Antiseptic Gel Hand Sanitizer

Product NDC: 76598-004
11-digit product format: 765980004
Labeler code: 76598
Product ID: 76598-004_ae6ae49e-97c8-9ba1-e053-2a95a90ac170
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: 70 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 · 11 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	76598-004		I	Inactivated by FDA	2026-10-12
excluded package	package	76598-004	76598-004-01	I	Inactivated by FDA	2026-10-12
excluded package	package	76598-004	76598-004-02	I	Inactivated by FDA	2026-10-12
excluded package	package	76598-004	76598-004-03	I	Inactivated by FDA	2026-10-12
excluded package	package	76598-004	76598-004-04	I	Inactivated by FDA	2026-10-12
excluded package	package	76598-004	76598-004-05	I	Inactivated by FDA	2026-10-12
excluded package	package	76598-004	76598-004-06	I	Inactivated by FDA	2026-10-12
excluded package	package	76598-004	76598-004-07	I	Inactivated by FDA	2026-10-12
excluded package	package	76598-004	76598-004-08	I	Inactivated by FDA	2026-10-12
excluded package	package	76598-004	76598-004-09	I	Inactivated by FDA	2026-10-12
excluded package	package	76598-004	76598-004-10	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 · 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	76598-004-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	76598-004-01	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	76598-004-10	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	76598-004-03	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	76598-004-08	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	76598-004-06	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	76598-004-07	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	76598-004-04	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	76598-004-02	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	76598-004-09	`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	76598-004-05	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	76598-004-01	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	76598-004-10	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	76598-004-03	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	76598-004-08	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	76598-004-06	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	76598-004-07	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	76598-004-04	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	76598-004-02	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	76598-004-09	`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	76598-004-05	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	76598-004-01	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	76598-004-10	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	76598-004-03	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	76598-004-08	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	76598-004-06	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	76598-004-07	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	76598-004-04	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	76598-004-02	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	76598-004-09	`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	76598-004-05	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	76598-004-01	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	76598-004-10	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	76598-004-03	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	76598-004-08	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	76598-004-06	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	76598-004-07	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	76598-004-04	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	76598-004-02	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	76598-004-09	`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	76598-004-05	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	76598-004-01	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	76598-004-10	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	76598-004-03	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	76598-004-08	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	76598-004-06	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	76598-004-07	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	76598-004-04	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	76598-004-02	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	76598-004-09	`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	76598-004-05	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	76598-004-01	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	76598-004-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	76598-004-03	`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
76598-004-01	a873f92e-561a-f1e8-e053-2995a90ad2f3
76598-004-02	a873f92e-561a-f1e8-e053-2995a90ad2f3
76598-004-03	a873f92e-561a-f1e8-e053-2995a90ad2f3
76598-004-04	a873f92e-561a-f1e8-e053-2995a90ad2f3
76598-004-05	a873f92e-561a-f1e8-e053-2995a90ad2f3
76598-004-06	a873f92e-561a-f1e8-e053-2995a90ad2f3
76598-004-07	a873f92e-561a-f1e8-e053-2995a90ad2f3
76598-004-08	a873f92e-561a-f1e8-e053-2995a90ad2f3
76598-004-09	a873f92e-561a-f1e8-e053-2995a90ad2f3
76598-004-10	a873f92e-561a-f1e8-e053-2995a90ad2f3

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
76598-004-01	Antiseptic Gel Hand Sanitizer70 v/v	200 mL in 1 BOTTLE	GEL	200	2
76598-004-02	Antiseptic Gel Hand Sanitizer70 v/v	60 mL in 1 BOTTLE	GEL	60	2
76598-004-03	Antiseptic Gel Hand Sanitizer70 v/v	250 mL in 1 BOTTLE	GEL	250	2
76598-004-04	Antiseptic Gel Hand Sanitizer70 v/v	500 mL in 1 BOTTLE	GEL	500	2
76598-004-05	Antiseptic Gel Hand Sanitizer70 v/v	1000 mL in 1 PACKAGE	GEL	1000	2
76598-004-06	Antiseptic Gel Hand Sanitizer70 v/v	3785 mL in 1 DRUM	GEL	3785	2
76598-004-07	Antiseptic Gel Hand Sanitizer70 v/v	1000000 mL in 1 TANK	GEL	1000000	2
76598-004-08	Antiseptic Gel Hand Sanitizer70 v/v	20000 mL in 1 DRUM	GEL	20000	2
76598-004-09	Antiseptic Gel Hand Sanitizer70 v/v	200000 mL in 1 TANK	GEL	200000	2
76598-004-10	Antiseptic Gel Hand Sanitizer70 v/v	4 mL in 1 POUCH	GEL	4	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
76598-004	ANTISEPTIC GEL HAND SANITIZER 70 V/V (ALCOHOL) GEL [BIOAGAVES DE LA COSTA, S.A. DE C.V.]	2	Legacy NDC, 10 package rows	20200904_a873f92e-561a-f1e8-e053-2995a90ad2f3.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
581662	ethanol 70 % Topical Gel	PSN	a873f92e-561a-f1e8-e053-2995a90ad2f3	2
581662	ethanol 0.7 ML/ML Topical Gel	SCD	a873f92e-561a-f1e8-e053-2995a90ad2f3	2
581662	ethanol 70 % Topical Gel	SY	a873f92e-561a-f1e8-e053-2995a90ad2f3	2
581662	ethyl alcohol 70 % Topical Gel	SY	a873f92e-561a-f1e8-e053-2995a90ad2f3	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
76598-004-01	76598000401	200 mL in 1 BOTTLE (76598-004-01)	200 ml	2020-04-24	0000-00-00	No	No	Current
76598-004-02	76598000402	60 mL in 1 BOTTLE (76598-004-02)	60 ml	2020-04-24	0000-00-00	No	No	Current
76598-004-03	76598000403	250 mL in 1 BOTTLE (76598-004-03)	250 ml	2020-04-24	0000-00-00	No	No	Current
76598-004-04	76598000404	500 mL in 1 BOTTLE (76598-004-04)	500 ml	2020-04-24	0000-00-00	No	No	Current
76598-004-05	76598000405	1000 mL in 1 PACKAGE (76598-004-05)	1000 ml	2020-04-24	0000-00-00	No	No	Current
76598-004-06	76598000406	3785 mL in 1 DRUM (76598-004-06)	3785 ml	2020-04-24	0000-00-00	No	No	Current
76598-004-07	76598000407	1000000 mL in 1 TANK (76598-004-07)	1000000 ml	2020-04-24	0000-00-00	No	No	Current
76598-004-08	76598000408	20000 mL in 1 DRUM (76598-004-08)	20000 ml	2020-04-24	0000-00-00	No	No	Current
76598-004-09	76598000409	200000 mL in 1 TANK (76598-004-09)	200000 ml	2020-04-24	0000-00-00	No	No	Current
76598-004-10	76598000410	4 mL in 1 POUCH (76598-004-10)	4 ml	2020-09-03	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Antiseptic Gel Hand Sanitizer 70 v/v	Bioagaves de la Costa, S.A. de C.V.	2020-09-03	HUMAN OTC DRUG LABEL	2