Alcohol-Free Antiseptic Gel

Product NDC: 76598-010
11-digit product format: 765980010
Labeler code: 76598
Product ID: 76598-010_adc00888-033b-d9a1-e053-2995a90a7d97
Type: HUMAN OTC DRUG
Nonproprietary name: BENZALKONIUM CHLORIDE
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: BENZALKONIUM CHLORIDE
Active strength: 13 mg/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 · 11 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	76598-010		I	Inactivated by FDA	2026-10-05
excluded package	package	76598-010	76598-010-01	I	Inactivated by FDA	2026-10-05
excluded package	package	76598-010	76598-010-02	I	Inactivated by FDA	2026-10-05
excluded package	package	76598-010	76598-010-03	I	Inactivated by FDA	2026-10-05
excluded package	package	76598-010	76598-010-04	I	Inactivated by FDA	2026-10-05
excluded package	package	76598-010	76598-010-05	I	Inactivated by FDA	2026-10-05
excluded package	package	76598-010	76598-010-06	I	Inactivated by FDA	2026-10-05
excluded package	package	76598-010	76598-010-07	I	Inactivated by FDA	2026-10-05
excluded package	package	76598-010	76598-010-08	I	Inactivated by FDA	2026-10-05
excluded package	package	76598-010	76598-010-09	I	Inactivated by FDA	2026-10-05
excluded package	package	76598-010	76598-010-10	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 · 165 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	76598-010-09	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	76598-010-02	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	76598-010-07	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	76598-010-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	76598-010-03	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	76598-010-08	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	76598-010-04	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	76598-010-06	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	76598-010-01	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	76598-010-10	`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	76598-010-09	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	76598-010-02	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	76598-010-07	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	76598-010-05	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	76598-010-03	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	76598-010-08	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	76598-010-04	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	76598-010-06	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	76598-010-01	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	76598-010-10	`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	76598-010-09	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	76598-010-02	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	76598-010-07	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	76598-010-05	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	76598-010-03	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	76598-010-08	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	76598-010-04	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	76598-010-06	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	76598-010-01	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	76598-010-10	`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	76598-010-09	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	76598-010-02	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	76598-010-07	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	76598-010-05	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	76598-010-03	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	76598-010-08	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	76598-010-04	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	76598-010-06	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	76598-010-01	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	76598-010-10	`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	76598-010-09	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	76598-010-02	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	76598-010-07	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	76598-010-05	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	76598-010-03	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	76598-010-08	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	76598-010-04	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	76598-010-06	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	76598-010-01	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	76598-010-10	`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	76598-010-09	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	76598-010-02	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	76598-010-07	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	76598-010-05	`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
76598-010-01	adc00888-033c-d9a1-e053-2995a90a7d97
76598-010-02	adc00888-033c-d9a1-e053-2995a90a7d97
76598-010-03	adc00888-033c-d9a1-e053-2995a90a7d97
76598-010-04	adc00888-033c-d9a1-e053-2995a90a7d97
76598-010-05	adc00888-033c-d9a1-e053-2995a90a7d97
76598-010-06	adc00888-033c-d9a1-e053-2995a90a7d97
76598-010-07	adc00888-033c-d9a1-e053-2995a90a7d97
76598-010-08	adc00888-033c-d9a1-e053-2995a90a7d97
76598-010-09	adc00888-033c-d9a1-e053-2995a90a7d97
76598-010-10	adc00888-033c-d9a1-e053-2995a90a7d97

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
76598-010-01	Alcohol-Free Antiseptic Gel	4 mL in 1 POUCH	GEL	4	1
76598-010-02	Alcohol-Free Antiseptic Gel	60 mL in 1 BOTTLE	GEL	60	1
76598-010-03	Alcohol-Free Antiseptic Gel	250 mL in 1 BOTTLE	GEL	250	1
76598-010-04	Alcohol-Free Antiseptic Gel	500 mL in 1 BOTTLE	GEL	500	1
76598-010-05	Alcohol-Free Antiseptic Gel	1000 mL in 1 BOTTLE	GEL	1000	1
76598-010-06	Alcohol-Free Antiseptic Gel	3780 mL in 1 BOTTLE	GEL	3780	1
76598-010-07	Alcohol-Free Antiseptic Gel	4500 mL in 1 BOTTLE	GEL	4500	1
76598-010-08	Alcohol-Free Antiseptic Gel	20000 mL in 1 JUG	GEL	20000	1
76598-010-09	Alcohol-Free Antiseptic Gel	200000 mL in 1 JUG	GEL	200000	1
76598-010-10	Alcohol-Free Antiseptic Gel	1000000 mL in 1 JUG	GEL	1000000	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
76598-010	ALCOHOL-FREE ANTISEPTIC GEL (BENZALKONIUM CHLORIDE) GEL [BIOAGAVES DE LA COSTA, S.A. DE C.V.]	1	Legacy NDC, 10 package rows	20200827_adc00888-033c-d9a1-e053-2995a90a7d97.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
F5UM2KM3W7	BENZALKONIUM CHLORIDE	8001-54-5	BENZALKONIUM CHLORIDE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
76598-010-01	76598001001	4 mL in 1 POUCH (76598-010-01)	4 ml	2020-04-24	0000-00-00	No	No	Current
76598-010-02	76598001002	60 mL in 1 BOTTLE (76598-010-02)	60 ml	2020-04-24	0000-00-00	No	No	Current
76598-010-03	76598001003	250 mL in 1 BOTTLE (76598-010-03)	250 ml	2020-04-24	0000-00-00	No	No	Current
76598-010-04	76598001004	500 mL in 1 BOTTLE (76598-010-04)	500 ml	2020-04-24	0000-00-00	No	No	Current
76598-010-05	76598001005	1000 mL in 1 BOTTLE (76598-010-05)	1000 ml	2020-04-24	0000-00-00	No	No	Current
76598-010-06	76598001006	3780 mL in 1 BOTTLE (76598-010-06)	3780 ml	2020-04-24	0000-00-00	No	No	Current
76598-010-07	76598001007	4500 mL in 1 BOTTLE (76598-010-07)	4500 ml	2020-04-24	0000-00-00	No	No	Current
76598-010-08	76598001008	20000 mL in 1 JUG (76598-010-08)	20000 ml	2020-04-24	0000-00-00	No	No	Current
76598-010-09	76598001009	200000 mL in 1 JUG (76598-010-09)	200000 ml	2020-04-24	0000-00-00	No	No	Current
76598-010-10	76598001010	1000000 mL in 1 JUG (76598-010-10)	1000000 ml	2020-04-24	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Alcohol-Free Antiseptic Gel - Bioagaves de la Costa, S.A. de C.V.	Bioagaves de la Costa, S.A. de C.V.	2020-08-25	HUMAN OTC DRUG LABEL	1