Clean Hands Antibacterial Hand Sanitizer

Product NDC: 50563-195
11-digit product format: 505630195
Labeler code: 50563
Product ID: 50563-195_a4c180a1-5bbb-071c-e053-2995a90a5638
Type: HUMAN OTC DRUG
Nonproprietary name: Ethyl Alcohol
Dosage form: GEL
Route: TOPICAL
Labeler: ENCHANTE ACCESSORIES INC.
Application: part333A
Marketing category: OTC MONOGRAPH NOT FINAL
Marketing start: 2020-05-03
Marketing end: 0000-00-00
Substance: ALCOHOL
Active strength: 75 mL/100mL
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 · 9 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	50563-195		I	Inactivated by FDA	2026-10-15
excluded package	package	50563-195	50563-195-01	I	Inactivated by FDA	2026-10-15
excluded package	package	50563-195	50563-195-02	I	Inactivated by FDA	2026-10-15
excluded package	package	50563-195	50563-195-03	I	Inactivated by FDA	2026-10-15
excluded package	package	50563-195	50563-195-04	I	Inactivated by FDA	2026-10-15
excluded package	package	50563-195	50563-195-05	I	Inactivated by FDA	2026-10-15
excluded package	package	50563-195	50563-195-06	I	Inactivated by FDA	2026-10-15
excluded package	package	50563-195	50563-195-07	I	Inactivated by FDA	2026-10-15
excluded package	package	50563-195	50563-195-08	I	Inactivated by FDA	2026-10-15

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 · 162 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 package	package	50563-195-06	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	50563-195-02	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	50563-195-01	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	50563-195-04	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	50563-195-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	50563-195-08	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	50563-195-07	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	50563-195-03	`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 package	package	50563-195-06	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	50563-195-02	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	50563-195-01	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	50563-195-04	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	50563-195-05	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	50563-195-08	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	50563-195-07	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	50563-195-03	`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 package	package	50563-195-06	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	50563-195-02	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	50563-195-01	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	50563-195-04	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	50563-195-05	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	50563-195-08	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	50563-195-07	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	50563-195-03	`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 package	package	50563-195-06	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	50563-195-02	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	50563-195-01	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	50563-195-04	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	50563-195-05	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	50563-195-08	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	50563-195-07	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	50563-195-03	`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 package	package	50563-195-06	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	50563-195-02	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	50563-195-01	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	50563-195-04	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	50563-195-05	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	50563-195-08	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	50563-195-07	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	50563-195-03	`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 package	package	50563-195-06	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	50563-195-02	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	50563-195-01	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	50563-195-04	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	50563-195-05	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	50563-195-08	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	50563-195-07	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	50563-195-03	`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 package	package	50563-195-06	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	50563-195-02	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	50563-195-01	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	50563-195-04	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	50563-195-05	`302b2466d912…`	`e7b80fea0513…`

Reported adverse events (FAERS/openFDA)#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Related label table
NDC	Related label
50563-195-01	d091f2ad-1e94-413a-9001-211b4e271ad9
50563-195-02	d091f2ad-1e94-413a-9001-211b4e271ad9
50563-195-03	d091f2ad-1e94-413a-9001-211b4e271ad9
50563-195-04	d091f2ad-1e94-413a-9001-211b4e271ad9
50563-195-05	d091f2ad-1e94-413a-9001-211b4e271ad9
50563-195-06	d091f2ad-1e94-413a-9001-211b4e271ad9
50563-195-07	d091f2ad-1e94-413a-9001-211b4e271ad9
50563-195-08	d091f2ad-1e94-413a-9001-211b4e271ad9

