FDA.reportPublic FDA data

BIOPURE 50CT ANTI BACTERIAL HAND WIPES

Product NDC
79794-800
11-digit product format
797940800
Labeler code
79794
Product ID
79794-800_400f215e-b012-c880-e063-6394a90ad5c5
Type
HUMAN OTC DRUG
Nonproprietary name
Benzalkonium Chloride
Dosage form
CLOTH
Route
TOPICAL
Labeler
Zhejiang Furuisen Spunlaced Nonwovens Co., Ltd.
Application
M003
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-11-25
Substance
BENZALKONIUM CHLORIDE
Active strength
.13 g/1001
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
BIOPURE 50CT ANTI BACTERIAL HAND WIPES
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BENZALKONIUM CHLORIDE.13 g/1001

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
F5UM2KM3W7Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1038558Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
ee484505-3bb1-2989-e053-2995a90aea2bAvailable on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
79794-800-012024-02-01C16284748780-11030e365-632c-111a-e063-dadaa90a10e279794-800

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
79794-800-01BIOPURE 50CT ANTI BACTERIAL HAND WIPES1 in 1 BOXCLOTH18
79794-800-01BIOPURE 50CT ANTI BACTERIAL HAND WIPES12 in 1 CANISTERCLOTH128
79794-800-02BIOPURE 50CT ANTI BACTERIAL HAND WIPES1 in 1 BOXCLOTH18
79794-800-02BIOPURE 50CT ANTI BACTERIAL HAND WIPES12 in 1 CANISTERCLOTH128
79794-800-03BIOPURE 50CT ANTI BACTERIAL HAND WIPES12 in 1 CANISTERCLOTH128
79794-800-03BIOPURE 50CT ANTI BACTERIAL HAND WIPES1 in 1 BOXCLOTH18
79794-800-04BIOPURE 50CT ANTI BACTERIAL HAND WIPES1 in 1 BOXCLOTH18
79794-800-04BIOPURE 50CT ANTI BACTERIAL HAND WIPES12 in 1 CANISTERCLOTH128
79794-800-05BIOPURE 50CT ANTI BACTERIAL HAND WIPES1 in 1 CARTONCLOTH18
79794-800-05BIOPURE 50CT ANTI BACTERIAL HAND WIPES12 in 1 CANISTERCLOTH128
79794-800-06BIOPURE 50CT ANTI BACTERIAL HAND WIPES1 in 1 CARTONCLOTH18
79794-800-06BIOPURE 50CT ANTI BACTERIAL HAND WIPES12 in 1 CANISTERCLOTH128
79794-800-07BIOPURE 50CT ANTI BACTERIAL HAND WIPES20 in 1 CANISTERCLOTH208
79794-800-07BIOPURE 50CT ANTI BACTERIAL HAND WIPES24 in 1 CARTONCLOTH248
79794-800-08BIOPURE 50CT ANTI BACTERIAL HAND WIPES75 in 1 CANISTERCLOTH758
79794-800-08BIOPURE 50CT ANTI BACTERIAL HAND WIPES12 in 1 CARTONCLOTH128
79794-800-09BIOPURE 50CT ANTI BACTERIAL HAND WIPES20 in 1 CANISTERCLOTH208
79794-800-09BIOPURE 50CT ANTI BACTERIAL HAND WIPES24 in 1 CARTONCLOTH248
79794-800-10BIOPURE 50CT ANTI BACTERIAL HAND WIPES12 in 1 CARTONCLOTH128
79794-800-10BIOPURE 50CT ANTI BACTERIAL HAND WIPES75 in 1 CANISTERCLOTH758
79794-800-11BIOPURE 50CT ANTI BACTERIAL HAND WIPES24 in 1 CARTONCLOTH248
79794-800-11BIOPURE 50CT ANTI BACTERIAL HAND WIPES20 in 1 CANISTERCLOTH208

