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 41 of 115 · 2,286 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Benzalkonium ChlorideSANITIZING HAND WIPESALO NEW YORK LLCd3afde78-b9f6-3648-e053-2a95a90a40242026-01-15WarningsExact identifier
application number: M003
BIOPURE Hand Sanitizer Spray-Coastal GlowHAND SANITIZER SPRAYQuest USA Corp48254577-9f1e-9389-e063-6394a90a92f12026-01-15WarningsExact identifier
application number: M003
hi peach layneETHYL ALCOHOLZhejiang Jinghui Cosmetics Share Co., Ltd.487a4c8e-4fb3-6bff-e063-6294a90abd532026-01-15WarningsExact identifier
application number: M003
Gold Bond Hydrating Hand SanitizerETHYL ALCOHOLChattem, Inc.96fe0191-0d34-4bf3-8f93-0e64764c353a2026-01-14WarningsExact identifier
application number: M003
Alcohol Prep AwabsISOPROPYL ALCOHOLEnlightening Pallet Industry Co., Limited26c7db1e-86a9-8765-e063-6294a90a634f2026-01-14WarningsExact identifier
application number: M003
Caring HandsHAND MOISTURIZING SANITIZERGleeco Labs LLC2ced5dc5-47dd-1b71-e063-6394a90a0e3d2026-01-14WarningsExact identifier
application number: M003
Isopropyl Rubbing AlcoholISOPROPYL ALCOHOLDealMed Medical Supplies LLC04e6edb5-07ef-4ed4-ba68-ed183386b5ab2026-01-13WarningsExact identifier
application number: M003
Dermoplast First AidBENZETHONIUM CHLORIDE AND BENZOCAINEAdvantice Health, LLCec93011d-7069-4021-8dd2-3d51eb6026e12026-01-13WarningsExact identifier
application number: M003
WISH ISOPROPYL ALCOHOLWISH ISOPROPYL ALCOHOLClick Products LLC484befce-ecfe-5514-e063-6294a90a169c2026-01-13WarningsExact identifier
application number: M003
WISH RUBBING ALCOHOL 32ozWISH RUBBING ALCOHOL 32OZ 70%CLICK PRODUCTS LLC4836b564-0b8c-2fb4-e063-6394a90a9c4a2026-01-13WarningsExact identifier
application number: M003
Hydrogen PeroxideHYDROGEN PEROXIDEDealMed Medical Supplies LLC6d1ddf10-8873-4781-9165-bb1c4bbccfc92026-01-13WarningsExact identifier
application number: M003
AVANCE INCONTINENCE CAREBENZETHONIUM CHLORIDESMART CHOICE MEDICAL INC.e2c51699-d4da-5b88-e053-2995a90afd7f2026-01-12WarningsExact identifier
application number: M003
AVANCE INCONTINENCE CAREBENZETHONIUM CHLORIDESMART CHOICE MEDICAL INC.e297b705-8070-f7c3-e053-2a95a90a8c5b2026-01-12WarningsExact identifier
application number: M003
Hydrogen PeroxideHYDROGEN PEROXIDEHydrox Laboratories6e5709b4-cc56-4768-b704-1d9b0e3efec72026-01-12WarningsExact identifier
application number: M003
Isopropyl Alcohol 50%ISOPROPYL ALCOHOL 50%Hydrox Laboratories930bb3a3-5ca3-414c-b4fb-c71ee17fc7462026-01-12WarningsExact identifier
application number: M003
Povidone IodinePOVIDONE-IODINESion Biotext Medical Ltd04438f9e-302c-431b-b3ad-d2c50ca01ad82026-01-12WarningsExact identifier
application number: M003
Isopropyl AlcoholISOPROPYL ALCOHOLHydrox Laboratoriesf2f07464-6bd5-434c-8dea-0ba659c0e5492026-01-12WarningsExact identifier
application number: M003
Isopropyl Alcohol with Wintergreen 70%ISOPROPYL ALCOHOL WITH WINTERGREEN 70%Hydrox Laboratories5845f723-8866-4738-bec6-621041899f572026-01-12WarningsExact identifier
application number: M003
Isopropyl AlcoholISOPROPYL ALCOHOLHydrox Laboratories2042cf29-52c5-4f1e-aae6-78e025994d182026-01-12WarningsExact identifier
application number: M003
Isopropyl Alcohol with Wintergreen 50%ISOPROPYL ALCOHOL WITH WINTERGREEN 50%Hydrox Laboratories3a15a900-2b48-487f-b252-a1a1e0d0abfc2026-01-12WarningsExact 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