Hand Sanitizer

Product NDC: 77753-004
11-digit product format: 777530004
Labeler code: 77753
Product ID: 77753-004_a7b22505-52d9-47fd-e053-2995a90a77b3
Type: HUMAN OTC DRUG
Nonproprietary name: Ethyl Alcohol
Dosage form: GEL
Route: TOPICAL
Labeler: SHANDISHI Biological Technology Co., Ltd.
Application: part333E
Marketing category: OTC MONOGRAPH NOT FINAL
Marketing start: 2020-05-08
Marketing end: 0000-00-00
Substance: ALCOHOL
Active strength: 70 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 · 15 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	77753-004		I	Inactivated by FDA	2026-10-05
excluded package	package	77753-004	77753-004-01	I	Inactivated by FDA	2026-10-05
excluded package	package	77753-004	77753-004-02	I	Inactivated by FDA	2026-10-05
excluded package	package	77753-004	77753-004-03	I	Inactivated by FDA	2026-10-05
excluded package	package	77753-004	77753-004-04	I	Inactivated by FDA	2026-10-05
excluded package	package	77753-004	77753-004-05	I	Inactivated by FDA	2026-10-05
excluded package	package	77753-004	77753-004-06	I	Inactivated by FDA	2026-10-05
excluded package	package	77753-004	77753-004-07	I	Inactivated by FDA	2026-10-05
excluded package	package	77753-004	77753-004-08	I	Inactivated by FDA	2026-10-05
excluded package	package	77753-004	77753-004-09	I	Inactivated by FDA	2026-10-05
excluded package	package	77753-004	77753-004-10	I	Inactivated by FDA	2026-10-05
excluded package	package	77753-004	77753-004-11	I	Inactivated by FDA	2026-10-05
excluded package	package	77753-004	77753-004-12	I	Inactivated by FDA	2026-10-05
excluded package	package	77753-004	77753-004-13	I	Inactivated by FDA	2026-10-05
excluded package	package	77753-004	77753-004-14	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 5 · 270 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	77753-004-12	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	77753-004-06	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	77753-004-04	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	77753-004-13	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	77753-004-02	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	77753-004-09	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	77753-004-03	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	77753-004-11	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	77753-004-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	77753-004-14	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	77753-004-01	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	77753-004-08	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	77753-004-07	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	77753-004-10	`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	77753-004-12	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	77753-004-06	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	77753-004-04	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	77753-004-13	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	77753-004-02	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	77753-004-09	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	77753-004-03	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	77753-004-11	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	77753-004-05	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	77753-004-14	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	77753-004-01	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	77753-004-08	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	77753-004-07	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	77753-004-10	`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	77753-004-12	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	77753-004-06	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	77753-004-04	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	77753-004-13	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	77753-004-02	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	77753-004-09	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	77753-004-03	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	77753-004-11	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	77753-004-05	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	77753-004-14	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	77753-004-01	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	77753-004-08	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	77753-004-07	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	77753-004-10	`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	77753-004-12	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	77753-004-06	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	77753-004-04	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	77753-004-13	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	77753-004-02	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	77753-004-09	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	77753-004-03	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	77753-004-11	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	77753-004-05	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	77753-004-14	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	77753-004-01	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	77753-004-08	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	77753-004-07	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	77753-004-10	`a1b67e2a42f9…`	`c4cf2c586c0d…`

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
77753-004-01	77753-004 Hand Sanitizer 70% Alcohol
77753-004-02	77753-004 Hand Sanitizer 70% Alcohol
77753-004-03	77753-004 Hand Sanitizer 70% Alcohol
77753-004-04	77753-004 Hand Sanitizer 70% Alcohol
77753-004-05	77753-004 Hand Sanitizer 70% Alcohol
77753-004-06	77753-004 Hand Sanitizer 70% Alcohol
77753-004-07	77753-004 Hand Sanitizer 70% Alcohol
77753-004-08	77753-004 Hand Sanitizer 70% Alcohol
77753-004-09	77753-004 Hand Sanitizer 70% Alcohol
77753-004-10	77753-004 Hand Sanitizer 70% Alcohol
77753-004-11	77753-004 Hand Sanitizer 70% Alcohol
77753-004-12	77753-004 Hand Sanitizer 70% Alcohol
77753-004-13	77753-004 Hand Sanitizer 70% Alcohol
77753-004-14	77753-004 Hand Sanitizer 70% Alcohol

