FDA.reportPublic FDA data

NDC 57362-464-03 - ZylastXP Antiseptic

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
57362-464
Requested NDC
57362-464-03
Package NDCs from labels
57362-464-00, 57362-464-03, 57362-464-13, 57362-464-04
Manufacturer
Innovative BioDefense
Effective date
2021-08-26
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
ZylastXP Antiseptic - Innovative BioDefenseInnovative BioDefense2021-08-26HUMAN OTC DRUG LABEL
ZylastXP Antiseptic - Innovative BioDefenseInnovative BioDefense2021-08-26HUMAN OTC DRUG LABEL
ZylastXP Antiseptic - Innovative BioDefenseInnovative BioDefense2021-08-26HUMAN OTC DRUG LABEL
ZylastXP Antiseptic - Innovative BioDefenseInnovative BioDefense2021-06-01HUMAN OTC DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Indexing SPL table
NDCEffectiveIndexing SPLRelated label
57362-464-002023-01-30ba0f9c33-3027-a910-e053-dadaa90a0b85Zylast Antiseptic Lotion 2oz Drug Facts
57362-464-032023-01-30ba0f9c33-260e-a910-e053-dadaa90a0b85Zylast Antiseptic Lotion 8oz Drug Facts
57362-464-042023-01-30ba0f9c33-115e-a910-e053-dadaa90a0b85Zylast Antispetic Lotion 0.5oz. Drug Facts
57362-464-132023-01-30ba0f9c33-115b-a910-e053-dadaa90a0b85Antiseptic Lotion Cartridge Drug Facts
57362-464-002021-08-26ba0f9c33-3027-a910-e053-dadaa90a0b85Zylast Antiseptic Lotion 2oz Drug Facts
57362-464-032021-08-26ba0f9c33-260e-a910-e053-dadaa90a0b85Zylast Antiseptic Lotion 8oz Drug Facts
57362-464-042021-08-26ba0f9c33-115e-a910-e053-dadaa90a0b85Zylast Antispetic Lotion 0.5oz. Drug Facts
57362-464-132021-08-26ba0f9c33-115b-a910-e053-dadaa90a0b85Antiseptic Lotion Cartridge Drug Facts
57362-464-002021-01-29ba0f9c33-3027-a910-e053-dadaa90a0b85Zylast Antiseptic Lotion 2oz Drug Facts
57362-464-032021-01-29ba0f9c33-260e-a910-e053-dadaa90a0b85Zylast Antiseptic Lotion 8oz Drug Facts
57362-464-042021-01-29ba0f9c33-115e-a910-e053-dadaa90a0b85Zylast Antispetic Lotion 0.5oz. Drug Facts
57362-464-132021-01-29ba0f9c33-115b-a910-e053-dadaa90a0b85Antiseptic Lotion Cartridge Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57362-464-00ZylastXP Antiseptic192.3 mg in 1 BOTTLE, PLASTICLOTION192.34
57362-464-03ZylastXP Antiseptic227 mg in 1 BOTTLE, PLASTICLOTION2273
57362-464-04ZylastXP Antiseptic14.2 mg in 1 TUBELOTION14.23
57362-464-13ZylastXP Antiseptic960 mg in 1 BOTTLE, PLASTICLOTION9603

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57362-464ZYLASTXP ANTISEPTIC (BENZETHONIUM CHLORIDE) LOTION [INNOVATIVE BIODEFENSE]4Legacy NDC, 1 package rows20210828_141b8704-9618-6add-e054-00144ff88e88.zip
57362-464ZYLASTXP ANTISEPTIC (BENZETHONIUM CHLORIDE) LOTION [INNOVATIVE BIODEFENSE]3Legacy NDC, 1 package rows20210827_23e46dbd-61aa-0bd1-e054-00144ff88e88.zip
57362-464ZYLASTXP ANTISEPTIC (BENZETHONIUM CHLORIDE) LOTION [INNOVATIVE BIODEFENSE]3Legacy NDC, 1 package rows20210828_2ae1e795-11d0-2996-e054-00144ff8d46c.zip
57362-464ZYLASTXP ANTISEPTIC (BENZETHONIUM CHLORIDE) LOTION [INNOVATIVE BIODEFENSE]3Legacy NDC, 1 package rows20210828_17a5768b-5f4d-507d-e054-00144ff8d46c.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BENZETHONIUM CHLORIDEACTIVE INGREDIENTPH41D05744ZYLASTXP ANTISEPTIC (BENZETHONIUM CHLORIDE) LOTION [INNOVATIVE BIODEFENSE]2
BENZETHONIUMACTIVE MOIETY1VU15B70BPZYLASTXP ANTISEPTIC (BENZETHONIUM CHLORIDE) LOTION [INNOVATIVE BIODEFENSE]2
WATERINACTIVE INGREDIENT059QF0KO0RZYLASTXP ANTISEPTIC (BENZETHONIUM CHLORIDE) LOTION [INNOVATIVE BIODEFENSE]2
BENZETHONIUM CHLORIDEACTIVE INGREDIENTPH41D05744ZYLASTXP ANTISEPTIC (BENZETHONIUM CHLORIDE) LOTION [INNOVATIVE BIODEFENSE]1
BENZETHONIUM CHLORIDEACTIVE INGREDIENTPH41D05744ZYLASTXP ANTISEPTIC (BENZETHONIUM CHLORIDE) LOTION [INNOVATIVE BIODEFENSE]1
BENZETHONIUMACTIVE MOIETY1VU15B70BPZYLASTXP ANTISEPTIC (BENZETHONIUM CHLORIDE) LOTION [INNOVATIVE BIODEFENSE]1
BENZETHONIUMACTIVE MOIETY1VU15B70BPZYLASTXP ANTISEPTIC (BENZETHONIUM CHLORIDE) LOTION [INNOVATIVE BIODEFENSE]1
WATERINACTIVE INGREDIENT059QF0KO0RZYLASTXP ANTISEPTIC (BENZETHONIUM CHLORIDE) LOTION [INNOVATIVE BIODEFENSE]1
WATERINACTIVE INGREDIENT059QF0KO0RZYLASTXP ANTISEPTIC (BENZETHONIUM CHLORIDE) LOTION [INNOVATIVE BIODEFENSE]1

