BV BYE VIRUS 99

Product NDC: 78501-4000
11-digit product format: 785014000
Labeler code: 78501
Product ID: 78501-4000_aa58fdcb-cb60-ec70-e053-2a95a90ae5c5
Type: HUMAN OTC DRUG
Nonproprietary name: ETHYL ALCOHOL
Dosage form: GEL
Route: TOPICAL
Labeler: COMERCIAL GOURA,S. DE R.L.
Application: part333A
Marketing category: OTC MONOGRAPH NOT FINAL
Marketing start: 2020-06-29
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 · 9 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	78501-4000		I	Inactivated by FDA	2026-10-05
excluded package	package	78501-4000	78501-4000-1	I	Inactivated by FDA	2026-10-05
excluded package	package	78501-4000	78501-4000-2	I	Inactivated by FDA	2026-10-05
excluded package	package	78501-4000	78501-4000-4	I	Inactivated by FDA	2026-10-05
excluded package	package	78501-4000	78501-4000-5	I	Inactivated by FDA	2026-10-05
excluded package	package	78501-4000	78501-4000-6	I	Inactivated by FDA	2026-10-05
excluded package	package	78501-4000	78501-4000-7	I	Inactivated by FDA	2026-10-05
excluded package	package	78501-4000	78501-4000-8	I	Inactivated by FDA	2026-10-05
excluded package	package	78501-4000	78501-4000-9	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 · 162 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	78501-4000-7	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	78501-4000-9	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	78501-4000-1	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	78501-4000-5	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	78501-4000-8	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	78501-4000-4	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	78501-4000-2	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	78501-4000-6	`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	78501-4000-7	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	78501-4000-9	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	78501-4000-1	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	78501-4000-5	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	78501-4000-8	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	78501-4000-4	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	78501-4000-2	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	78501-4000-6	`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	78501-4000-7	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	78501-4000-9	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	78501-4000-1	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	78501-4000-5	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	78501-4000-8	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	78501-4000-4	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	78501-4000-2	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	78501-4000-6	`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	78501-4000-7	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	78501-4000-9	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	78501-4000-1	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	78501-4000-5	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	78501-4000-8	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	78501-4000-4	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	78501-4000-2	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	78501-4000-6	`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	78501-4000-7	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	78501-4000-9	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	78501-4000-1	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	78501-4000-5	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	78501-4000-8	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	78501-4000-4	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	78501-4000-2	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	78501-4000-6	`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	78501-4000-7	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	78501-4000-9	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	78501-4000-1	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	78501-4000-5	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	78501-4000-8	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	78501-4000-4	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	78501-4000-2	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	78501-4000-6	`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	78501-4000-7	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	78501-4000-9	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	78501-4000-1	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	78501-4000-5	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	78501-4000-8	`302b2466d912…`	`e7b80fea0513…`

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
78501-4000-1	BV BYE VIRUS HAND SANITIZER GEL
78501-4000-2	BV BYE VIRUS HAND SANITIZER GEL
78501-4000-4	BV BYE VIRUS HAND SANITIZER GEL
78501-4000-5	BV BYE VIRUS HAND SANITIZER GEL
78501-4000-6	BV BYE VIRUS HAND SANITIZER GEL
78501-4000-7	BV BYE VIRUS HAND SANITIZER GEL
78501-4000-8	BV BYE VIRUS HAND SANITIZER GEL
78501-4000-9	BV BYE VIRUS HAND SANITIZER GEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
78501-4000-1	BV BYE VIRUS 99	19000 mL in 1 PAIL	GEL	19000	2
78501-4000-2	BV BYE VIRUS 99	4000 mL in 1 JUG	GEL	4000	2
78501-4000-4	BV BYE VIRUS 99	60 mL in 1 BOTTLE	GEL	60	2
78501-4000-5	BV BYE VIRUS 99	30 mL in 1 BOTTLE	GEL	30	2
78501-4000-6	BV BYE VIRUS 99	125 mL in 1 BOTTLE	GEL	125	2
78501-4000-7	BV BYE VIRUS 99	250 mL in 1 BOTTLE	GEL	250	2
78501-4000-8	BV BYE VIRUS 99	500 mL in 1 BOTTLE	GEL	500	2
78501-4000-9	BV BYE VIRUS 99	1000 mL in 1 BOTTLE	GEL	1000	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
78501-4000	BV BYE VIRUS 99 (ETHYL ALCOHOL) GEL [COMERCIAL GOURA,S. DE R.L.]	2	Legacy NDC, 8 package rows	20200714_a9338a30-77a3-404e-e053-2a95a90a2bf9.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
3K9958V90M	ALCOHOL	64-17-5	ALCOHOL

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
78501-4000-1	78501400001	19000 mL in 1 PAIL (78501-4000-1)	19000 ml	2020-06-29	0000-00-00	No	No	Current
78501-4000-2	78501400002	4000 mL in 1 JUG (78501-4000-2)	4000 ml	2020-06-29	0000-00-00	No	No	Current
78501-4000-4	78501400004	60 mL in 1 BOTTLE (78501-4000-4)	60 ml	2020-06-29	0000-00-00	No	No	Current
78501-4000-5	78501400005	30 mL in 1 BOTTLE (78501-4000-5)	30 ml	2020-06-29	0000-00-00	No	No	Current
78501-4000-6	78501400006	125 mL in 1 BOTTLE (78501-4000-6)	125 ml	2020-06-29	0000-00-00	No	No	Current
78501-4000-7	78501400007	250 mL in 1 BOTTLE (78501-4000-7)	250 ml	2020-06-29	0000-00-00	No	No	Current
78501-4000-8	78501400008	500 mL in 1 BOTTLE (78501-4000-8)	500 ml	2020-06-29	0000-00-00	No	No	Current
78501-4000-9	78501400009	1000 mL in 1 BOTTLE (78501-4000-9)	1000 ml	2020-06-29	0000-00-00	No	No	Current