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
77753-004-01	Hand Sanitizer	12 in 1 BOX	GEL	12	1
77753-004-01	Hand Sanitizer	10 mL in 1 BOTTLE	GEL	10	1
77753-004-02	Hand Sanitizer	15 mL in 1 BOTTLE	GEL	15	1
77753-004-02	Hand Sanitizer	12 in 1 BOX	GEL	12	1
77753-004-03	Hand Sanitizer	30 mL in 1 BOTTLE	GEL	30	1
77753-004-03	Hand Sanitizer	12 in 1 BOX	GEL	12	1
77753-004-04	Hand Sanitizer	53 mL in 1 BOTTLE	GEL	53	1
77753-004-04	Hand Sanitizer	12 in 1 BOX	GEL	12	1
77753-004-05	Hand Sanitizer	60 mL in 1 BOTTLE	GEL	60	1
77753-004-05	Hand Sanitizer	12 in 1 BAG	GEL	12	1
77753-004-06	Hand Sanitizer	120 mL in 1 BOTTLE	GEL	120	1
77753-004-06	Hand Sanitizer	8 in 1 BOX	GEL	8	1
77753-004-07	Hand Sanitizer	8 in 1 BOX	GEL	8	1
77753-004-07	Hand Sanitizer	236 mL in 1 BOTTLE	GEL	236	1
77753-004-08	Hand Sanitizer	8 in 1 BOX	GEL	8	1
77753-004-08	Hand Sanitizer	250 mL in 1 BOTTLE	GEL	250	1
77753-004-09	Hand Sanitizer	4 in 1 BOX	GEL	4	1
77753-004-09	Hand Sanitizer	473 mL in 1 BOTTLE	GEL	473	1
77753-004-10	Hand Sanitizer	4 in 1 BOX	GEL	4	1
77753-004-10	Hand Sanitizer	500 mL in 1 BOTTLE	GEL	500	1
77753-004-11	Hand Sanitizer	120 mL in 1 BOTTLE	GEL	120	1
77753-004-11	Hand Sanitizer	12 in 1 BOX	GEL	12	1
77753-004-12	Hand Sanitizer	4 in 1 BOX	GEL	4	1
77753-004-12	Hand Sanitizer	1000 mL in 1 BOTTLE	GEL	1000	1
77753-004-13	Hand Sanitizer	4 in 1 BOX	GEL	4	1
77753-004-13	Hand Sanitizer	2000 mL in 1 BOTTLE	GEL	2000	1
77753-004-14	Hand Sanitizer	4 in 1 BOX	GEL	4	1
77753-004-14	Hand Sanitizer	3780 mL in 1 BOTTLE	GEL	3780	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
77753-004	HAND SANITIZER (ETHYL ALCOHOL) GEL [SHANDISHI BIOLOGICAL TECHNOLOGY CO., LTD.]	1	Legacy NDC, 28 package rows	20200610_a7b1c019-b5a8-ca9d-e053-2a95a90a7724.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
581662	ethanol 70 % Topical Gel	PSN	a7b1c019-b5a8-ca9d-e053-2a95a90a7724	1
581662	ethanol 0.7 ML/ML Topical Gel	SCD	a7b1c019-b5a8-ca9d-e053-2a95a90a7724	1
581662	ethanol 70 % Topical Gel	SY	a7b1c019-b5a8-ca9d-e053-2a95a90a7724	1
581662	ethyl alcohol 70 % Topical Gel	SY	a7b1c019-b5a8-ca9d-e053-2a95a90a7724	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
77753-004-01	77753000401	12 BOTTLE in 1 BOX (77753-004-01) > 10 mL in 1 BOTTLE	12 bottle	2020-05-20	0000-00-00	No	No	Current
77753-004-02	77753000402	12 BOTTLE in 1 BOX (77753-004-02) > 15 mL in 1 BOTTLE	12 bottle	2020-05-09	0000-00-00	No	No	Current
77753-004-03	77753000403	12 BOTTLE in 1 BOX (77753-004-03) > 30 mL in 1 BOTTLE	12 bottle	2020-05-20	0000-00-00	No	No	Current
77753-004-04	77753000404	12 BOTTLE in 1 BOX (77753-004-04) > 53 mL in 1 BOTTLE	12 bottle	2020-05-09	0000-00-00	No	No	Current
77753-004-05	77753000405	12 BOTTLE in 1 BAG (77753-004-05) > 60 mL in 1 BOTTLE	12 bottle	2020-05-20	0000-00-00	No	No	Current
77753-004-06	77753000406	8 BOTTLE in 1 BOX (77753-004-06) > 120 mL in 1 BOTTLE	8 bottle	2020-05-20	0000-00-00	No	No	Current
77753-004-07	77753000407	8 BOTTLE in 1 BOX (77753-004-07) > 236 mL in 1 BOTTLE	8 bottle	2020-05-09	0000-00-00	No	No	Current
77753-004-08	77753000408	8 BOTTLE in 1 BOX (77753-004-08) > 250 mL in 1 BOTTLE	8 bottle	2020-05-20	0000-00-00	No	No	Current
77753-004-09	77753000409	4 BOTTLE in 1 BOX (77753-004-09) > 473 mL in 1 BOTTLE	4 bottle	2020-05-20	0000-00-00	No	No	Current
77753-004-10	77753000410	4 BOTTLE in 1 BOX (77753-004-10) > 500 mL in 1 BOTTLE	4 bottle	2020-05-20	0000-00-00	No	No	Current
77753-004-11	77753000411	12 BOTTLE in 1 BOX (77753-004-11) > 120 mL in 1 BOTTLE	12 bottle	2020-05-20	0000-00-00	No	No	Current
77753-004-12	77753000412	4 BOTTLE in 1 BOX (77753-004-12) > 1000 mL in 1 BOTTLE	4 bottle	2020-05-20	0000-00-00	No	No	Current
77753-004-13	77753000413	4 BOTTLE in 1 BOX (77753-004-13) > 2000 mL in 1 BOTTLE	4 bottle	2020-05-20	0000-00-00	No	No	Current
77753-004-14	77753000414	4 BOTTLE in 1 BOX (77753-004-14) > 3780 mL in 1 BOTTLE	4 bottle	2020-05-20	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
77753-004 Hand Sanitizer 70% Alcohol	SHANDISHI Biological Technology Co., Ltd.	2020-06-09	HUMAN OTC DRUG LABEL	1