FDA.reportPublic FDA data

Zylast Antiseptic S

Product NDC
57362-466
11-digit product format
573620466
Labeler code
57362
Product ID
57362-466_050d4721-0bd7-0fdc-e063-6394a90aa7ff
Type
HUMAN OTC DRUG
Nonproprietary name
Ethyl Alcohol
Dosage form
LIQUID
Route
TOPICAL
Labeler
Innovative BioDefense
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2019-01-15
Substance
ALCOHOL
Active strength
760 mL/1000mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

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 · 12 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage57362-466-1786f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage57362-466-1686f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage57362-466-4186f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage57362-466-17bd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage57362-466-16bd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage57362-466-41bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage57362-466-178dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage57362-466-168dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage57362-466-418dfbde2a14a4…c9ff85d89658…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ALCOHOL760 mL/1000mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
3K9958V90MInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1491797Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
86857d95-56b4-2eb4-e053-2a91aa0ad557Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
57362-466-162022-04-16Zylast Antiseptic S
57362-466-172022-04-16Zylast Antiseptic S
57362-466-412022-04-16Zylast Antiseptic S
57362-466-162021-07-23Zylast Antiseptic S
57362-466-172021-07-23Zylast Antiseptic S
57362-466-412021-07-23Zylast Antiseptic S

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57362-466-16Zylast Antiseptic S1000 mL in 1 CARTRIDGELIQUID10005
57362-466-17Zylast Antiseptic S10 mL in 1 VIAL, GLASSLIQUID105
57362-466-41Zylast Antiseptic S10 mL in 1 VIAL, GLASSLIQUID105

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57362-466ZYLAST ANTISEPTIC S (ETHYL ALCOHOL) LIQUID [INNOVATIVE BIODEFENSE]5Current NDC, Legacy NDC, 3 package rows20231113_86857d95-56b4-2eb4-e053-2a91aa0ad557.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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Zylast Antiseptic SETHYL ALCOHOLInnovative BioDefense86857d95-56b4-2eb4-e053-2a91aa0ad5572023-01-01WarningsExact identifier
ndc (product): 57362-466

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1491797ethanol 76 % Topical SolutionPSN86857d95-56b4-2eb4-e053-2a91aa0ad5575
1491797ethanol 0.76 ML/ML Topical SolutionSCD86857d95-56b4-2eb4-e053-2a91aa0ad5575
1491797ethanol 76 % Topical SolutionSY86857d95-56b4-2eb4-e053-2a91aa0ad5575

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
57362-466-16573620466161000 mL in 1 CARTRIDGE (57362-466-16) 1000 ml2019-01-150000-00-00NoNoCurrent
57362-466-175736204661710 mL in 1 VIAL, GLASS (57362-466-17) 10 ml2019-01-150000-00-00NoNoCurrent
57362-466-415736204664110 mL in 1 VIAL, GLASS (57362-466-41) 10 ml2019-01-150000-00-00NoNoCurrent