Zylast Antiseptic

Product NDC: 57362-465
Requested package NDC: 57362-465-48
11-digit product format: 573620465
Labeler code: 57362
Product ID: 57362-465_4034b4f1-0357-ad88-e063-6294a90ac287
Type: HUMAN OTC DRUG
Nonproprietary name: Ethyl Alcohol
Dosage form: GEL
Route: TOPICAL
Labeler: Innovative BioDefense
Application: 505G(a)(3)
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2015-04-24
Substance: ALCOHOL
Active strength: 44.9 mL/59.1mL
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	57362-465	57362-465-48	I	Inactivated by FDA		2026-08-11

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 1 · 19 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	`8dfbde2a14a4…`	`c9ff85d89658…`

Additional Listing Data#

Finished product: Yes
Brand name base: Zylast Antiseptic
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ALCOHOL	44.9 mL/59.1mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
3K9958V90M	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1535597	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
178190dc-7c68-6485-e054-00144ff8d46c	Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Indexing SPL table
NDC	Effective	Indexing SPL	Related label
57362-465-01	2023-11-12	ba0f9c33-4ec8-a910-e053-dadaa90a0b85	Zylast Antiseptic
57362-465-14	2023-11-12	ba0f9c33-4ec8-a910-e053-dadaa90a0b85	Zylast Antiseptic
57362-465-01	2023-01-30	ba0f9c33-4ec8-a910-e053-dadaa90a0b85	Zylast Antiseptic
57362-465-14	2023-01-30	ba0f9c33-4ec8-a910-e053-dadaa90a0b85	Zylast Antiseptic
57362-465-01	2021-08-23	ba0f9c33-4ec8-a910-e053-dadaa90a0b85	Zylast Antiseptic
57362-465-04	2021-07-23	c7ccaba7-1512-fd44-e053-dadaa90aa01b	Antiseptic 8oz Drug Facts
57362-465-48	2021-07-23	c7ccaba7-1512-fd44-e053-dadaa90aa01b	Antiseptic 8oz Drug Facts
57362-465-01	2021-01-29	ba0f9c33-4ec8-a910-e053-dadaa90a0b85	Zylast Antiseptic

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
57362-465-01	Zylast Antiseptic	59.1 mL in 1 BOTTLE, PLASTIC	GEL	59.1	7
57362-465-14	Zylast Antiseptic	1000 mL in 1 CARTRIDGE	GEL	1000	7
57362-465-04	Zylast Antiseptic	236.6 mL in 1 BOTTLE, PLASTIC	GEL	236.6	3
57362-465-48	Zylast Antiseptic	250 mL in 1 BOTTLE, PLASTIC	GEL	250	3

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ALCOHOL	ACTIVE INGREDIENT	3K9958V90M	ZYLAST ANTISEPTIC (ETHYL ALCOHOL) GEL [INNOVATIVE BIODEFENSE]	1
ALCOHOL	ACTIVE INGREDIENT	3K9958V90M	ZYLAST ANTISEPTIC (ETHYL ALCOHOL) GEL [INNOVATIVE BIODEFENSE]	1
ALCOHOL	ACTIVE MOIETY	3K9958V90M	ZYLAST ANTISEPTIC (ETHYL ALCOHOL) GEL [INNOVATIVE BIODEFENSE]	1
ALCOHOL	ACTIVE MOIETY	3K9958V90M	ZYLAST ANTISEPTIC (ETHYL ALCOHOL) GEL [INNOVATIVE BIODEFENSE]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	ZYLAST ANTISEPTIC (ETHYL ALCOHOL) GEL [INNOVATIVE BIODEFENSE]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	ZYLAST ANTISEPTIC (ETHYL ALCOHOL) GEL [INNOVATIVE BIODEFENSE]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
57362-465	ZYLAST ANTISEPTIC (ETHYL ALCOHOL) GEL [INNOVATIVE BIODEFENSE]	6	Current NDC, Legacy NDC, 2 package rows	20241208_178190dc-7c68-6485-e054-00144ff8d46c.zip
57362-465	ZYLAST ANTISEPTIC (ETHYL ALCOHOL) GEL [INNOVATIVE BIODEFENSE]	3	Current NDC, Legacy NDC, 2 package rows	20200827_17a70b04-3e61-27ae-e054-00144ff8d46c.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Zylast Antiseptic	ETHYL ALCOHOL	Innovative BioDefense	178190dc-7c68-6485-e054-00144ff8d46c	2025-10-02	Warnings	Exact identifier ndc (product): 57362-465

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
1535597	ethanol 76 % Topical Gel	PSN	178190dc-7c68-6485-e054-00144ff8d46c	7
1535597	ethanol 0.76 ML/ML Topical Gel	SCD	178190dc-7c68-6485-e054-00144ff8d46c	7
1535597	ethanol 76 % Topical Gel	SY	178190dc-7c68-6485-e054-00144ff8d46c	7
1535597	ethanol 76 % Topical Gel	PSN	17a70b04-3e61-27ae-e054-00144ff8d46c	3
1535597	ethanol 0.76 ML/ML Topical Gel	SCD	17a70b04-3e61-27ae-e054-00144ff8d46c	3
1535597	ethanol 76 % Topical Gel	SY	17a70b04-3e61-27ae-e054-00144ff8d46c	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
57362-465-48	57362046548	250 mL in 1 BOTTLE, PLASTIC (57362-465-48)	250 ml	2020-08-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Zylast Antiseptic	Innovative BioDefense	2025-10-02	HUMAN OTC DRUG LABEL	7
Antiseptic 8oz Drug Facts	Innovative BioDefense	2020-08-26	HUMAN OTC DRUG LABEL	3