Hand Sanitizer

Product NDC: 78351-001
11-digit product format: 783510001
Labeler code: 78351
Product ID: 78351-001_a64e4f9b-2d07-e113-e053-2995a90aa7d5
Type: HUMAN OTC DRUG
Nonproprietary name: Hand Sanitizer
Dosage form: GEL
Route: TOPICAL
Labeler: Sanlingyi(Guangdong)Medical Biotechnology Co.,Ltd.
Application: part333A
Marketing category: OTC MONOGRAPH NOT FINAL
Marketing start: 2020-05-18
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 · 15 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	78351-001		I	Inactivated by FDA	2026-08-17
excluded package	package	78351-001	78351-001-01	I	Inactivated by FDA	2026-08-17
excluded package	package	78351-001	78351-001-02	I	Inactivated by FDA	2026-08-17
excluded package	package	78351-001	78351-001-03	I	Inactivated by FDA	2026-08-17
excluded package	package	78351-001	78351-001-04	I	Inactivated by FDA	2026-08-17
excluded package	package	78351-001	78351-001-05	I	Inactivated by FDA	2026-08-17
excluded package	package	78351-001	78351-001-06	I	Inactivated by FDA	2026-08-17
excluded package	package	78351-001	78351-001-07	I	Inactivated by FDA	2026-08-17
excluded package	package	78351-001	78351-001-08	I	Inactivated by FDA	2026-08-17
excluded package	package	78351-001	78351-001-09	I	Inactivated by FDA	2026-08-17
excluded package	package	78351-001	78351-001-10	I	Inactivated by FDA	2026-08-17
excluded package	package	78351-001	78351-001-11	I	Inactivated by FDA	2026-08-17
excluded package	package	78351-001	78351-001-12	I	Inactivated by FDA	2026-08-17
excluded package	package	78351-001	78351-001-13	I	Inactivated by FDA	2026-08-17
excluded package	package	78351-001	78351-001-14	I	Inactivated by FDA	2026-08-17

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 · 285 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	78351-001-06	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	78351-001-10	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	78351-001-09	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	78351-001-02	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	78351-001-14	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	78351-001-01	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	78351-001-13	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	78351-001-04	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	78351-001-03	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	78351-001-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	78351-001-11	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	78351-001-12	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	78351-001-07	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	78351-001-08	`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	78351-001-06	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	78351-001-10	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	78351-001-09	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	78351-001-02	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	78351-001-14	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	78351-001-01	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	78351-001-13	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	78351-001-04	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	78351-001-03	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	78351-001-05	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	78351-001-11	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	78351-001-12	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	78351-001-07	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	78351-001-08	`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	78351-001-06	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	78351-001-10	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	78351-001-09	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	78351-001-02	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	78351-001-14	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	78351-001-01	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	78351-001-13	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	78351-001-04	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	78351-001-03	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	78351-001-05	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	78351-001-11	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	78351-001-12	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	78351-001-07	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	78351-001-08	`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	78351-001-06	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	78351-001-10	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	78351-001-09	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	78351-001-02	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	78351-001-14	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	78351-001-01	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	78351-001-13	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	78351-001-04	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	78351-001-03	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	78351-001-05	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	78351-001-11	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	78351-001-12	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	78351-001-07	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	78351-001-08	`a1b67e2a42f9…`	`c4cf2c586c0d…`

