SIMIKA

Product NDC: 77598-123
11-digit product format: 775980123
Labeler code: 77598
Product ID: 77598-123_ab3396ad-8de5-2207-e053-2995a90a9e96
Type: HUMAN OTC DRUG
Nonproprietary name: Disinfection Gel
Dosage form: GEL
Route: TOPICAL
Labeler: Guangzhou Ouzhuang Biological Technology Co Ltd
Application: part333A
Marketing category: OTC MONOGRAPH NOT FINAL
Marketing start: 2020-05-15
Marketing end: 0000-00-00
Substance: ALCOHOL
Active strength: 73 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 · 14 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	77598-123		I	Inactivated by FDA	2026-10-05
excluded package	package	77598-123	77598-123-01	I	Inactivated by FDA	2026-10-05
excluded package	package	77598-123	77598-123-02	I	Inactivated by FDA	2026-10-05
excluded package	package	77598-123	77598-123-03	I	Inactivated by FDA	2026-10-05
excluded package	package	77598-123	77598-123-04	I	Inactivated by FDA	2026-10-05
excluded package	package	77598-123	77598-123-05	I	Inactivated by FDA	2026-10-05
excluded package	package	77598-123	77598-123-06	I	Inactivated by FDA	2026-10-05
excluded package	package	77598-123	77598-123-07	I	Inactivated by FDA	2026-10-05
excluded package	package	77598-123	77598-123-08	I	Inactivated by FDA	2026-10-05
excluded package	package	77598-123	77598-123-09	I	Inactivated by FDA	2026-10-05
excluded package	package	77598-123	77598-123-10	I	Inactivated by FDA	2026-10-05
excluded package	package	77598-123	77598-123-11	I	Inactivated by FDA	2026-10-05
excluded package	package	77598-123	77598-123-12	I	Inactivated by FDA	2026-10-05
excluded package	package	77598-123	77598-123-20	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 · 252 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	77598-123-01	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	77598-123-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	77598-123-07	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	77598-123-11	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	77598-123-04	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	77598-123-12	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	77598-123-10	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	77598-123-02	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	77598-123-09	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	77598-123-20	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	77598-123-06	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	77598-123-08	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	77598-123-03	`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	77598-123-01	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	77598-123-05	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	77598-123-07	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	77598-123-11	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	77598-123-04	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	77598-123-12	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	77598-123-10	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	77598-123-02	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	77598-123-09	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	77598-123-20	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	77598-123-06	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	77598-123-08	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	77598-123-03	`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	77598-123-01	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	77598-123-05	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	77598-123-07	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	77598-123-11	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	77598-123-04	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	77598-123-12	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	77598-123-10	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	77598-123-02	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	77598-123-09	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	77598-123-20	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	77598-123-06	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	77598-123-08	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	