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
79794-800BIOPURE 50CT ANTI BACTERIAL HAND WIPES (BENZALKONIUM CHLORIDE) CLOTH [ZHEJIANG FURUISEN SPUNLACED NONWOVENS CO., LTD.]6Current NDC, Legacy NDC, 22 package rows20241120_ee484505-3bb1-2989-e053-2995a90aea2b.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 112 of 115 · 2,286 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Septihol Hand SanitizerALCOHOLSTERIS Corporation279c5c6f-bf45-499f-a5a2-ddb5353821462023-12-06WarningsExact identifier
application number: M003
Zany Antiseptic GelALCOHOLLaboratorios Zepol S.A.ee085cb5-0ebf-498c-b622-b2c29d34bb9b2023-12-01WarningsExact identifier
application number: M003
Prep Pad SterilePOVIDONE-IODINEChangzhou Maokang Medical Products Co., Ltd758abf53-ad8a-62ac-e053-2991aa0a8f0c2023-11-15WarningsExact identifier
application number: M003
FIRSTAR Alcohol Prep PadISOPROPYL ALCOHOLJIANGMEN SHUIZIRUN SANITARY ARTICLES CO., LTD.49a86020-b888-423f-99a5-02fa938105ec2023-11-15WarningsExact identifier
application number: M003
CVS Health Isopropyl Rubbing AlcoholISOPROPYL ALCOHOLCVS Health4678074a-16f1-5480-e054-00144ff8d46c2023-11-10WarningsExact identifier
application number: M003
Care One 70 Isopropyl Alcohol WipesISOPROPYL ALCOHOLAhold U.S.A., Inc.607b6917-2880-4b1c-83c6-f1297a828ecc2023-11-10WarningsExact identifier
application number: M003
Topcare 3 Hydrogen Peroxide WipesHYDROGEN PEROXIDETopco Associates LLCdc4b07b6-6476-4e32-901a-da8115d6a1972023-11-10WarningsExact identifier
application number: M003
Topcare 70 Isopropyl Alcohol WipesISOPROPYL ALCOHOLTopco Associates LLCbf9ee7da-69d9-47a2-8748-6b978ca3c2982023-11-10WarningsExact identifier
application number: M003
MK Alcohol Swabstick SterileISOPROPYL ALCOHOLChangzhou Maokang Medical Products Co., Ltd40c7cfc6-ef3b-4759-b9e9-6d7e1319a8472023-11-09WarningsExact identifier
application number: M003
BZK Antiseptic WipeBENZALKONIUM CHLORIDEChangzhou Maokang Medical Products Co., Ltdfe5eb694-4b1b-4c47-95d5-6074155c438a2023-11-09WarningsExact identifier
application number: M003
Leader Alcohol 70 Isopropyl AlcoholISOPROPYL ALCOHOLCardinal Health4b5d50cb-a8b4-4997-a8dd-26506c4cdc6d2023-11-09WarningsExact identifier
application number: M003
BZK Cleansing Swabsticks 4 TripleBENZALKONIUM CHLORIDEChangzhou Maokang Medical Products Co., Ltd52c74f75-d7ef-481b-b580-fba402d03d752023-11-09WarningsExact identifier
application number: M003
MK Alcohol Swabstick SterileISOPROPYL ALCOHOLChangzhou Maokang Medical Products Co., Ltd48d198f0-d505-4e45-b7c9-dd70658fd5fa2023-11-09WarningsExact identifier
application number: M003
Maokang 3 Hydrogen PeroxideHYDROGEN PEROXIDEChangzhou Maokang Medical Products Co., Ltdb4b478b9-426d-4864-a64c-31de9bbf5dc32023-11-09WarningsExact identifier
application number: M003
MK Sting Relief PadsBENZOCAINE, ISOPROPYL ALCOHOLChangzhou Maokang Medical Products Co., Ltd1a60dd1b-0116-42a2-a501-4f74e326a2e92023-11-09WarningsExact identifier
application number: M003
terrasil First Aid Antiseptic Wound and Burn Care KitHEXYLRESORCINOLAidance Scientific, Inc, DBA Aidance Skincare & Topical Solutions5ddb84e9-cdf7-4034-acd2-625f8d6e46012023-11-08WarningsExact identifier
application number: M003
Inverness Ear PiercingBENZALKONIUM CHLORIDEThe Richline Group, Inc.bcec8099-939b-4cff-b388-f4046164f2d42023-11-08WarningsExact identifier
application number: M003
Hygienic Ear Care AntisepticBENZALKONIUM CHLORIDEThe Richline Group, Inc.98b70f22-cd53-e61b-e053-2995a90a730d2023-11-06WarningsExact identifier
application number: M003
ISOPROPYL ALCOHOLISOPROPYL ALCOHOLDegasa, S.A. de C.V.b4145aa4-d810-4c20-8493-311a7e222eb92023-11-05WarningsExact identifier
application number: M003
HYDROGEN PEROXIDEHYDROGEN PEROXIDEDEGASA SA DE CV26bae595-6e76-4946-b98f-1aba2e69250d2023-11-05WarningsExact identifier
application number: M003

