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 9 of 115 · 2,286 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MISTIFY WATERMELON HYDRATING HAND SANITIZERALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd574bf021-6352-e3fc-e063-6394a90ad6de2026-07-23WarningsExact identifier
application number: M003
FRESH THEORY ANTIBACTERIAL HAND WIPES - Vanilla, Strawberry, FreshBENZALKONIUM CHLORIDEQuest USA Corp5719809b-1c74-4bf3-e063-6294a90ab0082026-07-23WarningsExact identifier
application number: M003
First Aid AntisepticPOVIDONE-IODINE 5%Walgreen Company262ea2c8-f571-1c0b-e063-6394a90af20b2026-07-22WarningsExact identifier
application number: M003
Verifine Alcohol SwabsALCOHOL SWABSPromisemed Hangzhou Meditech Co.,LTD.5738a502-c5ab-21b0-e063-6294a90a20a72026-07-22WarningsExact identifier
application number: M003
KeepGoing Sting Relief PadBENZOCAINE AND ISOPROPYL ALCOHOLJ&A Digital Inc.a630db1b-1674-4659-a60f-56994b0a15642026-07-22WarningsExact identifier
application number: M003
KeepGoing Alcohol Prep PadISOPROPYL ALCOHOLJ&A Digital Inc.5d1e776b-4027-4d05-b02f-8a2701d7bc7a2026-07-22WarningsExact identifier
application number: M003
KeepGoing Non Sting Cleaning WipeBENZALKONIUM CHLORIDEJ&A Digital Inc.1a6303ce-8df7-4e8b-93f2-e162fdd2540c2026-07-22WarningsExact identifier
application number: M003
Lights Povidone Iodine SwabsticksPOVIDONE-IODINELights Medical Manufacture Co., Ltd.664bbf9f-650a-45fd-b9b8-d93f0ba631902026-07-22WarningsExact identifier
application number: M003
DOCTOR INKS TOPICAL ANTISEPTICBENZALKONIUM CHLORIDEEnviro Specialty Chemicals Incd503a2db-e326-4a31-bc6a-5034ad74bf0b2026-07-21WarningsExact identifier
application number: M003
MY-SHIELD TOPICAL ANTISEPTICBENZALKONIUM CHLORIDEEnviro Specialty Chemicals Incc2c1f5d9-cd6e-4314-9dfc-961ed877c2932026-07-21WarningsExact identifier
application number: M003
Germ Free Topical AntisepticBENZALKONIUM CHLORIDEEnviro Specialty Chemicals Inc5e004412-1797-4cbf-83e3-7001286ad1572026-07-21WarningsExact identifier
application number: M003
Midnight Magic Hand SanitizerALCOHOLScent Theory Products LLC5721d186-ec6d-fa26-e063-6294a90a76d22026-07-21WarningsExact identifier
application number: M003
McKesson PVP Prep SolutionPOVIDONE-IODINEMcKesson Medical-Surgical33fa233c-b43c-42d8-af37-a58f098a0d512026-07-21WarningsExact identifier
application number: M003
Twisted Caramel Apple Hand SanitizerALCOHOLScent Theory Products LLC572a82e3-93ec-9af4-e063-6294a90a9c262026-07-21WarningsExact identifier
application number: M003
Molten Marshmallow Hand SanitizerALCOHOLScent Theory Products LLC572aa67e-52f7-b424-e063-6394a90ac4ae2026-07-21WarningsExact identifier
application number: M003
FRESH THEORY ANTIBACTERIAL HAND WIPES FRESH AND FRUITYBENZALKONIUM CHLORIDEQuest USA Corp57135b3f-884d-1a03-e063-6294a90ae3e92026-07-20WarningsExact identifier
application number: M003
FRESH THEORY ANTIBACTERIAL HAND WIPES - PEACH PROSECCOBENZALKONIUM CHLORIDEQuest USA Corp571709fb-ca50-f7b1-e063-6394a90a8d352026-07-20WarningsExact identifier
application number: M003
FRESH THEORY ANTIBACTERIAL HAND WIPES - TROPICAL ESCAPEBENZALKONIUM CHLORIDEQuest USA Corp57180e7a-1134-9ecd-e063-6294a90af5bf2026-07-20WarningsExact identifier
application number: M003
Biopure 70% Isopropyl Alcohol WipeISOPROPYL ALCOHOL, WIPEQUEST USA CORP3a7932c4-6f90-a008-e063-6294a90aa7692026-07-19WarningsExact identifier
application number: M003
Urgent First Aid BZK Antiseptic WipeBENZALKONIUM CHLORIDEChangzhou Maokang Medical Products Co., Ltd5701c813-4346-a727-e063-6294a90a8e052026-07-19WarningsExact 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