77598-123-03	`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	77598-123-01	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	77598-123-05	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	77598-123-07	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	77598-123-11	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	77598-123-04	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	77598-123-12	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	77598-123-10	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	77598-123-02	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	77598-123-09	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	77598-123-20	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	77598-123-06	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	77598-123-08	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	77598-123-03	`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	77598-123-01	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	77598-123-05	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	77598-123-07	`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
77598-123-01	Guangzhou-SIMIKA Gel
77598-123-02	Guangzhou-SIMIKA Gel
77598-123-03	Guangzhou-SIMIKA Gel
77598-123-04	Guangzhou-SIMIKA Gel
77598-123-05	Guangzhou-SIMIKA Gel
77598-123-06	Guangzhou-SIMIKA Gel
77598-123-07	Guangzhou-SIMIKA Gel
77598-123-08	Guangzhou-SIMIKA Gel
77598-123-09	Guangzhou-SIMIKA Gel
77598-123-10	Guangzhou-SIMIKA Gel
77598-123-11	Guangzhou-SIMIKA Gel
77598-123-12	Guangzhou-SIMIKA Gel
77598-123-20	Guangzhou-SIMIKA Gel

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
77598-123-01	SIMIKA	30 mL in 1 BOTTLE	GEL	30	2
77598-123-02	SIMIKA	50 mL in 1 BOTTLE	GEL	50	2
77598-123-03	SIMIKA	60 mL in 1 BOTTLE	GEL	60	2
77598-123-04	SIMIKA	80 mL in 1 BOTTLE	GEL	80	2
77598-123-05	SIMIKA	100 mL in 1 BOTTLE	GEL	100	2
77598-123-06	SIMIKA	200 mL in 1 BOTTLE	GEL	200	2
77598-123-07	SIMIKA	250 mL in 1 BOTTLE	GEL	250	2
77598-123-08	SIMIKA	300 mL in 1 BOTTLE	GEL	300	2
77598-123-09	SIMIKA	500 mL in 1 BOTTLE	GEL	500	2
77598-123-10	SIMIKA	1000 mL in 1 BOTTLE	GEL	1000	2
77598-123-11	SIMIKA	3000 mL in 1 BOTTLE	GEL	3000	2
77598-123-12	SIMIKA	5000 mL in 1 BOTTLE	GEL	5000	2
77598-123-20	SIMIKA	60 mL in 1 TUBE	GEL	60	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
77598-123	SIMIKA (DISINFECTION GEL) GEL [GUANGZHOU OUZHUANG BIOLOGICAL TECHNOLOGY CO LTD]	2	Legacy NDC, 13 package rows	20200725_a5c01c01-3727-1809-e053-2995a90a773a.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
2286987	ethanol 73 % Topical Gel	PSN	a5c01c01-3727-1809-e053-2995a90a773a	2
2286987	ethanol 0.73 ML/ML Topical Gel	SCD	a5c01c01-3727-1809-e053-2995a90a773a	2
2286987	ethanol 73 % Topical Gel	SY	a5c01c01-3727-1809-e053-2995a90a773a	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
77598-123-01	77598012301	30 mL in 1 BOTTLE (77598-123-01)	30 ml	2020-05-15	0000-00-00	No	No	Current
77598-123-02	77598012302	50 mL in 1 BOTTLE (77598-123-02)	50 ml	2020-05-15	0000-00-00	No	No	Current
77598-123-03	77598012303	60 mL in 1 BOTTLE (77598-123-03)	60 ml	2020-05-15	0000-00-00	No	No	Current
77598-123-04	77598012304	80 mL in 1 BOTTLE (77598-123-04)	80 ml	2020-05-15	0000-00-00	No	No	Current
77598-123-05	77598012305	100 mL in 1 BOTTLE (77598-123-05)	100 ml	2020-05-15	0000-00-00	No	No	Current
77598-123-06	77598012306	200 mL in 1 BOTTLE (77598-123-06)	200 ml	2020-05-15	0000-00-00	No	No	Current
77598-123-07	77598012307	250 mL in 1 BOTTLE (77598-123-07)	250 ml	2020-05-15	0000-00-00	No	No	Current
77598-123-08	77598012308	300 mL in 1 BOTTLE (77598-123-08)	300 ml	2020-05-15	0000-00-00	No	No	Current
77598-123-09	77598012309	500 mL in 1 BOTTLE (77598-123-09)	500 ml	2020-05-15	0000-00-00	No	No	Current
77598-123-10	77598012310	1000 mL in 1 BOTTLE (77598-123-10)	1000 ml	2020-05-15	0000-00-00	No	No	Current
77598-123-11	77598012311	3000 mL in 1 BOTTLE (77598-123-11)	3000 ml	2020-05-15	0000-00-00	No	No	Current
77598-123-12	77598012312	5000 mL in 1 BOTTLE (77598-123-12)	5000 ml	2020-05-15	0000-00-00	No	No	Current
77598-123-20	77598012320	60 mL in 1 TUBE (77598-123-20)	60 ml	2020-05-15	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Guangzhou-SIMIKA Gel	Guangzhou Ouzhuang Biological Technology Co Ltd	2020-07-24	HUMAN OTC DRUG LABEL	2