Hand Sanitizer

Product NDC: 78019-800
11-digit product format: 780190800
Labeler code: 78019
Product ID: 78019-800_ba65f0f4-baa4-62a2-e053-2995a90af449
Type: HUMAN OTC DRUG
Nonproprietary name: Ethyl Alcohol
Dosage form: GEL
Route: TOPICAL
Labeler: Wenzhou Shengkai Technology Industry Co., Ltd.
Application: part333E
Marketing category: OTC MONOGRAPH NOT FINAL
Marketing start: 2020-06-29
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 · 12 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	78019-800		I	Inactivated by FDA	2026-10-05
excluded package	package	78019-800	78019-800-01	I	Inactivated by FDA	2026-10-05
excluded package	package	78019-800	78019-800-02	I	Inactivated by FDA	2026-10-05
excluded package	package	78019-800	78019-800-03	I	Inactivated by FDA	2026-10-05
excluded package	package	78019-800	78019-800-04	I	Inactivated by FDA	2026-10-05
excluded package	package	78019-800	78019-800-05	I	Inactivated by FDA	2026-10-05
excluded package	package	78019-800	78019-800-06	I	Inactivated by FDA	2026-10-05
excluded package	package	78019-800	78019-800-07	I	Inactivated by FDA	2026-10-05
excluded package	package	78019-800	78019-800-08	I	Inactivated by FDA	2026-10-05
excluded package	package	78019-800	78019-800-09	I	Inactivated by FDA	2026-10-05
excluded package	package	78019-800	78019-800-10	I	Inactivated by FDA	2026-10-05
excluded package	package	78019-800	78019-800-11	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 · 180 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	78019-800-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	78019-800-07	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	78019-800-06	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	78019-800-11	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	78019-800-01	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	78019-800-09	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	78019-800-03	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	78019-800-02	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	78019-800-08	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	78019-800-10	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	78019-800-04	`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	78019-800-05	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	78019-800-07	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	78019-800-06	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	78019-800-11	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	78019-800-01	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	78019-800-09	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	78019-800-03	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	78019-800-02	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	78019-800-08	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	78019-800-10	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	78019-800-04	`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	78019-800-05	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	78019-800-07	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	78019-800-06	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	78019-800-11	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	78019-800-01	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	78019-800-09	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	78019-800-03	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	78019-800-02	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	78019-800-08	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	78019-800-10	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	78019-800-04	`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	78019-800-05	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	78019-800-07	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	78019-800-06	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	78019-800-11	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	78019-800-01	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	78019-800-09	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	78019-800-03	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	78019-800-02	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	78019-800-08	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	78019-800-10	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	78019-800-04	`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	78019-800-05	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	78019-800-07	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	78019-800-06	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	78019-800-11	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	78019-800-01	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	78019-800-09	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	78019-800-03	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	78019-800-02	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	78019-800-08	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	78019-800-10	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	78019-800-04	`cfe11265f3b6…`	`090c488252e2…`

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
78019-800-01	78019-800 75% Alcohol Hand Sanitizer
78019-800-02	78019-800 75% Alcohol Hand Sanitizer
78019-800-03	78019-800 75% Alcohol Hand Sanitizer
78019-800-04	78019-800 75% Alcohol Hand Sanitizer
78019-800-05	78019-800 75% Alcohol Hand Sanitizer
78019-800-06	78019-800 75% Alcohol Hand Sanitizer
78019-800-07	78019-800 75% Alcohol Hand Sanitizer
78019-800-08	78019-800 75% Alcohol Hand Sanitizer
78019-800-09	78019-800 75% Alcohol Hand Sanitizer
78019-800-10	78019-800 75% Alcohol Hand Sanitizer
78019-800-11	78019-800 75% Alcohol Hand Sanitizer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
78019-800-01	Hand Sanitizer	2 mL in 1 BAG	GEL	2	2
78019-800-02	Hand Sanitizer	3 mL in 1 BAG	GEL	3	2
78019-800-03	Hand Sanitizer	5 mL in 1 BAG	GEL	5	2
78019-800-04	Hand Sanitizer	10 mL in 1 BAG	GEL	10	2
78019-800-05	Hand Sanitizer	30 mL in 1 BOTTLE	GEL	30	2
78019-800-06	Hand Sanitizer	60 mL in 1 BOTTLE	GEL	60	2
78019-800-07	Hand Sanitizer	50 mL in 1 BOTTLE	GEL	50	2
78019-800-08	Hand Sanitizer	100 mL in 1 BOTTLE	GEL	100	2
78019-800-09	Hand Sanitizer	120 mL in 1 BOTTLE	GEL	120	2
78019-800-10	Hand Sanitizer	250 mL in 1 BOTTLE	GEL	250	2
78019-800-11	Hand Sanitizer	500 mL in 1 BOTTLE	GEL	500	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
78019-800	HAND SANITIZER (ETHYL ALCOHOL) GEL [WENZHOU SHENGKAI TECHNOLOGY INDUSTRY CO., LTD.]	2	Legacy NDC, 11 package rows	20210204_a92e93c1-5183-5fae-e053-2995a90ada20.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	a92e93c1-5183-5fae-e053-2995a90ada20	2
1305100	ethanol 0.75 ML/ML Topical Gel	SCD	a92e93c1-5183-5fae-e053-2995a90ada20	2
1305100	ethanol 75 % Topical Gel	SY	a92e93c1-5183-5fae-e053-2995a90ada20	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
78019-800-01	78019080001	2 mL in 1 BAG (78019-800-01)	2 ml	2020-06-29	0000-00-00	No	No	Current
78019-800-02	78019080002	3 mL in 1 BAG (78019-800-02)	3 ml	2020-06-29	0000-00-00	No	No	Current
78019-800-03	78019080003	5 mL in 1 BAG (78019-800-03)	5 ml	2020-06-29	0000-00-00	No	No	Current
78019-800-04	78019080004	10 mL in 1 BAG (78019-800-04)	10 ml	2020-06-29	0000-00-00	No	No	Current
78019-800-05	78019080005	30 mL in 1 BOTTLE (78019-800-05)	30 ml	2020-06-29	0000-00-00	No	No	Current
78019-800-06	78019080006	60 mL in 1 BOTTLE (78019-800-06)	60 ml	2020-06-29	0000-00-00	No	No	Current
78019-800-07	78019080007	50 mL in 1 BOTTLE (78019-800-07)	50 ml	2020-06-29	0000-00-00	No	No	Current
78019-800-08	78019080008	100 mL in 1 BOTTLE (78019-800-08)	100 ml	2020-06-29	0000-00-00	No	No	Current
78019-800-09	78019080009	120 mL in 1 BOTTLE (78019-800-09)	120 ml	2020-06-29	0000-00-00	No	No	Current
78019-800-10	78019080010	250 mL in 1 BOTTLE (78019-800-10)	250 ml	2020-06-29	0000-00-00	No	No	Current
78019-800-11	78019080011	500 mL in 1 BOTTLE (78019-800-11)	500 ml	2020-06-29	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
78019-800 75% Alcohol Hand Sanitizer	Wenzhou Shengkai Technology Industry Co., Ltd.	2021-02-02	HUMAN OTC DRUG LABEL	2