Antiseptic Gel

Product NDC: 76598-001
11-digit product format: 765980001
Labeler code: 76598
Product ID: 76598-001_a58fd8fd-27be-f4b0-e053-2995a90af472
Type: HUMAN OTC DRUG
Nonproprietary name: Alcohol
Dosage form: GEL
Route: TOPICAL
Labeler: Bioagaves de la Costa, S.A. de C.V.
Application: part333A
Marketing category: OTC MONOGRAPH NOT FINAL
Marketing start: 2020-04-24
Marketing end: 0000-00-00
Substance: ALCOHOL
Active strength: 80 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 · 10 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	76598-001		I	Inactivated by FDA	2026-10-05
excluded package	package	76598-001	76598-001-01	I	Inactivated by FDA	2026-10-05
excluded package	package	76598-001	76598-001-02	I	Inactivated by FDA	2026-10-05
excluded package	package	76598-001	76598-001-03	I	Inactivated by FDA	2026-10-05
excluded package	package	76598-001	76598-001-04	I	Inactivated by FDA	2026-10-05
excluded package	package	76598-001	76598-001-05	I	Inactivated by FDA	2026-10-05
excluded package	package	76598-001	76598-001-06	I	Inactivated by FDA	2026-10-05
excluded package	package	76598-001	76598-001-07	I	Inactivated by FDA	2026-10-05
excluded package	package	76598-001	76598-001-08	I	Inactivated by FDA	2026-10-05
excluded package	package	76598-001	76598-001-09	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 · 150 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	76598-001-07	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	76598-001-04	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	76598-001-03	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	76598-001-06	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	76598-001-02	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	76598-001-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	76598-001-09	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	76598-001-01	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	76598-001-08	`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	76598-001-07	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	76598-001-04	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	76598-001-03	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	76598-001-06	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	76598-001-02	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	76598-001-05	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	76598-001-09	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	76598-001-01	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	76598-001-08	`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	76598-001-07	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	76598-001-04	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	76598-001-03	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	76598-001-06	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	76598-001-02	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	76598-001-05	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	76598-001-09	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	76598-001-01	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	76598-001-08	`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	76598-001-07	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	76598-001-04	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	76598-001-03	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	76598-001-06	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	76598-001-02	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	76598-001-05	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	76598-001-09	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	76598-001-01	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	76598-001-08	`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	76598-001-07	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	76598-001-04	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	76598-001-03	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	76598-001-06	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	76598-001-02	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	76598-001-05	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	76598-001-09	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	76598-001-01	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	76598-001-08	`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	76598-001-07	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	76598-001-04	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	76598-001-03	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	76598-001-06	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	76598-001-02	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	76598-001-05	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	76598-001-09	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	76598-001-01	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	76598-001-08	`cdf11ea48f46…`	`ba0047e9e063…`

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
76598-001-01	a40f1bf3-83a2-a029-e053-2a95a90a6afa
76598-001-02	a40f1bf3-83a2-a029-e053-2a95a90a6afa
76598-001-03	a40f1bf3-83a2-a029-e053-2a95a90a6afa
76598-001-04	a40f1bf3-83a2-a029-e053-2a95a90a6afa
76598-001-05	a40f1bf3-83a2-a029-e053-2a95a90a6afa
76598-001-06	a40f1bf3-83a2-a029-e053-2a95a90a6afa
76598-001-07	a40f1bf3-83a2-a029-e053-2a95a90a6afa
76598-001-08	a40f1bf3-83a2-a029-e053-2a95a90a6afa
76598-001-09	a40f1bf3-83a2-a029-e053-2a95a90a6afa

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
76598-001-01	Antiseptic Gel	250 mL in 1 BOTTLE	GEL	250	3
76598-001-02	Antiseptic Gel	500 mL in 1 BOTTLE	GEL	500	3
76598-001-03	Antiseptic Gel	1000 mL in 1 BOTTLE	GEL	1000	3
76598-001-04	Antiseptic Gel	5000 mL in 1 BOTTLE	GEL	5000	3
76598-001-05	Antiseptic Gel	20000 mL in 1 PACKAGE	GEL	20000	3
76598-001-06	Antiseptic Gel	200000 mL in 1 DRUM	GEL	200000	3
76598-001-07	Antiseptic Gel	1000000 mL in 1 TANK	GEL	1000000	3
76598-001-08	Antiseptic Gel	4500 mL in 1 BOTTLE	GEL	4500	3
76598-001-09	Antiseptic Gel	60 mL in 1 BOTTLE	GEL	60	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
76598-001	ANTISEPTIC GEL (ALCOHOL) GEL [BIOAGAVES DE LA COSTA, S.A. DE C.V.]	3	Legacy NDC, 9 package rows	20200514_a40f1bf3-83a2-a029-e053-2a95a90a6afa.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
1041498	ethanol 80 % Topical Gel	PSN	a40f1bf3-83a2-a029-e053-2a95a90a6afa	3
1041498	ethanol 0.8 ML/ML Topical Gel	SCD	a40f1bf3-83a2-a029-e053-2a95a90a6afa	3
1041498	ethanol 80 % Topical Gel	SY	a40f1bf3-83a2-a029-e053-2a95a90a6afa	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
76598-001-01	76598000101	250 mL in 1 BOTTLE (76598-001-01)	250 ml	2020-04-24	0000-00-00	No	No	Current
76598-001-02	76598000102	500 mL in 1 BOTTLE (76598-001-02)	500 ml	2020-04-24	0000-00-00	No	No	Current
76598-001-03	76598000103	1000 mL in 1 BOTTLE (76598-001-03)	1000 ml	2020-04-24	0000-00-00	No	No	Current
76598-001-04	76598000104	5000 mL in 1 BOTTLE (76598-001-04)	5000 ml	2020-04-24	0000-00-00	No	No	Current
76598-001-05	76598000105	20000 mL in 1 PACKAGE (76598-001-05)	20000 ml	2020-04-24	0000-00-00	No	No	Current
76598-001-06	76598000106	200000 mL in 1 DRUM (76598-001-06)	200000 ml	2020-04-24	0000-00-00	No	No	Current
76598-001-07	76598000107	1000000 mL in 1 TANK (76598-001-07)	1000000 ml	2020-04-24	0000-00-00	No	No	Current
76598-001-08	76598000108	4500 mL in 1 BOTTLE (76598-001-08)	4500 ml	2020-04-24	0000-00-00	No	No	Current
76598-001-09	76598000109	60 mL in 1 BOTTLE (76598-001-09)	60 ml	2020-04-24	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Antiseptic Gel - Bioagaves de la Costa, S.A. de C.V.	Bioagaves de la Costa, S.A. de C.V.	2020-05-13	HUMAN OTC DRUG LABEL	3