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 15 · 284 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Benzethonium chloride Plus Dyclonine hydrochlorideLIQUID BANDAGEKroger Co.fe604470-917f-4cbd-a1e6-ac1dc7c57ff62026-09-02WarningsExact identifier
unii: PH41D05744
Antibacterial BarANTIBACTERIAL BARGuangzhou Zeshi Daily Chemical Co.,Ltd.5a6f7c00-1dde-26b6-e063-6294a90a19e72026-09-01WarningsExact identifier
unii: PH41D05744
KUGIG ALOE FOAMING INTIMATE WASHINTIMATE CLEANSING FOAMHong Kong KangXing Centennial Management Limited59f4d398-1186-a168-e063-6294a90ab44b2026-08-26WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERREMEDYREPACK INC.5dd5d148-6e23-41de-bff5-551b2aea95982026-08-24Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
BM BM63 DROPSCEANOTHUS, KALI ARSEN, KALI MUR, SELENIUM, THALLIUM, WIESBADENBM Private Limited59006d82-610a-2e08-e063-6394a90af1ed2026-08-14WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERCardinal Health 107, LLC48d75a7c-8329-48a8-bea0-a8c144ddf6372026-08-07Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
CharmTex Lightly Scented AntibacterialBENZETHONIUM CHLORIDEYangzhou Jyr daily chemical Co., Ltd4b642dfa-f044-4410-81e4-142f0497f0f32026-08-06WarningsExact identifier
unii: PH41D05744
GarzulysINSULIN ASPART-FSANMeitheal Pharmaceuticals Inc.30c64769-d2f7-4604-ac9e-2a6bc09506c92026-07-31Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Meridian Unwrapped antibacterial deodorantBENZETHONIUM CHLORIDEBob Barker Company Inc.c2d13d97-99ce-4a24-bdd6-684fbbf242a42026-07-29WarningsExact identifier
unii: PH41D05744
Meridian wrapped antibacterial deodorantBENZETHONIUM CHLORIDEBob Barker Company Inc.de60d4d5-87bc-4400-94e2-8307a9bb08702026-07-29WarningsExact identifier
unii: PH41D05744
DECONIMO ReconstitutionDECONIMO RECONSTITUTIONImage Amazon LLC57ab9b1c-9a18-3786-e063-6394a90a2c632026-07-28WarningsExact identifier
unii: 059QF0KO0R
Liquid BandageBENZETHONIUM CHLORIDE PLUS DYCLONINE HYDROCHLORIDEMeijer Distribution Inc036fd504-0cda-60ab-e063-6394a90a2f182026-07-27WarningsExact identifier
unii: PH41D05744
CharmTex All in One Antibacterial Shave Gel Body WashBENZETHONIUM CHLORIDEYangzhou Jyr daily chemical Co., Ltd9c9bfc61-9504-4362-8bdb-c15aa66f5a062026-07-23WarningsExact identifier
unii: PH41D05744
Meridian Unwrapped Antibacterial DeodorantBENZETHONIUM CHLORIDEYangzhou Jyr daily chemical Co., Ltdd4d5cb95-5ee5-4006-b368-f3244fc9cd6c2026-07-23WarningsExact identifier
unii: PH41D05744
Meridian Antibacterial DeodorantBENZETHONIUM CHLORIDEYangzhou Jyr daily chemical Co., Ltd8f10a193-7e01-40df-b62a-73fff5b830e32026-07-23WarningsExact identifier
unii: PH41D05744
Sterile WaterWATERCardinal Health 107, LLC9655cd02-82b5-4a75-813b-854b195514812026-07-21Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Dr. Drop NMN Vital Balance (Drop No.1 Cream 90g)NMN (NICOTINAMIDE MONONUCLEOTIDE), ECTOIN (ECTOINE)Reedfresh Co., LTD55d703ca-ff9d-0dbc-e063-6294a90ab6b12026-07-05WarningsExact identifier
unii: 059QF0KO0R
Eyesaline Eyewash ConcentratePURIFIED WATERProtective Industrial Products, Inc.558e5926-9027-d3f6-e063-6294a90ab1212026-07-02WarningsExact identifier
unii: 059QF0KO0R
Fendall 2000 Pure FlowPURIFIED WATERProtective Industrial Products, Inc.55a1d07e-0006-0c75-e063-6394a90a7acc2026-07-02WarningsExact identifier
unii: 059QF0KO0R
Fendall 1000 Pure FlowPURIFIED WATERProtective Industrial Products, Inc.55a2f4da-bb1e-8ead-e063-6394a90af72e2026-07-02WarningsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.