONOFLUOROPHOSPHATE) KIT [ASP GLOBAL, LLC]	8	Current NDC, Legacy NDC	20241222_7c9ce1bf-6aa2-4073-ad09-2ddf845102a2.zip
59448-002	INSTANT HAND ANTISEPTIC (BENZALKONIUM CHLORIDE) GEL [ASP GLOBAL]	5	Current NDC, Legacy NDC, 1 package rows	20241207_4eef4b0f-9209-45a4-8a0e-7891fc380fe5.zip
59448-002	ENGLEWOOD MESH AMENITY (BENZALKONIUM CHLORIDE AND SODIUM MONOFLUOROPHOSPHATE) KIT [ASP GLOBAL, LLC]	3	Current NDC, Legacy NDC	20191010_a737fe63-6285-41ee-9516-9c3030a0ab48.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 115 of 115 · 2,286 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Povidone-Iodine Pad	POVIDONE-IODINE	Shandong Haiyan Medical Manufacture Co., Ltd.	c9187a07-92d5-15ac-e053-2995a90af4cb	2022-03-19	Warnings	Exact identifier application number: M003
Alcohol Prep Pad	ISOPROPYL ALCOHOL	Shandong Haiyan Medical Manufacture Co., Ltd.	1a117840-22d0-4a88-b1a6-e43162a444ab	2022-03-19	Warnings	Exact identifier application number: M003
FIRSTAR BZK Antiseptic Towelette	BENZALKONIUM CHLORIDE	JIANGMEN SHUIZIRUN SANITARY ARTICLES CO., LTD.	28591a97-9291-48c8-a8e3-c419180331b3	2021-07-06	Warnings	Exact identifier application number: M003
Bactine Max	BENZALKONIUM CHLORIDE AND LIDOCAINE HYDROCHLORIDE	WellSpring Pharmaceutical Corporation	28e8a311-20a4-45a1-8d5d-ca42b101c275	2021-02-24	Warnings	Exact identifier application number: M003
Hand Sanitizer Lemon 2oz	ALCOHOL	Ningbo Rejoice International	b0a4159a-cb07-4ce6-e053-2995a90a76e7	2020-10-02	Warnings	Exact identifier application number: M003
Sanix Alcohol Hand Rub	ALCOHOL	Topiderm, Inc	a4fbb714-4f20-400a-ab98-f1c8807ce6fc	2020-03-24	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	7c9ce1bf-6aa2-4073-ad09-2ddf845102a2	8
545626	sodium monofluorophosphate 0.76 % Toothpaste	PSN	7c9ce1bf-6aa2-4073-ad09-2ddf845102a2	8
2048259	benzalkonium chloride 0.00095 MG/MG Topical Gel	SCD	7c9ce1bf-6aa2-4073-ad09-2ddf845102a2	8
545626	sodium monofluorophosphate 0.0076 MG/MG Toothpaste	SCD	7c9ce1bf-6aa2-4073-ad09-2ddf845102a2	8
2048259	benzalkonium chloride 0.095 % Topical Gel	SY	7c9ce1bf-6aa2-4073-ad09-2ddf845102a2	8
545626	sodium monofluorophosphate 0.76 % (fluoride ion 0.12 % )Toothpaste	SY	7c9ce1bf-6aa2-4073-ad09-2ddf845102a2	8
545626	sodium monofluorophosphate 0.76 % (fluoride ion 0.13 % )Toothpaste	SY	7c9ce1bf-6aa2-4073-ad09-2ddf845102a2	8
545626	sodium monofluorophosphate 0.76 % (fluoride ion 0.14 % )Toothpaste	SY	7c9ce1bf-6aa2-4073-ad09-2ddf845102a2	8
545626	sodium monofluorophosphate 0.76 % (fluoride ion 0.15 % )Toothpaste	SY	7c9ce1bf-6aa2-4073-ad09-2ddf845102a2	8
2048259	benzalkonium chloride 0.095 % Topical Gel	PSN	4eef4b0f-9209-45a4-8a0e-7891fc380fe5	5
2048259	benzalkonium chloride 0.00095 MG/MG Topical Gel	SCD	4eef4b0f-9209-45a4-8a0e-7891fc380fe5	5
2048259	benzalkonium chloride 0.095 % Topical Gel	SY	4eef4b0f-9209-45a4-8a0e-7891fc380fe5	5
2048259	benzalkonium chloride 0.095 % Topical Gel	PSN	a737fe63-6285-41ee-9516-9c3030a0ab48	4
545626	sodium monofluorophosphate 0.76 % Toothpaste	PSN	a737fe63-6285-41ee-9516-9c3030a0ab48	4
2048259	benzalkonium chloride 0.00095 MG/MG Topical Gel	SCD	a737fe63-6285-41ee-9516-9c3030a0ab48	4
545626	sodium monofluorophosphate 0.0076 MG/MG Toothpaste	SCD	a737fe63-6285-41ee-9516-9c3030a0ab48	4
2048259	benzalkonium chloride 0.095 % Topical Gel	SY	a737fe63-6285-41ee-9516-9c3030a0ab48	4
545626	sodium monofluorophosphate 0.76 % (fluoride ion 0.12 % )Toothpaste	SY	a737fe63-6285-41ee-9516-9c3030a0ab48	4
545626	sodium monofluorophosphate 0.76 % (fluoride ion 0.13 % )Toothpaste	SY	a737fe63-6285-41ee-9516-9c3030a0ab48	4
545626	sodium monofluorophosphate 0.76 % (fluoride ion 0.14 % )Toothpaste	SY	a737fe63-6285-41ee-9516-9c3030a0ab48	4
545626	sodium monofluorophosphate 0.76 % (fluoride ion 0.15 % )Toothpaste	SY	a737fe63-6285-41ee-9516-9c3030a0ab48	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
59448-002-01	59448000201	53 mL in 1 BOTTLE, PLASTIC (59448-002-01)	53 ml	2018-06-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Englewood Mesh Amenity Kit	ASP Global, LLc \| Shengzhou Kingbird Travel Products Co., Ltd. \| Colgate-Palmolive (Thailand) LTD \| Nantong Health & Beyond Hygienic Products Inc.	2025-12-29	HUMAN OTC DRUG LABEL	4
Englewood 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	8
Instant Hand Antiseptic	ASP Global \| Nantong Health & Beyond Hygienic Products Inc.	2024-12-05	HUMAN OTC DRUG LABEL	5