Hand Sanitizer

Product NDC: 80589-001
11-digit product format: 805890001
Labeler code: 80589
Product ID: 80589-001_c4422855-4152-f2d6-e053-2995a90a2093
Type: HUMAN OTC DRUG
Nonproprietary name: Ethyl Alcohol
Dosage form: GEL
Route: TOPICAL
Labeler: Black Irish Products
Application: part333A
Marketing category: OTC MONOGRAPH NOT FINAL
Marketing start: 2020-03-29
Marketing end: 0000-00-00
Substance: ALCOHOL
Active strength: 75 mL/100mL
NDC exclude flag: No
Listing certified through: 2022-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 10 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	80589-001		I	Inactivated by FDA	2026-10-05
excluded product	product	80589-001		I	Inactivated by FDA	2026-10-05
excluded package	package	80589-001	80589-001-01	I	Inactivated by FDA	2026-10-05
excluded package	package	80589-001	80589-001-02	I	Inactivated by FDA	2026-10-05
excluded package	package	80589-001	80589-001-03	I	Inactivated by FDA	2026-10-05
excluded package	package	80589-001	80589-001-04	I	Inactivated by FDA	2026-10-05
excluded package	package	80589-001	80589-001-05	I	Inactivated by FDA	2026-10-05
excluded package	package	80589-001	80589-001-06	I	Inactivated by FDA	2026-10-05
excluded package	package	80589-001	80589-001-07	I	Inactivated by FDA	2026-10-05
excluded package	package	80589-001	80589-001-08	I	Inactivated by FDA	2026-10-05

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 3 · 150 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	80589-001-08	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	80589-001-06	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	80589-001-04	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	80589-001-07	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	80589-001-01	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	80589-001-03	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	80589-001-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	80589-001-02	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	80589-001-08	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	80589-001-06	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	80589-001-04	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	80589-001-07	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	80589-001-01	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	80589-001-03	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	80589-001-05	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	80589-001-02	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	80589-001-08	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	80589-001-06	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	80589-001-04	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	80589-001-07	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	80589-001-01	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	80589-001-03	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	80589-001-05	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	80589-001-02	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	80589-001-08	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	80589-001-06	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	80589-001-04	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	80589-001-07	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	80589-001-01	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	80589-001-03	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	80589-001-05	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	80589-001-02	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	80589-001-08	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	80589-001-06	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	80589-001-04	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	80589-001-07	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	80589-001-01	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	80589-001-03	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	80589-001-05	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	80589-001-02	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	80589-001-08	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	80589-001-06	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	80589-001-04	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	80589-001-07	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	80589-001-01	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	80589-001-03	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	80589-001-05	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	80589-001-02	`cdf11ea48f46…`	`ba0047e9e063…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

FDA-Initiated Inactive NDC Indexing#

NDC, Indexing SPL, Related label table
NDC	Indexing SPL	Related label
80589-001-01	f386c64a-1ba6-0266-e053-dadaa90a7c1a	be5d0c55-519d-4836-e053-2995a90a6edb
80589-001-02	f386c64a-1ba6-0266-e053-dadaa90a7c1a	be5d0c55-519d-4836-e053-2995a90a6edb
80589-001-03	f386c64a-1ba6-0266-e053-dadaa90a7c1a	be5d0c55-519d-4836-e053-2995a90a6edb
80589-001-04	f386c64a-1ba6-0266-e053-dadaa90a7c1a	be5d0c55-519d-4836-e053-2995a90a6edb
80589-001-05	f386c64a-1ba6-0266-e053-dadaa90a7c1a	be5d0c55-519d-4836-e053-2995a90a6edb
80589-001-06	f386c64a-0780-0266-e053-dadaa90a7c1a	c4439dc1-965d-0b8c-e053-2995a90a2457
80589-001-07	f386c64a-0780-0266-e053-dadaa90a7c1a	c4439dc1-965d-0b8c-e053-2995a90a2457
80589-001-08	f386c64a-0780-0266-e053-dadaa90a7c1a	c4439dc1-965d-0b8c-e053-2995a90a2457

