FDA.reportPublic FDA data

Antibacterial Hand wipes

Product NDC
51628-9999
11-digit product format
516289999
Labeler code
51628
Product ID
51628-9999_3cb4111f-c751-13bf-e063-6394a90a30b5
Type
HUMAN OTC DRUG
Nonproprietary name
Benzalkonium Chloride
Dosage form
CLOTH
Route
TOPICAL
Labeler
MY IMPORTS USA LLC
Application
M003
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-01-15
Substance
BENZALKONIUM CHLORIDE
Active strength
.13 g/100g
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
Antibacterial Hand wipes
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BENZALKONIUM CHLORIDE.13 g/100g

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
2ba77bab-7d02-d7c7-e063-6294a90aae87Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51628-9999-1Antibacterial Hand wipes0.12 g in 1 BAGCLOTH0.125
51628-9999-1Antibacterial Hand wipes25 in 1 CONTAINERCLOTH255
51628-9999-2Antibacterial Hand wipes25 in 1 PAILCLOTH255
51628-9999-2Antibacterial Hand wipes0.12 g in 1 POUCHCLOTH0.125
51628-9999-3Antibacterial Hand wipes80 in 1 PAILCLOTH805
51628-9999-3Antibacterial Hand wipes0.4 g in 1 POUCHCLOTH0.45

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 79 of 114 · 2,275 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Clear DefenseHAND SANITIZING WIPESMelaleuca, Inc.30dec472-8112-37d6-e063-6294a90a1f252025-04-24WarningsExact identifier
application number: M003
Quality Choice Isopropyl Alcohol WipesISOPROPYL ALCOHOLChain Drug Marketing Association, Inc.3347184c-ae72-bec2-e063-6294a90a2d052025-04-23WarningsExact identifier
application number: M003
Dukal Sterile Alcohol Prep PadISOPROPYL ALCOHOLDukal LLC00b2c444-8601-4d8f-b6bb-91b864fd90412025-04-23WarningsExact identifier
application number: M003
PREVENT HAND SANITIZERALCOHOLAMERICAN CHEMICAL AND SANITARY SUPPLY INCee2c3dd2-a82f-4bbf-a288-f0365b9893db2025-04-23WarningsExact identifier
application number: M003
SANIFOAM HAND SANITIZERALCOHOLAMERICAN CHEMICAL AND SANITARY SUPPLY INCe1cfa8ff-92e0-4931-98c9-287c8dcd5a992025-04-23WarningsExact identifier
application number: M003
ANTIBACTERIAL WASH FOAM ITEM 1081CHLOROXYLENOLAMERICAN CHEMICAL AND SANITARY SUPPLY INC18720bd0-6ea8-2d1b-e063-6394a90abe2d2025-04-23WarningsExact identifier
application number: M003
E-2 HAND ITEM 1095CHLOROXYLENOLAMERICAN CHEMICAL AND SANITARY SUPPLY INC18728ebb-c416-5efe-e063-6294a90abd912025-04-23WarningsExact identifier
application number: M003
PEARL ANTIMICROBIAL HAND ITEM 1027AB-01CHLOROXYLENOLAMERICAN CHEMICAL AND SANITARY SUPPLY INC1871b1db-f881-e7fd-e063-6294a90ada982025-04-23WarningsExact identifier
application number: M003
SOFT TOUCH PLUS ANTIBACTERIAL HAND ITEM 1039CHLOROXYLENOLAMERICAN CHEMICAL AND SANITARY SUPPLY INC1870b08e-e5c3-7888-e063-6394a90a1c822025-04-23WarningsExact identifier
application number: M003
SUPER SUDS ANTIBACTERIAL HAND ITEM 1063CHLOROXYLENOLAMERICAN CHEMICAL AND SANITARY SUPPLY INC1871e729-6b76-084e-e063-6394a90a795d2025-04-23WarningsExact identifier
application number: M003
PICKLEBALM LIDOCAINE WITH MENTHOL ARNICA CUCUMBER SEEDLIDOCAINE, MENTHOLCompass Health Brands Corp.2c38a4be-fcbe-9d1d-e063-6294a90a93732025-04-22WarningsExact identifier
application number: M003
Sierra Soft Antibacterial WashCHLOROXYLENOLCWGC LA Inc.49034ae5-be47-4472-a4e5-b5bf633355ed2025-04-21WarningsExact identifier
application number: M003
AplicareHYDROGEN PEROXIDEAplicare Products LLC0b3e5df6-03c8-3880-e063-6394a90a1cdc2025-04-18WarningsExact identifier
application number: M003
Burn CreamBENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDETotal Resources Internationalb971cc41-fe23-4be3-9564-e46d55df1d682025-04-18WarningsExact identifier
application number: M003
Sierra Soft Alcohol Hand SanitizerETHYL ALCOHOLCWGC LA Inc.012463da-94cf-4975-9fa2-6c323855bf572025-04-17WarningsExact identifier
application number: M003
BiopureHAND SANITIZER SPRAYQuest USA Corp323c61fd-adee-393c-e063-6394a90a5eb32025-04-15WarningsExact identifier
application number: M003
BiopureHAND SANITIZER SPRAYQuest USA Corp324b140d-9d43-1c2f-e063-6294a90ae3032025-04-15WarningsExact identifier
application number: M003
Isopropyl alcohol 70 percentISOPROPYL ALCOHOLTARGET Corporation126ec829-c54c-4927-bbd5-a8156d2f6eea2025-04-14WarningsExact identifier
application number: M003
Smart Care Hand Sanitizer AppleALCOHOLShenzhen Lantern Scicence Co.,Ltd.32b88e9f-d3e7-c78c-e063-6294a90a67072025-04-14WarningsExact identifier
application number: M003
Smart Care Hand Sanitizer GingerbreadALCOHOLShenzhen Lantern Scicence Co.,Ltd.3269a702-59a3-af3b-e063-6394a90a97d22025-04-14WarningsExact identifier
application number: M003

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1038558benzalkonium chloride 0.13 % Medicated PadPSN2ba77bab-7d02-d7c7-e063-6294a90aae875
1038558benzalkonium chloride 1.3 MG/ML Medicated PadSCD2ba77bab-7d02-d7c7-e063-6294a90aae875
1038558benzalkonium chloride 0.13 % Topical ClothSY2ba77bab-7d02-d7c7-e063-6294a90aae875
1038558benzalkonium chloride 0.13 % Topical SwabSY2ba77bab-7d02-d7c7-e063-6294a90aae875
1038558benzalkonium chloride 0.13 GM per 100 GM Topical PadSY2ba77bab-7d02-d7c7-e063-6294a90aae875
1038558benzalkonium chloride 0.13 GM per 100 GM Topical SwabSY2ba77bab-7d02-d7c7-e063-6294a90aae875
1038558benzalkonium chloride 1 ML per 750 ML Topical SwabSY2ba77bab-7d02-d7c7-e063-6294a90aae875

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
51628-9999-15162899990125 BAG in 1 CONTAINER (51628-9999-1) / .12 g in 1 BAG25 bag2025-01-15NoNoCurrent
51628-9999-25162899990225 POUCH in 1 PAIL (51628-9999-2) / .12 g in 1 POUCH25 pouch2025-01-15NoNoCurrent
51628-9999-35162899990380 POUCH in 1 PAIL (51628-9999-3) / .4 g in 1 POUCH80 pouch2025-08-18NoNoCurrent