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1038558benzalkonium chloride 0.13 % Medicated PadPSNee484505-3bb1-2989-e053-2995a90aea2b8
1038558benzalkonium chloride 1.3 MG/ML Medicated PadSCDee484505-3bb1-2989-e053-2995a90aea2b8
1038558benzalkonium chloride 0.13 % Topical ClothSYee484505-3bb1-2989-e053-2995a90aea2b8
1038558benzalkonium chloride 0.13 % Topical SwabSYee484505-3bb1-2989-e053-2995a90aea2b8
1038558benzalkonium chloride 0.13 GM per 100 GM Topical PadSYee484505-3bb1-2989-e053-2995a90aea2b8
1038558benzalkonium chloride 0.13 GM per 100 GM Topical SwabSYee484505-3bb1-2989-e053-2995a90aea2b8
1038558benzalkonium chloride 1 ML per 750 ML Topical SwabSYee484505-3bb1-2989-e053-2995a90aea2b8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
79794-800-01797940800011 CANISTER in 1 BOX (79794-800-01) / 12 PATCH in 1 CANISTER / 50 CLOTH in 1 PATCH1 canister2022-11-250000-00-00NoNoCurrent
79794-800-02797940800021 CANISTER in 1 BOX (79794-800-02) / 12 PATCH in 1 CANISTER / 50 CLOTH in 1 PATCH1 canister2024-03-01NoNoCurrent
79794-800-03797940800031 CANISTER in 1 BOX (79794-800-03) / 12 PATCH in 1 CANISTER / 50 CLOTH in 1 PATCH1 canister2024-03-01NoNoCurrent
79794-800-04797940800041 CANISTER in 1 BOX (79794-800-04) / 12 PATCH in 1 CANISTER / 60 CLOTH in 1 PATCH1 canister2024-03-01NoNoCurrent
79794-800-05797940800051 CANISTER in 1 CARTON (79794-800-05) / 12 PATCH in 1 CANISTER / 50 CLOTH in 1 PATCH1 canister2024-05-09NoNoCurrent
79794-800-06797940800061 CANISTER in 1 CARTON (79794-800-06) / 12 PATCH in 1 CANISTER / 50 CLOTH in 1 PATCH1 canister2024-05-09NoNoCurrent
79794-800-077979408000724 CANISTER in 1 CARTON (79794-800-07) / 20 PATCH in 1 CANISTER / 1 CLOTH in 1 PATCH24 canister2024-05-09NoNoCurrent
79794-800-087979408000812 CANISTER in 1 CARTON (79794-800-08) / 75 PATCH in 1 CANISTER / 1 CLOTH in 1 PATCH12 canister2024-11-01NoNoCurrent
79794-800-097979408000924 CANISTER in 1 CARTON (79794-800-09) / 20 PATCH in 1 CANISTER / 1 CLOTH in 1 PATCH24 canister2024-05-09NoNoCurrent
79794-800-107979408001012 CANISTER in 1 CARTON (79794-800-10) / 75 PATCH in 1 CANISTER / 1 CLOTH in 1 PATCH12 canister2024-11-01NoNoCurrent
79794-800-117979408001124 CANISTER in 1 CARTON (79794-800-11) / 20 PATCH in 1 CANISTER / 1 CLOTH in 1 PATCH24 canister2025-09-30NoNoCurrent