SHIERJIE 75% Alcohol rinse free hand sanitizer

Product NDC: 43116-002
11-digit product format: 431160002
Labeler code: 43116
Product ID: 43116-002_b4bdbcfb-5515-5c5a-e053-2995a90abf7e
Type: HUMAN OTC DRUG
Nonproprietary name: SHIERJIE 75% Alcohol rinse free hand sanitizer
Dosage form: LIQUID
Route: TOPICAL
Labeler: Shenzhen Shierjie Biological Engineering Co., LTD
Application: part333A
Marketing category: OTC MONOGRAPH NOT FINAL
Marketing start: 2020-03-31
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 · 8 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	43116-002		I	Inactivated by FDA	2026-10-12
excluded package	package	43116-002	43116-002-01	I	Inactivated by FDA	2026-10-12
excluded package	package	43116-002	43116-002-02	I	Inactivated by FDA	2026-10-12
excluded package	package	43116-002	43116-002-03	I	Inactivated by FDA	2026-10-12
excluded package	package	43116-002	43116-002-04	I	Inactivated by FDA	2026-10-12
excluded package	package	43116-002	43116-002-05	I	Inactivated by FDA	2026-10-12
excluded package	package	43116-002	43116-002-06	I	Inactivated by FDA	2026-10-12
excluded package	package	43116-002	43116-002-07	I	Inactivated by FDA	2026-10-12

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 · 144 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	43116-002-07	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	43116-002-01	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	43116-002-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	43116-002-06	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	43116-002-03	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	43116-002-04	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	43116-002-02	`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	43116-002-07	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	43116-002-01	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	43116-002-05	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	43116-002-06	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	43116-002-03	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	43116-002-04	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	43116-002-02	`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	43116-002-07	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	43116-002-01	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	43116-002-05	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	43116-002-06	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	43116-002-03	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	43116-002-04	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	43116-002-02	`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	43116-002-07	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	43116-002-01	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	43116-002-05	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	43116-002-06	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	43116-002-03	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	43116-002-04	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	43116-002-02	`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	43116-002-07	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	43116-002-01	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	43116-002-05	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	43116-002-06	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	43116-002-03	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	43116-002-04	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	43116-002-02	`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	43116-002-07	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	43116-002-01	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	43116-002-05	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	43116-002-06	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	43116-002-03	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	43116-002-04	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	43116-002-02	`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	43116-002-07	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	43116-002-01	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	43116-002-05	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	43116-002-06	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	43116-002-03	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	43116-002-04	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	43116-002-02	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	43116-002-07	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	43116-002-01	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	43116-002-05	`ed331223b511…`	`672a5bd82f5f…`

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
43116-002-01	43116-002 SHIERJIE 75% Alcohol rinse free hand sanitizer
43116-002-02	43116-002 SHIERJIE 75% Alcohol rinse free hand sanitizer
43116-002-03	43116-002 SHIERJIE 75% Alcohol rinse free hand sanitizer
43116-002-04	43116-002 SHIERJIE 75% Alcohol rinse free hand sanitizer
43116-002-05	43116-002 SHIERJIE 75% Alcohol rinse free hand sanitizer
43116-002-06	43116-002 SHIERJIE 75% Alcohol rinse free hand sanitizer
43116-002-07	43116-002 SHIERJIE 75% Alcohol rinse free hand sanitizer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
43116-002-01	SHIERJIE 75% Alcohol rinse free hand sanitizer	60 mL in 1 BOTTLE	LIQUID	60	4
43116-002-02	SHIERJIE 75% Alcohol rinse free hand sanitizer	100 mL in 1 BOTTLE	LIQUID	100	4
43116-002-03	SHIERJIE 75% Alcohol rinse free hand sanitizer	120 mL in 1 BOTTLE	LIQUID	120	4
43116-002-04	SHIERJIE 75% Alcohol rinse free hand sanitizer	240 mL in 1 BOTTLE	LIQUID	240	4
43116-002-05	SHIERJIE 75% Alcohol rinse free hand sanitizer	300 mL in 1 BOTTLE	LIQUID	300	4
43116-002-06	SHIERJIE 75% Alcohol rinse free hand sanitizer	500 mL in 1 BOTTLE	LIQUID	500	4
43116-002-07	SHIERJIE 75% Alcohol rinse free hand sanitizer	4900 mL in 1 BOTTLE	LIQUID	4900	4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
43116-002	SHIERJIE 75% ALCOHOL RINSE FREE HAND SANITIZER LIQUID [SHENZHEN SHIERJIE BIOLOGICAL ENGINEERING CO., LTD]	4	Legacy NDC, 7 package rows	20201123_a223b5c4-8943-05bd-e053-2a95a90a78e1.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	a223b5c4-8943-05bd-e053-2a95a90a78e1	4
1305100	ethanol 0.75 ML/ML Topical Gel	SCD	a223b5c4-8943-05bd-e053-2a95a90a78e1	4
1305100	ethanol 75 % Topical Gel	SY	a223b5c4-8943-05bd-e053-2a95a90a78e1	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
43116-002-01	43116000201	60 mL in 1 BOTTLE (43116-002-01)	60 ml	2020-03-31	0000-00-00	No	No	Current
43116-002-02	43116000202	100 mL in 1 BOTTLE (43116-002-02)	100 ml	2020-03-31	0000-00-00	No	No	Current
43116-002-03	43116000203	120 mL in 1 BOTTLE (43116-002-03)	120 ml	2020-03-31	0000-00-00	No	No	Current
43116-002-04	43116000204	240 mL in 1 BOTTLE (43116-002-04)	240 ml	2020-03-31	0000-00-00	No	No	Current
43116-002-05	43116000205	300 mL in 1 BOTTLE (43116-002-05)	300 ml	2020-03-31	0000-00-00	No	No	Current
43116-002-06	43116000206	500 mL in 1 BOTTLE (43116-002-06)	500 ml	2020-03-31	0000-00-00	No	No	Current
43116-002-07	43116000207	4900 mL in 1 BOTTLE (43116-002-07)	4900 ml	2020-03-31	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
43116-002 SHIERJIE 75% Alcohol rinse free hand sanitizer	Shenzhen Shierjie Biological Engineering Co., LTD	2020-11-22	HUMAN OTC DRUG LABEL	4