Instant Hand Antiseptic

Product NDC: 59448-004
11-digit product format: 594480004
Labeler code: 59448
Product ID: 59448-004_b6a8ec30-bff9-4cd3-bb2b-584726d227c6
Type: HUMAN OTC DRUG
Nonproprietary name: Alcohol
Dosage form: GEL
Route: TOPICAL
Labeler: ASP Global
Application: M003
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2019-10-15
Substance: ALCOHOL
Active strength: 62 mL/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
ALCOHOL	62 mL/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
3K9958V90M	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
581660	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
b84075db-be0c-4265-b262-825bc6ade9d8	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
444b3e50-f226-46ef-bfca-2e7035d140cd	Product name	1	20190611
597b1cfd-7b31-5048-62be-ca5cd740da2f	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
59448-004-01	Instant Hand Antiseptic	53 mL in 1 BOTTLE, PLASTIC	GEL	53		5
59448-004-01	Emory Johns Creek Amenity	53 mL in 1 BOTTLE, PLASTIC	GEL	53 mL	62 mL in 100mL	4
59448-004-01	Sarasota Memorial Amenity	53 mL in 1 BOTTLE, PLASTIC	GEL	53 mL	62 mL in 100mL	4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
59448-004	INSTANT HAND ANTISEPTIC (ALCOHOL) GEL [ASP GLOBAL]	5	Current NDC, Legacy NDC, 1 package rows	20241208_b84075db-be0c-4265-b262-825bc6ade9d8.zip
59448-004	EMORY JOHNS CREEK AMENITY (ALCOHOL AND SODIUM MONOFLUOROPHOSPATE) KIT [ASP GLOBAL]	4	Current NDC, Legacy NDC	20241222_952ccb85-71bb-4d5d-ac9b-62851a39d36d.zip
59448-004	SARASOTA MEMORIAL AMENITY (ALCOHOL AND SODIUM MONOFLUOROPHOSPHATE) KIT [ASP GLOBAL, LLC]	4	Current NDC, Legacy NDC	20241222_f5dda019-fcfd-4e99-89cc-e79e76b402e7.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 105 of 114 · 2,277 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Novex Hand Sanitizer	BENZALKONIUM CHLORIDE	Natural Essentials, Inc.	8b53dde5-c9f6-41c4-8ddb-bf0bf67008d3	2024-03-20	Warnings	Exact identifier application number: M003
Antiseptic	BENZALKONIUM CHLORIDE 0.13%	Trifecta Pharmaceuticals USA, LLC.	13f1c70f-3b44-8eef-e063-6294a90af634	2024-03-18	Warnings	Exact identifier application number: M003
Burn Cream	BENZALKONIUM CHLORIDE, LIDOCAINE HCI	Trifecta Pharmaceuticals USA LLC	1308ce91-2858-310a-e063-6394a90a6810	2024-03-06	Warnings	Exact identifier application number: M003
Instant Hand Sanitizer - Cocoa Butter	ETHYL ALCOHOL	Rejoice International, Inc.	97dee45e-53be-4b37-a427-fc24388c0e05	2024-02-28	Warnings	Exact identifier application number: M003
Instant Hand Sanitizer Aloe Vera	ETHYL ALCOHOL	Rejoice International, Inc.	1e28454c-f5d8-4d6e-91f9-bc4501b027c1	2024-02-28	Warnings	Exact identifier application number: M003
Instant Hand Sanitizer - Clear	ETHYL ALCOHOL	Rejoice International, Inc.	f0e637d9-d61e-466d-9e05-f906639dbaca	2024-02-28	Warnings	Exact identifier application number: M003
Instant Hand Sanitizer	ETHYL ALCOHOL	Rejoice International, Inc.	07b163e4-8f67-44e7-b5ef-f237023080e0	2024-02-28	Warnings	Exact identifier application number: M003
Instant Hand Sanitizer - Ice Clear	ETHYL ALCOHOL	Rejoice International, Inc.	605ec88a-2f4c-4716-8522-eb2748b43398	2024-02-28	Warnings	Exact identifier application number: M003
Instant Hand Sanitizer - Original	ETHYL ALCOHOL	Rejoice International, Inc.	bb9cc886-275e-4996-99dc-529f928b4905	2024-02-28	Warnings	Exact identifier application number: M003
Liquid Hand Cleanse	TRICLOSAN	Rejoice International, Inc.	23ff5450-8308-41c0-9052-1ac4c4433d6c	2024-02-28	Warnings	Exact identifier application number: M003
XtraCare Antibacterial Hand Cleanse Original	TRICLOSAN	Rejoice International, Inc.	b5ce6663-fe82-4da1-923e-acea293d7a00	2024-02-28	Warnings	Exact identifier application number: M003
XtraCare Antibacterial Hand Cleanse Strawberry Pomegranate	TRICLOSAN	Rejoice International, Inc.	b68a7d64-2650-4fc6-a89e-05de9098a2a3	2024-02-28	Warnings	Exact identifier application number: M003
XtraCare Antibacterial Hand Cleanse Mountain Spring	TRICLOSAN	Rejoice International, Inc.	c31723d5-a313-448a-8b69-ca5f8dec25ed	2024-02-28	Warnings	Exact identifier application number: M003