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
80589-001-01	Hand Sanitizer	236 mL in 1 BOTTLE, PUMP	GEL	236	1
80589-001-02	Hand Sanitizer	59 mL in 1 BOTTLE	GEL	59	1
80589-001-03	Hand Sanitizer	3785 mL in 1 BOTTLE, PUMP	GEL	3785	1
80589-001-04	Hand Sanitizer	59 mL in 1 BOTTLE	GEL	59	1
80589-001-05	Hand Sanitizer	133 mL in 1 POUCH	GEL	133	1
80589-001-06	Hand Sanitizer	946 mL in 1 BOTTLE, PUMP	GEL	946	1
80589-001-07	Hand Sanitizer	532 mL in 1 BOTTLE, PUMP	GEL	532	1
80589-001-08	Hand Sanitizer	236 mL in 1 BOTTLE, PUMP	GEL	236	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
80589-001	HAND SANITIZER (ETHYL ALCOHOL) GEL [BLACK IRISH PRODUCTS, LLC.]	1	Legacy NDC, 5 package rows	20210604_be5d0c55-519d-4836-e053-2995a90a6edb.zip
80589-001	HAND SANITIZER (ETHYL ALCOHOL) GEL [BLACK IRISH PRODUCTS]	1	Legacy NDC, 3 package rows	20210616_c4439dc1-965d-0b8c-e053-2995a90a2457.zip

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
1305100	ethanol 75 % Topical Gel	PSN	be5d0c55-519d-4836-e053-2995a90a6edb	1
1305100	ethanol 75 % Topical Gel	PSN	c4439dc1-965d-0b8c-e053-2995a90a2457	1
1305100	ethanol 0.75 ML/ML Topical Gel	SCD	be5d0c55-519d-4836-e053-2995a90a6edb	1
1305100	ethanol 0.75 ML/ML Topical Gel	SCD	c4439dc1-965d-0b8c-e053-2995a90a2457	1
1305100	ethanol 75 % Topical Gel	SY	be5d0c55-519d-4836-e053-2995a90a6edb	1
1305100	ethanol 75 % Topical Gel	SY	c4439dc1-965d-0b8c-e053-2995a90a2457	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
80589-001-01	80589000101	236 mL in 1 BOTTLE, PUMP (80589-001-01)	236 ml	2021-03-29	0000-00-00	No	No	Current
80589-001-02	80589000102	59 mL in 1 BOTTLE (80589-001-02)	59 ml	2021-03-29	0000-00-00	No	No	Current
80589-001-03	80589000103	3785 mL in 1 BOTTLE, PUMP (80589-001-03)	3785 ml	2021-03-29	0000-00-00	No	No	Current
80589-001-04	80589000104	59 mL in 1 BOTTLE (80589-001-04)	59 ml	2021-03-29	0000-00-00	No	No	Current
80589-001-05	80589000105	133 mL in 1 POUCH (80589-001-05)	133 ml	2021-03-29	0000-00-00	No	No	Current
80589-001-06	80589000106	946 mL in 1 BOTTLE, PUMP (80589-001-06)	946 ml	2020-03-29	0000-00-00	No	No	Current
80589-001-07	80589000107	532 mL in 1 BOTTLE, PUMP (80589-001-07)	532 ml	2020-03-29	0000-00-00	No	No	Current
80589-001-08	80589000108	236 mL in 1 BOTTLE, PUMP (80589-001-08)	236 ml	2020-03-29	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Hand Sanitizer - Black Irish Products \| Redi-2-PaQ Home Products, LLC.	Black Irish Products \| Redi-2-PaQ Home Products, LLC.	2021-06-08	HUMAN OTC DRUG LABEL	1
WATER - Black Irish Products, LLC. \| Redi-2-PaQ Home Products, LLC. \| Black Irish Products	Black Irish Products, LLC. \| Redi-2-PaQ Home Products, LLC. \| Black Irish Products	2021-03-25	HUMAN OTC DRUG LABEL	1