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 24 of 115 · 2,286 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Scriptsusa Hand SanitizerALCOHOLEnergized Solution Corp4f97edd9-717a-315b-e063-6394a90aade72026-04-27WarningsExact identifier
application number: M003
Tigerherbs Natural Healing CreamBEDSORE CREAMShenzhen Yao Yu Technology Co., LTD392c3666-b86e-9266-e063-6394a90ae5022026-04-25WarningsExact identifier
application number: M003
MISTIFY WHIPPED STRAWBERRY HYDRATING HAND SANITISERALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd5006097e-16e6-d180-e063-6394a90ae0c22026-04-22WarningsExact identifier
application number: M003
Sanitizing Wipes LavenderALCOHOLThe Honest Company Inc.4a69b1d5-81ad-2cd1-e063-6294a90ac62d2026-04-22WarningsExact identifier
application number: M003
Sanitizing Wipes GrapefruitALCOHOLThe Honest Company Inc.4aa8c899-e5c3-9eec-e063-6294a90a6eae2026-04-22WarningsExact identifier
application number: M003
3M Skin and Nasal AntisepticPOVIDONE-IODINESolventum US LLC1a94494d-7dd3-4f32-bc42-81c199fe233e2026-04-22WarningsExact identifier
application number: M003
3M Avagard DALCOHOLSolventum US LLC220c8a49-2a52-4660-8ad4-de553bd032262026-04-22WarningsExact identifier
application number: M003
Santa and Friends Hand Sanitizers Santa Cookies, Caramel Vanilla Snuggle, Frosted Marshmallow, Winterberry CrumbleALCOHOL SPRAYScent Theory Products LLC4ffa6e26-870f-586e-e063-6394a90ad9752026-04-21WarningsExact identifier
application number: M003
BIOPURE 50CT ANTI BACTERIAL HAND WIPESBENZALKONIUM CHLORIDEZhejiang Furuisen Spunlaced Nonwovens Co., Ltd.4fcf2c05-9bd2-2813-e063-6294a90a44012026-04-19WarningsExact identifier
application number: M003
Solar Flare Sunlit Holiday Hand Sanitizers (Golden Caramel, Vanilla Solstice, Amber Rose)ALCOHOL SPRAYScent Theory Products LLC4fc170dd-7c6b-b810-e063-6394a90ae61f2026-04-18WarningsExact identifier
application number: M003
Megababe - Squeaky Clean Hand SanitizerETHYL ALCOHOLMEGABABE, LLC249e00ef-fe9d-dc07-e063-6394a90a9f4c2026-04-16WarningsExact identifier
application number: M003
Burn CreamBENZALKONIUM CHLORIDE, LIDOCAINE HCIProstat First Aid4f9adbac-5497-e7be-e063-6294a90a75182026-04-16WarningsExact identifier
application number: M003
Megababe - Squeaky Clean Hand SanitizerETHYL ALCOHOLMEGABABE, LLC2d940d35-6a73-e494-e063-6394a90a9d162026-04-14WarningsExact identifier
application number: M003
Freskaro Povidone IodinePOVIDONE IODINE 10%Pharma Nobis, LLC4f711d3b-5ed6-5dd4-e063-6294a90afeaa2026-04-14WarningsExact identifier
application number: M003
Isopropyl AlcoholISOPROPYL ALCOHOLPerrigo Direct, Incec43a3f5-c5f3-439b-8764-ca92fefb45c92026-04-10Warnings, Adverse reactionsExact identifier
application number: M003
Hydrogen PeroxideHYDROGEN PEROXIDEWalmart Inc.ebd02cd3-75cc-444b-8284-d28733a2855b2026-04-10Warnings, Adverse reactionsExact identifier
application number: M003
Isopropyl AlcoholISOPROPYL ALCOHOLMSC Industrial Supplyb248ad4a-ed92-4d03-b0da-9639c46e19492026-04-10Warnings, Adverse reactionsExact identifier
application number: M003
Smart Care Hand Sanitizer Sunset GuavaALCOHOLShenzhen Lantern Scicence Co.,Ltd.4f01fc3a-5b01-4b6b-e063-6294a90aefb42026-04-09WarningsExact identifier
application number: M003
Smart Care Hand Sanitizer Fresh RainALCOHOLShenzhen Lantern Scicence Co.,Ltd.4f02adaa-1440-5778-e063-6294a90a344a2026-04-09WarningsExact identifier
application number: M003
Smart Care Hand Sanitizer Watermelon WaveALCOHOLShenzhen Lantern Scicence Co.,Ltd.4f031f62-e56c-9063-e063-6394a90af9c12026-04-09WarningsExact 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