FDA-Initiated Inactive NDC Indexing#

NDC, Related label table
NDC	Related label
78351-001-01	Hand Sanitizer GEL
78351-001-02	Hand Sanitizer GEL
78351-001-03	Hand Sanitizer GEL
78351-001-04	Hand Sanitizer GEL
78351-001-05	Hand Sanitizer GEL
78351-001-06	Hand Sanitizer GEL
78351-001-07	Hand Sanitizer GEL
78351-001-08	Hand Sanitizer GEL
78351-001-09	Hand Sanitizer GEL
78351-001-10	Hand Sanitizer GEL
78351-001-11	Hand Sanitizer GEL
78351-001-12	Hand Sanitizer GEL
78351-001-13	Hand Sanitizer GEL
78351-001-14	Hand Sanitizer GEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
78351-001-01	Hand Sanitizer	3 mL in 1 BOTTLE	GEL	3	1
78351-001-02	Hand Sanitizer	30 mL in 1 BOTTLE	GEL	30	1
78351-001-03	Hand Sanitizer	50 mL in 1 BOTTLE	GEL	50	1
78351-001-04	Hand Sanitizer	60 mL in 1 BOTTLE	GEL	60	1
78351-001-05	Hand Sanitizer	100 mL in 1 BOTTLE	GEL	100	1
78351-001-06	Hand Sanitizer	250 mL in 1 BOTTLE	GEL	250	1
78351-001-07	Hand Sanitizer	275 mL in 1 BOTTLE	GEL	275	1
78351-001-08	Hand Sanitizer	300 mL in 1 BOTTLE	GEL	300	1
78351-001-09	Hand Sanitizer	375 mL in 1 BOTTLE	GEL	375	1
78351-001-10	Hand Sanitizer	500 mL in 1 BOTTLE	GEL	500	1
78351-001-11	Hand Sanitizer	580 mL in 1 BOTTLE	GEL	580	1
78351-001-12	Hand Sanitizer	1000 mL in 1 BOTTLE	GEL	1000	1
78351-001-13	Hand Sanitizer	2000 mL in 1 BOTTLE	GEL	2000	1
78351-001-14	Hand Sanitizer	5000000 mL in 1 BOTTLE	GEL	5000000	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
78351-001	HAND SANITIZER GEL [SANLINGYI(GUANGDONG)MEDICAL BIOTECHNOLOGY CO.,LTD.]	1	Legacy NDC, 14 package rows	20200523_a64e4f9b-2d06-e113-e053-2995a90aa7d5.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	a64e4f9b-2d06-e113-e053-2995a90aa7d5	1
1305100	ethanol 0.75 ML/ML Topical Gel	SCD	a64e4f9b-2d06-e113-e053-2995a90aa7d5	1
1305100	ethanol 75 % Topical Gel	SY	a64e4f9b-2d06-e113-e053-2995a90aa7d5	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
78351-001-01	78351000101	3 mL in 1 BOTTLE (78351-001-01)	3 ml	2020-05-18	0000-00-00	No	No	Current
78351-001-02	78351000102	30 mL in 1 BOTTLE (78351-001-02)	30 ml	2020-05-18	0000-00-00	No	No	Current
78351-001-03	78351000103	50 mL in 1 BOTTLE (78351-001-03)	50 ml	2020-05-18	0000-00-00	No	No	Current
78351-001-04	78351000104	60 mL in 1 BOTTLE (78351-001-04)	60 ml	2020-05-18	0000-00-00	No	No	Current
78351-001-05	78351000105	100 mL in 1 BOTTLE (78351-001-05)	100 ml	2020-05-18	0000-00-00	No	No	Current
78351-001-06	78351000106	250 mL in 1 BOTTLE (78351-001-06)	250 ml	2020-05-18	0000-00-00	No	No	Current
78351-001-07	78351000107	275 mL in 1 BOTTLE (78351-001-07)	275 ml	2020-05-18	0000-00-00	No	No	Current
78351-001-08	78351000108	300 mL in 1 BOTTLE (78351-001-08)	300 ml	2020-05-18	0000-00-00	No	No	Current
78351-001-09	78351000109	375 mL in 1 BOTTLE (78351-001-09)	375 ml	2020-05-18	0000-00-00	No	No	Current
78351-001-10	78351000110	500 mL in 1 BOTTLE (78351-001-10)	500 ml	2020-05-18	0000-00-00	No	No	Current
78351-001-11	78351000111	580 mL in 1 BOTTLE (78351-001-11)	580 ml	2020-05-18	0000-00-00	No	No	Current
78351-001-12	78351000112	1000 mL in 1 BOTTLE (78351-001-12)	1000 ml	2020-05-18	0000-00-00	No	No	Current
78351-001-13	78351000113	2000 mL in 1 BOTTLE (78351-001-13)	2000 ml	2020-05-18	0000-00-00	No	No	Current
78351-001-14	78351000114	5000000 mL in 1 BOTTLE (78351-001-14)	5000000 ml	2020-05-18	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Hand Sanitizer GEL	Sanlingyi(Guangdong)Medical Biotechnology Co.,Ltd.	2020-05-17	HUMAN OTC DRUG LABEL	1