XtraCare Foam Antibacterial Hand Wash Pink Cherry Blossom	BENZALKONIUM CHLORIDE	Rejoice International	a9a1467c-abcc-4ccb-88f6-430279609788	2024-02-28	Warnings	Exact identifier application number: M003
XtraCare Foam Antibacterial Hand Wash Refill Pink Cherry Blossom	BENZALKONIUM CHLORIDE	Rejoice International	9fa9d955-7167-4a0a-935b-2a600f439eb0	2024-02-28	Warnings	Exact identifier application number: M003
XtraCare Foam Antibacterial Hand Wash Refill Vanilla Passion Flower	BENZALKONIUM CHLORIDE	Rejoice International	157a14bf-f46e-49f8-96f4-a6c472eb5cb8	2024-02-28	Warnings	Exact identifier application number: M003
XtraCare Foaming Hand Sanitizer	BENZALKONIUM CHLORIDE	Rejoice International	3082cbbb-a0ed-45eb-a116-ad1c65357dd1	2024-02-28	Warnings	Exact identifier application number: M003
XtraCare Foam Antibacterial Hand Wash Refill Wild Berry Blast	BENZALKONIUM CHLORIDE	Rejoice International	45b3ca49-edb4-4840-b857-d24045494a3a	2024-02-28	Warnings	Exact identifier application number: M003
XtraCare Foam Antibacterial Hand Wash Vanilla Passion Flower	BENZALKONIUM CHLORIDE	Rejoice International	4890f81e-7994-4ea2-9412-5614c405a2a3	2024-02-28	Warnings	Exact identifier application number: M003
XtraCare Foam Antibacterial Hand Wash Wild Berry Blast	BENZALKONIUM CHLORIDE	Rejoice International	5c109f7c-1f4d-484a-b6ea-3bbcf572bbac	2024-02-28	Warnings	Exact identifier application number: M003

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
3K9958V90M	ALCOHOL	64-17-5	ALCOHOL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
581660	ethanol 62 % Topical Gel	PSN	b84075db-be0c-4265-b262-825bc6ade9d8	5
581660	ethanol 0.62 ML/ML Topical Gel	SCD	b84075db-be0c-4265-b262-825bc6ade9d8	5
581660	ethanol 62 % Topical Gel	SY	b84075db-be0c-4265-b262-825bc6ade9d8	5
581660	ethanol 62 % Topical Gel	PSN	f5dda019-fcfd-4e99-89cc-e79e76b402e7	4
581660	ethanol 62 % Topical Gel	PSN	952ccb85-71bb-4d5d-ac9b-62851a39d36d	4
545626	sodium monofluorophosphate 0.76 % Toothpaste	PSN	f5dda019-fcfd-4e99-89cc-e79e76b402e7	4
545626	sodium monofluorophosphate 0.76 % Toothpaste	PSN	952ccb85-71bb-4d5d-ac9b-62851a39d36d	4
581660	ethanol 0.62 ML/ML Topical Gel	SCD	952ccb85-71bb-4d5d-ac9b-62851a39d36d	4
581660	ethanol 0.62 ML/ML Topical Gel	SCD	f5dda019-fcfd-4e99-89cc-e79e76b402e7	4
545626	sodium monofluorophosphate 0.0076 MG/MG Toothpaste	SCD	952ccb85-71bb-4d5d-ac9b-62851a39d36d	4
545626	sodium monofluorophosphate 0.0076 MG/MG Toothpaste	SCD	f5dda019-fcfd-4e99-89cc-e79e76b402e7	4
581660	ethanol 62 % Topical Gel	SY	952ccb85-71bb-4d5d-ac9b-62851a39d36d	4
581660	ethanol 62 % Topical Gel	SY	f5dda019-fcfd-4e99-89cc-e79e76b402e7	4
545626	sodium monofluorophosphate 0.76 % (fluoride ion 0.12 % )Toothpaste	SY	952ccb85-71bb-4d5d-ac9b-62851a39d36d	4
545626	sodium monofluorophosphate 0.76 % (fluoride ion 0.12 % )Toothpaste	SY	f5dda019-fcfd-4e99-89cc-e79e76b402e7	4
545626	sodium monofluorophosphate 0.76 % (fluoride ion 0.13 % )Toothpaste	SY	952ccb85-71bb-4d5d-ac9b-62851a39d36d	4
545626	sodium monofluorophosphate 0.76 % (fluoride ion 0.13 % )Toothpaste	SY	f5dda019-fcfd-4e99-89cc-e79e76b402e7	4
545626	sodium monofluorophosphate 0.76 % (fluoride ion 0.14 % )Toothpaste	SY	f5dda019-fcfd-4e99-89cc-e79e76b402e7	4
545626	sodium monofluorophosphate 0.76 % (fluoride ion 0.14 % )Toothpaste	SY	952ccb85-71bb-4d5d-ac9b-62851a39d36d	4
545626	sodium monofluorophosphate 0.76 % (fluoride ion 0.15 % )Toothpaste	SY	f5dda019-fcfd-4e99-89cc-e79e76b402e7	4
545626	sodium monofluorophosphate 0.76 % (fluoride ion 0.15 % )Toothpaste	SY	952ccb85-71bb-4d5d-ac9b-62851a39d36d	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
59448-004-01	59448000401	53 mL in 1 BOTTLE, PLASTIC (59448-004-01)	53 ml	2019-10-15	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Sarasota Memorial 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	4
Instant Hand Antiseptic	ASP Global	2024-12-06	HUMAN OTC DRUG LABEL	5
Emory Johns Creek Amenity Kit	ASP Global \| Shengzhou Kingbird Travel Products Co., Ltd. \| Colgate-Palmolive (Thailand) LTD \| Nantong Health & Beyond Hygienic Products Inc.	2024-12-04	HUMAN OTC DRUG LABEL	4