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
50563-195-01	Clean Hands Antibacterial Hand Sanitizer	200 in 1 CARTON	GEL	200	1
50563-195-01	Clean Hands Antibacterial Hand Sanitizer	30 mL in 1 BOTTLE	GEL	30	1
50563-195-02	Clean Hands Antibacterial Hand Sanitizer	150 in 1 CARTON	GEL	150	1
50563-195-02	Clean Hands Antibacterial Hand Sanitizer	60 mL in 1 BOTTLE	GEL	60	1
50563-195-03	Clean Hands Antibacterial Hand Sanitizer	100 mL in 1 BOTTLE	GEL	100	1
50563-195-03	Clean Hands Antibacterial Hand Sanitizer	100 in 1 CARTON	GEL	100	1
50563-195-04	Clean Hands Antibacterial Hand Sanitizer	237 mL in 1 BOTTLE	GEL	237	1
50563-195-04	Clean Hands Antibacterial Hand Sanitizer	24 in 1 CARTON	GEL	24	1
50563-195-05	Clean Hands Antibacterial Hand Sanitizer	20 in 1 CARTON	GEL	20	1
50563-195-05	Clean Hands Antibacterial Hand Sanitizer	500 mL in 1 BOTTLE	GEL	500	1
50563-195-06	Clean Hands Antibacterial Hand Sanitizer	1000 mL in 1 BOTTLE	GEL	1000	1
50563-195-06	Clean Hands Antibacterial Hand Sanitizer	18 in 1 CARTON	GEL	18	1
50563-195-07	Clean Hands Antibacterial Hand Sanitizer	3780 mL in 1 BOTTLE	GEL	3780	1
50563-195-07	Clean Hands Antibacterial Hand Sanitizer	4 in 1 CARTON	GEL	4	1
50563-195-08	Clean Hands Antibacterial Hand Sanitizer	4 in 1 CARTON	GEL	4	1
50563-195-08	Clean Hands Antibacterial Hand Sanitizer	5000 mL in 1 BOTTLE	GEL	5000	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50563-195	CLEAN HANDS ANTIBACTERIAL HAND SANITIZER (ETHYL ALCOHOL) GEL [ENCHANTE ACCESSORIES INC.]	1	Legacy NDC, 16 package rows	20200504_d091f2ad-1e94-413a-9001-211b4e271ad9.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	d091f2ad-1e94-413a-9001-211b4e271ad9	1
1305100	ethanol 0.75 ML/ML Topical Gel	SCD	d091f2ad-1e94-413a-9001-211b4e271ad9	1
1305100	ethanol 75 % Topical Gel	SY	d091f2ad-1e94-413a-9001-211b4e271ad9	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
50563-195-01	50563019501	200 BOTTLE in 1 CARTON (50563-195-01) > 30 mL in 1 BOTTLE	200 bottle	2020-05-03	0000-00-00	No	No	Current
50563-195-02	50563019502	150 BOTTLE in 1 CARTON (50563-195-02) > 60 mL in 1 BOTTLE	150 bottle	2020-05-03	0000-00-00	No	No	Current
50563-195-03	50563019503	100 BOTTLE in 1 CARTON (50563-195-03) > 100 mL in 1 BOTTLE	100 bottle	2020-05-03	0000-00-00	No	No	Current
50563-195-04	50563019504	24 BOTTLE in 1 CARTON (50563-195-04) > 237 mL in 1 BOTTLE	24 bottle	2020-05-03	0000-00-00	No	No	Current
50563-195-05	50563019505	20 BOTTLE in 1 CARTON (50563-195-05) > 500 mL in 1 BOTTLE	20 bottle	2020-05-03	0000-00-00	No	No	Current
50563-195-06	50563019506	18 BOTTLE in 1 CARTON (50563-195-06) > 1000 mL in 1 BOTTLE	18 bottle	2020-05-03	0000-00-00	No	No	Current
50563-195-07	50563019507	4 BOTTLE in 1 CARTON (50563-195-07) > 3780 mL in 1 BOTTLE	4 bottle	2020-05-03	0000-00-00	No	No	Current
50563-195-08	50563019508	4 BOTTLE in 1 CARTON (50563-195-08) > 5000 mL in 1 BOTTLE	4 bottle	2020-05-03	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
WATER - ENCHANTE ACCESSORIES INC. \| Hangzhou Huiji Biotechnology Co., Ltd.	ENCHANTE ACCESSORIES INC. \| Hangzhou Huiji Biotechnology Co., Ltd.	2020-05-03	HUMAN OTC DRUG LABEL	1