FDA.reportPublic FDA data

NDC 57362-464-13 - 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
57362-464-13
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 3 of 14 · 278 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dr. NumbLIDOCAINE AND BENZETHONIUM CHLORIDE CREAMShinpharma Incd8cdccdb-775b-4970-a6ea-50b62df221d62026-04-30WarningsExact identifier
unii: PH41D05744
anzoon ANTISEPTIC WIPESBENZETHONIUM CHLORIDE/BENZALKONIUM CHLORIDEShandong ACZ Biotechnology Co., Ltd.506cd089-f9a7-d9e5-e063-6394a90af6962026-04-27WarningsExact identifier
unii: PH41D05744
Sterilized wet wipesSTERILIZED WET WIPESShandong Aishule Hygiene Products Co., Ltdf7ca1799-eee4-66f0-e053-6294a90a273f2026-04-25WarningsExact identifier
unii: PH41D05744
Sterilized wet wipesSTERILIZED WET WIPESJINGXIN GROUP (M) SDN BHD3952873e-5e3f-1bff-e063-6294a90a8a622026-04-25WarningsExact identifier
unii: PH41D05744
KIDS TOOTHPASTE, FOR CAVITY PROTECTIONKIDS TOOTHPASTE FOR CAVITY PROTECTIONShulisa (Foshan) Daily ChemicalIndustry Co., Ltd4e8fab9e-f05c-5e2f-e063-6294a90aecf92026-04-03WarningsExact identifier
unii: 059QF0KO0R
Bedside-Care Foam (Alcohol Free)BENZETHONIUM CHLORIDEColoplast Corp3e8a37f0-3b44-4bba-8987-2717b54419f12026-03-30WarningsExact identifier
unii: PH41D05744
Bedside-CareBENZETHONIUM CHLORIDEColoplast Corpe0cf033c-82fa-4b5a-b2be-5b0d13c0cea02026-03-30WarningsExact identifier
unii: PH41D05744
DURMA DynaWound CleanserWOUND CLEANSERDynarex Corporation6a4dd82a-6b06-426b-9afd-415a1a4339b42026-03-23WarningsExact identifier
unii: PH41D05744
Sterile WaterWATERHospira, Inc.2b9ea23a-f9e9-48a8-25b7-519e3bbd68282026-03-18Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
TINTED SUNSCREEN FOUNDATIONTINTED SUNSCREEN FOUNDATIONGuanghzou AiXin Biotech Co Ltd396393c4-b50c-3877-e063-6294a90a0e9b2026-03-17WarningsExact identifier
unii: 059QF0KO0R
Walgreens Sanitizing WipesWALGREENS SANITIZING WIPESWalgreens42de3b25-692b-eaff-e063-6294a90a0d212026-03-11WarningsExact identifier
unii: PH41D05744
Eco Bandage OCEANBENZETHONIUM CHLORIDEECO Bandage LLCc7867df0-e167-4ec6-921b-6a0fb3cb06142026-03-06WarningsExact identifier
unii: PH41D05744
Eco Bandage HONEYBENZETHONIUM CHLORIDEEco Bandage LLCd2faa027-b274-43c0-9b87-85efab89fe8e2026-03-06WarningsExact identifier
unii: PH41D05744
Eco Bandage HIBISCUSBENZETHONIUM CHLORIDEEco Bandage LLC41f8716d-a970-40cd-a29d-69dafc97def82026-03-06WarningsExact identifier
unii: PH41D05744
Eco Bandage MOCHABENZETHONIUM CHLORIDEEco Bandage LLC11ec42e4-49d1-4690-80c3-784f2e30acd32026-03-06WarningsExact identifier
unii: PH41D05744
Eco Bandage SANDBENZETHONIUM CHLORIDEEco Bandage LLC5c620696-e8eb-445e-b746-5348ea37a2142026-03-06WarningsExact identifier
unii: PH41D05744
2-Pack Facial Serum2-PACK FACIAL SERUMGuangzhou Ariel Biotech Co., Ltd.27c7f645-cfb3-6db1-e063-6394a90a42ff2026-03-06WarningsExact identifier
unii: 059QF0KO0R
Benzethonium chloride Plus Dyclonine hydrochlorideLIQUID BANDAGEChain Drug Consortium, LLCd7154398-4f52-434a-b51b-b7829ccebf3b2026-02-12WarningsExact identifier
unii: PH41D05744
Liquid BandageBENZETHONIUM CHLORIDE AND DYCLONINE HYDROCHLORIDEWal-Mart Stores, Inc.f3911d79-3169-71c3-e053-2a95a90ae8432026-01-29WarningsExact identifier
unii: PH41D05744
TriDerma Clean Soothe Bottom WashBOTTOM WASHGenuine Virgin Aloe Corporation498dfc47-e188-6a09-e063-6394a90a4f802026-01-29WarningsExact identifier
unii: PH41D05744

Reported adverse events (FAERS/openFDA)#

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