Hand Sanitizer

Product NDC: 81309-004
11-digit product format: 813090004
Labeler code: 81309
Product ID: 81309-004_bbbed9d2-b630-237f-e053-2995a90acd52
Type: HUMAN OTC DRUG
Nonproprietary name: Ethyl Alcohol
Dosage form: GEL
Route: TOPICAL
Labeler: LYW BIOTECH CO LIMITED GUANGZHOU
Application: part333A
Marketing category: OTC MONOGRAPH NOT FINAL
Marketing start: 2021-02-01
Marketing end: 0000-00-00
Substance: ALCOHOL
Active strength: 62 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	81309-004		I	Inactivated by FDA	2026-10-05
excluded package	package	81309-004	81309-004-01	I	Inactivated by FDA	2026-10-05
excluded package	package	81309-004	81309-004-02	I	Inactivated by FDA	2026-10-05
excluded package	package	81309-004	81309-004-03	I	Inactivated by FDA	2026-10-05
excluded package	package	81309-004	81309-004-04	I	Inactivated by FDA	2026-10-05
excluded package	package	81309-004	81309-004-05	I	Inactivated by FDA	2026-10-05
excluded package	package	81309-004	81309-004-06	I	Inactivated by FDA	2026-10-05
excluded package	package	81309-004	81309-004-07	I	Inactivated by FDA	2026-10-05
excluded package	package	81309-004	81309-004-08	I	Inactivated by FDA	2026-10-05
excluded package	package	81309-004	81309-004-09	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 package	package	81309-004-07	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	81309-004-03	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	81309-004-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	81309-004-06	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	81309-004-09	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	81309-004-02	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	81309-004-04	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	81309-004-08	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	81309-004-01	`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 package	package	81309-004-07	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	81309-004-03	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	81309-004-05	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	81309-004-06	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	81309-004-09	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	81309-004-02	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	81309-004-04	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	81309-004-08	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	81309-004-01	`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 package	package	81309-004-07	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	81309-004-03	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	81309-004-05	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	81309-004-06	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	81309-004-09	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	81309-004-02	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	81309-004-04	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	81309-004-08	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	81309-004-01	`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 package	package	81309-004-07	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	81309-004-03	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	81309-004-05	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	81309-004-06	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	81309-004-09	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	81309-004-02	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	81309-004-04	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	81309-004-08	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	81309-004-01	`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 package	package	81309-004-07	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	81309-004-03	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	81309-004-05	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	81309-004-06	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	81309-004-09	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	81309-004-02	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	81309-004-04	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	81309-004-08	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	81309-004-01	`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 package	package	81309-004-07	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	81309-004-03	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	81309-004-05	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	81309-004-06	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	81309-004-09	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	81309-004-02	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	81309-004-04	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	81309-004-08	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	81309-004-01	`cdf11ea48f46…`	`ba0047e9e063…`

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
81309-004-01	Hand Sanitizer
81309-004-02	Hand Sanitizer
81309-004-03	Hand Sanitizer
81309-004-04	Hand Sanitizer
81309-004-05	Hand Sanitizer
81309-004-06	Hand Sanitizer
81309-004-07	Hand Sanitizer
81309-004-08	Hand Sanitizer
81309-004-09	Hand Sanitizer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
81309-004-01	Hand Sanitizer	30 mL in 1 BOTTLE, PLASTIC	GEL	30	1
81309-004-02	Hand Sanitizer	60 mL in 1 BOTTLE, PLASTIC	GEL	60	1
81309-004-03	Hand Sanitizer	100 mL in 1 BOTTLE, PLASTIC	GEL	100	1
81309-004-04	Hand Sanitizer	120 mL in 1 BOTTLE, PLASTIC	GEL	120	1
81309-004-05	Hand Sanitizer	250 mL in 1 BOTTLE, PLASTIC	GEL	250	1
81309-004-06	Hand Sanitizer	500 mL in 1 BOTTLE, PLASTIC	GEL	500	1
81309-004-07	Hand Sanitizer	1000 mL in 1 BOTTLE, PLASTIC	GEL	1000	1
81309-004-08	Hand Sanitizer	1500 mL in 1 BOTTLE, PLASTIC	GEL	1500	1
81309-004-09	Hand Sanitizer	2000 mL in 1 BOTTLE, PLASTIC	GEL	2000	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
81309-004	HAND SANITIZER (ETHYL ALCOHOL) GEL [LYW BIOTECH CO LIMITED GUANGZHOU]	1	Legacy NDC, 9 package rows	20210222_bbbed9d2-b62f-237f-e053-2995a90acd52.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
581660	ethanol 62 % Topical Gel	PSN	bbbed9d2-b62f-237f-e053-2995a90acd52	1
581660	ethanol 0.62 ML/ML Topical Gel	SCD	bbbed9d2-b62f-237f-e053-2995a90acd52	1
581660	ethanol 62 % Topical Gel	SY	bbbed9d2-b62f-237f-e053-2995a90acd52	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
81309-004-01	81309000401	30 mL in 1 BOTTLE, PLASTIC (81309-004-01)	30 ml	2021-02-01	0000-00-00	No	No	Current
81309-004-02	81309000402	60 mL in 1 BOTTLE, PLASTIC (81309-004-02)	60 ml	2021-02-01	0000-00-00	No	No	Current
81309-004-03	81309000403	100 mL in 1 BOTTLE, PLASTIC (81309-004-03)	100 ml	2021-02-01	0000-00-00	No	No	Current
81309-004-04	81309000404	120 mL in 1 BOTTLE, PLASTIC (81309-004-04)	120 ml	2021-02-01	0000-00-00	No	No	Current
81309-004-05	81309000405	250 mL in 1 BOTTLE, PLASTIC (81309-004-05)	250 ml	2021-02-01	0000-00-00	No	No	Current
81309-004-06	81309000406	500 mL in 1 BOTTLE, PLASTIC (81309-004-06)	500 ml	2021-02-01	0000-00-00	No	No	Current
81309-004-07	81309000407	1000 mL in 1 BOTTLE, PLASTIC (81309-004-07)	1000 ml	2021-02-01	0000-00-00	No	No	Current
81309-004-08	81309000408	1500 mL in 1 BOTTLE, PLASTIC (81309-004-08)	1500 ml	2021-02-01	0000-00-00	No	No	Current
81309-004-09	81309000409	2000 mL in 1 BOTTLE, PLASTIC (81309-004-09)	2000 ml	2021-02-01	0000-00-00	No	No	Current