X PROUSA Antiseptic Hand Sanitizer Gel

Product NDC: 79490-000
11-digit product format: 794900000
Labeler code: 79490
Product ID: 79490-000_adcd85dc-829d-1e57-e053-2995a90ac799
Type: HUMAN OTC DRUG
Nonproprietary name: ALCOHOL
Dosage form: GEL
Route: TOPICAL
Labeler: X-PROUSA LLC
Application: part333E
Marketing category: OTC MONOGRAPH NOT FINAL
Marketing start: 2020-06-21
Marketing end: 0000-00-00
Substance: ALCOHOL
Active strength: 1 mL/mL
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	79490-000		I	Inactivated by FDA	2026-10-05
excluded package	package	79490-000	79490-000-01	I	Inactivated by FDA	2026-10-05
excluded package	package	79490-000	79490-000-02	I	Inactivated by FDA	2026-10-05
excluded package	package	79490-000	79490-000-04	I	Inactivated by FDA	2026-10-05
excluded package	package	79490-000	79490-000-08	I	Inactivated by FDA	2026-10-05
excluded package	package	79490-000	79490-000-16	I	Inactivated by FDA	2026-10-05
excluded package	package	79490-000	79490-000-32	I	Inactivated by FDA	2026-10-05
excluded package	package	79490-000	79490-000-38	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 · 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	79490-000-04	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	79490-000-32	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	79490-000-08	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	79490-000-02	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	79490-000-01	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	79490-000-16	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	79490-000-38	`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	79490-000-04	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	79490-000-32	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	79490-000-08	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	79490-000-02	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	79490-000-01	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	79490-000-16	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	79490-000-38	`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	79490-000-04	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	79490-000-32	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	79490-000-08	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	79490-000-02	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	79490-000-01	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	79490-000-16	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	79490-000-38	`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	79490-000-04	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	79490-000-32	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	79490-000-08	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	79490-000-02	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	79490-000-01	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	79490-000-16	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	79490-000-38	`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	79490-000-04	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	79490-000-32	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	79490-000-08	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	79490-000-02	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	79490-000-01	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	79490-000-16	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	79490-000-38	`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	79490-000-04	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	79490-000-32	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	79490-000-08	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	79490-000-02	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	79490-000-01	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	79490-000-16	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	79490-000-38	`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	79490-000-04	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	79490-000-32	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	79490-000-08	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	79490-000-02	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	79490-000-01	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	79490-000-16	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	79490-000-38	`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	79490-000-04	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	79490-000-32	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	79490-000-08	`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
79490-000-01	X-PROUSA Antiseptic Hand Sanitizer Gel
79490-000-02	X-PROUSA Antiseptic Hand Sanitizer Gel
79490-000-04	X-PROUSA Antiseptic Hand Sanitizer Gel
79490-000-08	X-PROUSA Antiseptic Hand Sanitizer Gel
79490-000-16	X-PROUSA Antiseptic Hand Sanitizer Gel
79490-000-32	X-PROUSA Antiseptic Hand Sanitizer Gel
79490-000-38	X-PROUSA Antiseptic Hand Sanitizer Gel

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
79490-000-01	X PROUSA Antiseptic Hand Sanitizer Gel	30 mL in 1 BOTTLE	GEL	30	2
79490-000-02	X PROUSA Antiseptic Hand Sanitizer Gel	60 mL in 1 BOTTLE	GEL	60	2
79490-000-04	X PROUSA Antiseptic Hand Sanitizer Gel	118 mL in 1 BOTTLE	GEL	118	2
79490-000-08	X PROUSA Antiseptic Hand Sanitizer Gel	240 mL in 1 BOTTLE	GEL	240	2
79490-000-16	X PROUSA Antiseptic Hand Sanitizer Gel	470 mL in 1 BOTTLE	GEL	470	2
79490-000-32	X PROUSA Antiseptic Hand Sanitizer Gel	950 mL in 1 BOTTLE	GEL	950	2
79490-000-38	X PROUSA Antiseptic Hand Sanitizer Gel	3800 mL in 1 BOTTLE	GEL	3800	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
79490-000	X PROUSA ANTISEPTIC HAND SANITIZER GEL (ALCOHOL) GEL [X-PROUSA LLC]	2	Legacy NDC, 7 package rows	20200827_ab6cfcf8-19eb-a2e9-e053-2a95a90a5828.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
2277550	ethanol 72 % Topical Gel	PSN	ab6cfcf8-19eb-a2e9-e053-2a95a90a5828	2
2277550	ethanol 0.72 ML/ML Topical Gel	SCD	ab6cfcf8-19eb-a2e9-e053-2a95a90a5828	2
2277550	ethanol 72 % Topical Gel	SY	ab6cfcf8-19eb-a2e9-e053-2a95a90a5828	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
79490-000-01	79490000001	30 mL in 1 BOTTLE (79490-000-01)	30 ml	2020-06-21	0000-00-00	No	No	Current
79490-000-02	79490000002	60 mL in 1 BOTTLE (79490-000-02)	60 ml	2020-06-21	0000-00-00	No	No	Current
79490-000-04	79490000004	118 mL in 1 BOTTLE (79490-000-04)	118 ml	2020-06-21	0000-00-00	No	No	Current
79490-000-08	79490000008	240 mL in 1 BOTTLE (79490-000-08)	240 ml	2020-06-21	0000-00-00	No	No	Current
79490-000-16	79490000016	470 mL in 1 BOTTLE (79490-000-16)	470 ml	2020-06-21	0000-00-00	No	No	Current
79490-000-32	79490000032	950 mL in 1 BOTTLE (79490-000-32)	950 ml	2020-06-21	0000-00-00	No	No	Current
79490-000-38	79490000038	3800 mL in 1 BOTTLE (79490-000-38)	3800 ml	2020-06-21	0000-00-00	No	No	Current