Hand Sanitizer

Product NDC: 77607-100
11-digit product format: 776070100
Labeler code: 77607
Product ID: 77607-100_a61881f7-832f-b943-e053-2995a90a883c
Type: HUMAN OTC DRUG
Nonproprietary name: Hand Sanitizer
Dosage form: GEL
Route: TOPICAL
Labeler: Xiamen Afgamarine Biotechnology Co., Ltd.
Application: part333A
Marketing category: OTC MONOGRAPH NOT FINAL
Marketing start: 2020-05-19
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	77607-100		I	Inactivated by FDA	2026-10-05
excluded package	package	77607-100	77607-100-01	I	Inactivated by FDA	2026-10-05
excluded package	package	77607-100	77607-100-03	I	Inactivated by FDA	2026-10-05
excluded package	package	77607-100	77607-100-05	I	Inactivated by FDA	2026-10-05
excluded package	package	77607-100	77607-100-08	I	Inactivated by FDA	2026-10-05
excluded package	package	77607-100	77607-100-09	I	Inactivated by FDA	2026-10-05
excluded package	package	77607-100	77607-100-12	I	Inactivated by FDA	2026-10-05
excluded package	package	77607-100	77607-100-15	I	Inactivated by FDA	2026-10-05
excluded package	package	77607-100	77607-100-19	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 · 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	77607-100-03	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	77607-100-09	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	77607-100-08	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	77607-100-12	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	77607-100-01	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	77607-100-15	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	77607-100-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	77607-100-19	`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	77607-100-03	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	77607-100-09	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	77607-100-08	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	77607-100-12	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	77607-100-01	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	77607-100-15	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	77607-100-05	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	77607-100-19	`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	77607-100-03	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	77607-100-09	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	77607-100-08	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	77607-100-12	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	77607-100-01	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	77607-100-15	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	77607-100-05	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	77607-100-19	`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	77607-100-03	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	77607-100-09	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	77607-100-08	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	77607-100-12	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	77607-100-01	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	77607-100-15	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	77607-100-05	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	77607-100-19	`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	77607-100-03	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	77607-100-09	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	77607-100-08	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	77607-100-12	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	77607-100-01	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	77607-100-15	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	77607-100-05	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	77607-100-19	`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	77607-100-03	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	77607-100-09	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	77607-100-08	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	77607-100-12	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	77607-100-01	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	77607-100-15	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	77607-100-05	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	77607-100-19	`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	77607-100-03	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	77607-100-09	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	77607-100-08	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	77607-100-12	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	77607-100-01	`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
77607-100-01	Afgamarine, Hand Sanitizer, Ethanol 75%, Gel
77607-100-03	Afgamarine, Hand Sanitizer, Ethanol 75%, Gel
77607-100-05	Afgamarine, Hand Sanitizer, Ethanol 75%, Gel
77607-100-08	Afgamarine, Hand Sanitizer, Ethanol 75%, Gel
77607-100-09	Afgamarine, Hand Sanitizer, Ethanol 75%, Gel
77607-100-12	Afgamarine, Hand Sanitizer, Ethanol 75%, Gel
77607-100-15	Afgamarine, Hand Sanitizer, Ethanol 75%, Gel
77607-100-19	Afgamarine, Hand Sanitizer, Ethanol 75%, Gel

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
77607-100-01	Hand Sanitizer	30 mL in 1 BOTTLE	GEL	30	1
77607-100-03	Hand Sanitizer	60 mL in 1 BOTTLE	GEL	60	1
77607-100-05	Hand Sanitizer	100 mL in 1 BOTTLE	GEL	100	1
77607-100-08	Hand Sanitizer	200 mL in 1 BOTTLE	GEL	200	1
77607-100-09	Hand Sanitizer	236 mL in 1 BOTTLE	GEL	236	1
77607-100-12	Hand Sanitizer	300 mL in 1 BOTTLE	GEL	300	1
77607-100-15	Hand Sanitizer	500 mL in 1 BOTTLE	GEL	500	1
77607-100-19	Hand Sanitizer	946 mL in 1 BOTTLE	GEL	946	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
77607-100	HAND SANITIZER GEL [XIAMEN AFGAMARINE BIOTECHNOLOGY CO., LTD.]	1	Legacy NDC, 8 package rows	20200521_a61881f7-832e-b943-e053-2995a90a883c.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	a61881f7-832e-b943-e053-2995a90a883c	1
1305100	ethanol 0.75 ML/ML Topical Gel	SCD	a61881f7-832e-b943-e053-2995a90a883c	1
1305100	ethanol 75 % Topical Gel	SY	a61881f7-832e-b943-e053-2995a90a883c	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
77607-100-01	77607010001	30 mL in 1 BOTTLE (77607-100-01)	30 ml	2020-05-19	0000-00-00	No	No	Current
77607-100-03	77607010003	60 mL in 1 BOTTLE (77607-100-03)	60 ml	2020-05-19	0000-00-00	No	No	Current
77607-100-05	77607010005	100 mL in 1 BOTTLE (77607-100-05)	100 ml	2020-05-19	0000-00-00	No	No	Current
77607-100-08	77607010008	200 mL in 1 BOTTLE (77607-100-08)	200 ml	2020-05-19	0000-00-00	Yes	No	Current
77607-100-09	77607010009	236 mL in 1 BOTTLE (77607-100-09)	236 ml	2020-05-19	0000-00-00	No	No	Current
77607-100-12	77607010012	300 mL in 1 BOTTLE (77607-100-12)	300 ml	2020-05-19	0000-00-00	No	No	Current
77607-100-15	77607010015	500 mL in 1 BOTTLE (77607-100-15)	500 ml	2020-05-19	0000-00-00	No	No	Current
77607-100-19	77607010019	946 mL in 1 BOTTLE (77607-100-19)	946 ml	2020-05-19	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Afgamarine, Hand Sanitizer, Ethanol 75%, Gel	Xiamen Afgamarine Biotechnology Co., Ltd. \| A03 Lab of BTS	2020-05-20	HUMAN OTC DRUG LABEL	1