FDA.reportPublic FDA data

Hand Sanitizer plus Holder

Product NDC
78164-101
11-digit product format
781640101
Labeler code
78164
Product ID
78164-101_3f042aa7-7546-a06c-e063-6394a90aed31
Type
HUMAN OTC DRUG
Nonproprietary name
Benzalkonium Chloride
Dosage form
LIQUID
Route
TOPICAL
Labeler
Gertex Hosiery
Application
M003
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-09-01
Substance
BENZALKONIUM CHLORIDE
Active strength
.1 g/mL
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
Hand Sanitizer plus Holder
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BENZALKONIUM CHLORIDE.1 g/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
a182eafa-0ce0-4b99-bcb0-23f9a8de9e1fAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
78164-101-35Hand Sanitizer plus Holder35 mL in 1 BOTTLELIQUID351

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
78164-101-357816401013535 mL in 1 BOTTLE (78164-101-35) 35 ml2025-09-01NoNoCurrent