Hand Sanitizer

Product NDC: 54586-002
11-digit product format: 545860002
Labeler code: 54586
Product ID: 54586-002_ac0984a1-640c-6425-e053-2995a90a1a43
Type: HUMAN OTC DRUG
Nonproprietary name: Hand Sanitizer
Dosage form: GEL
Route: EXTRACORPOREAL
Labeler: Chengdu Rosun Disinfection Pharmaceutical Co., Ltd.
Application: part333E
Marketing category: OTC MONOGRAPH NOT FINAL
Marketing start: 2020-08-04
Marketing end: 0000-00-00
Substance: ALCOHOL
Active strength: 375 mL/500mL
NDC exclude flag: No
Listing certified through: 2021-12-31
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 · 8 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	54586-002		I	Inactivated by FDA	2026-10-05
excluded product	product	54586-002		I	Inactivated by FDA	2026-10-05
excluded product	product	54586-002		I	Inactivated by FDA	2026-10-05
excluded product	product	54586-002		I	Inactivated by FDA	2026-10-05
excluded package	package	54586-002	54586-002-01	I	Inactivated by FDA	2026-10-05
excluded package	package	54586-002	54586-002-02	I	Inactivated by FDA	2026-10-05
excluded package	package	54586-002	54586-002-03	I	Inactivated by FDA	2026-10-05
excluded package	package	54586-002	54586-002-04	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 · 144 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 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	54586-002-04	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	54586-002-02	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	54586-002-03	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	54586-002-01	`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 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	54586-002-04	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	54586-002-02	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	54586-002-03	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	54586-002-01	`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 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	54586-002-04	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	54586-002-02	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	54586-002-03	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	54586-002-01	`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 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	54586-002-04	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	54586-002-02	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	54586-002-03	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	54586-002-01	`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 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	54586-002-04	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	54586-002-02	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	54586-002-03	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	54586-002-01	`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 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	54586-002-04	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	54586-002-02	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	54586-002-03	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	54586-002-01	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	54586-002-04	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	54586-002-02	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	54586-002-03	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	54586-002-01	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`

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
54586-002-01	d6a99b39-57b3-a426-e053-dadaa90af4c2	a4458ed8-a3ad-1790-e053-2a95a90aee6b
54586-002-02	d6a99b39-7849-a426-e053-dadaa90af4c2	ac0984a1-640b-6425-e053-2995a90a1a43
54586-002-03	d6a99b39-f931-a426-e053-dadaa90af4c2	ac0a0851-ba86-7f36-e053-2995a90ae391
54586-002-04	d6a99b39-7855-a426-e053-dadaa90af4c2	ac0a0851-ba89-7f36-e053-2995a90ae391

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
54586-002-01	Hand Sanitizer	500 mL in 1 BOTTLE	GEL	500	2
54586-002-02	Hand Sanitizer	500 mL in 1 BOTTLE	GEL	500	1
54586-002-03	Hand Sanitizer	500 mL in 1 BOTTLE	GEL	500	1
54586-002-04	Hand Sanitizer	500 mL in 1 BOTTLE	GEL	500	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
54586-002	HAND SANITIZER GEL [CHENGDU ROSUN DISINFECTION PHARMACEUTICAL CO., LTD.]	2	Legacy NDC, 1 package rows	20200518_a4458ed8-a3ad-1790-e053-2a95a90aee6b.zip
54586-002	HAND SANITIZER GEL [CHENGDU ROSUN DISINFECTION PHARMACEUTICAL CO., LTD.]	1	Legacy NDC, 1 package rows	20200805_ac0a0851-ba86-7f36-e053-2995a90ae391.zip
54586-002	HAND SANITIZER GEL [CHENGDU ROSUN DISINFECTION PHARMACEUTICAL CO., LTD.]	1	Legacy NDC, 1 package rows	20200805_ac0984a1-640b-6425-e053-2995a90a1a43.zip
54586-002	HAND SANITIZER GEL [CHENGDU ROSUN DISINFECTION PHARMACEUTICAL CO., LTD.]	1	Legacy NDC, 1 package rows	20200805_ac0a0851-ba89-7f36-e053-2995a90ae391.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	a4458ed8-a3ad-1790-e053-2a95a90aee6b	2
1305100	ethanol 0.75 ML/ML Topical Gel	SCD	a4458ed8-a3ad-1790-e053-2a95a90aee6b	2
1305100	ethanol 75 % Topical Gel	SY	a4458ed8-a3ad-1790-e053-2a95a90aee6b	2
1305100	ethanol 75 % Topical Gel	PSN	ac0984a1-640b-6425-e053-2995a90a1a43	1
1305100	ethanol 75 % Topical Gel	PSN	ac0a0851-ba86-7f36-e053-2995a90ae391	1
1305100	ethanol 75 % Topical Gel	PSN	ac0a0851-ba89-7f36-e053-2995a90ae391	1
1305100	ethanol 0.75 ML/ML Topical Gel	SCD	ac0984a1-640b-6425-e053-2995a90a1a43	1
1305100	ethanol 0.75 ML/ML Topical Gel	SCD	ac0a0851-ba86-7f36-e053-2995a90ae391	1
1305100	ethanol 0.75 ML/ML Topical Gel	SCD	ac0a0851-ba89-7f36-e053-2995a90ae391	1
1305100	ethanol 75 % Topical Gel	SY	ac0984a1-640b-6425-e053-2995a90a1a43	1
1305100	ethanol 75 % Topical Gel	SY	ac0a0851-ba86-7f36-e053-2995a90ae391	1
1305100	ethanol 75 % Topical Gel	SY	ac0a0851-ba89-7f36-e053-2995a90ae391	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
54586-002-01	54586000201	500 mL in 1 BOTTLE (54586-002-01)	500 ml	2020-04-27	0000-00-00	No	No	Current
54586-002-02	54586000202	500 mL in 1 BOTTLE (54586-002-02)	500 ml	2020-08-04	0000-00-00	No	No	Current
54586-002-03	54586000203	500 mL in 1 BOTTLE (54586-002-03)	500 ml	2020-08-04	0000-00-00	No	No	Current
54586-002-04	54586000204	500 mL in 1 BOTTLE (54586-002-04)	500 ml	2020-08-04	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Hand Sanitizer - Chengdu Rosun Disinfection Pharmaceutical Co., Ltd.	Chengdu Rosun Disinfection Pharmaceutical Co., Ltd.	2020-08-04	HUMAN OTC DRUG LABEL	1
Hand Sanitizer - Chengdu Rosun Disinfection Pharmaceutical Co., Ltd.	Chengdu Rosun Disinfection Pharmaceutical Co., Ltd.	2020-08-04	HUMAN OTC DRUG LABEL	1
Hand Sanitizer - Chengdu Rosun Disinfection Pharmaceutical Co., Ltd.	Chengdu Rosun Disinfection Pharmaceutical Co., Ltd.	2020-08-04	HUMAN OTC DRUG LABEL	1
Hand Sanitizer - Chengdu Rosun Disinfection Pharmaceutical Co., Ltd.	Chengdu Rosun Disinfection Pharmaceutical Co., Ltd.	2020-05-18	HUMAN OTC DRUG LABEL	2