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 25 of 115 · 2,286 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Smart Care Hand Sanitizer 3pk with Leather CaseALCOHOLShenzhen Lantern Scicence Co.,Ltd.4f036ba3-3f21-d04b-e063-6294a90ad7d72026-04-09WarningsExact identifier
application number: M003
Smart Care Hand Sanitizer Pistachio CremeALCOHOLShenzhen Lantern Scicence Co.,Ltd.4eeedd3e-d4b4-9967-e063-6394a90abf332026-04-08WarningsExact identifier
application number: M003
Smart Care Hand Sanitizer French VanillaALCOHOLShenzhen Lantern Scicence Co.,Ltd.4eef33c2-695a-3a32-e063-6394a90a0a7b2026-04-08WarningsExact identifier
application number: M003
Smart Care Licensed Hand Sanitizer Squishmallows PinkALCOHOLShenzhen Lantern Scicence Co.,Ltd.4eefc5bc-7dd4-e4c8-e063-6394a90a9a512026-04-08WarningsExact identifier
application number: M003
Verifine Alcohol SwabsALCOHOL SWABSPromisemed Hangzhou Meditech Co.,LTD.4ef56b6c-ad46-2d02-e063-6294a90ad4072026-04-08WarningsExact identifier
application number: M003
RubbingETHYL ALCOHOLPerrigo Direct, Incba2266d7-da25-495a-b035-97e149551c302026-04-08Warnings, Adverse reactionsExact identifier
application number: M003
Smart Care Licensed Hand Sanitizer Squishmallows PurpleALCOHOLShenzhen Lantern Scicence Co.,Ltd.4efeb523-0a73-2e48-e063-6394a90aac5e2026-04-08WarningsExact identifier
application number: M003
Smart Care Licensed Hand Sanitizer Hot Wheels RedALCOHOLShenzhen Lantern Scicence Co.,Ltd.4efefd07-c1df-695a-e063-6294a90a51eb2026-04-08WarningsExact identifier
application number: M003
Smart Care Licensed Hand Sanitizer Hot Wheels PurpleALCOHOLShenzhen Lantern Scicence Co.,Ltd.4eff601c-7bcd-1ddd-e063-6294a90a80402026-04-08WarningsExact identifier
application number: M003
Smart Care Hand Sanitizer Ocean BreezeALCOHOLShenzhen Lantern Scicence Co.,Ltd.4effb28e-fa83-5a06-e063-6394a90aa2f52026-04-08WarningsExact identifier
application number: M003
70%ISOPROPYL ALCOHOLPerrigo Direct, Incf953a249-07ad-40a1-8aea-b2d419fd3d4d2026-04-07Warnings, Adverse reactionsExact identifier
application number: M003
50% RubbingISOPROPYL ALCOHOLPerrigo Direct, Inc698bede7-4fc1-4e85-8ac4-d735f409cfae2026-04-06Warnings, Adverse reactionsExact identifier
application number: M003
Ethyl Rubbing AlcoholETHYL ALCOHOLAmazon.com Services LLC5369424a-ccbd-4dc6-af6b-7876484a9fe62026-04-06Warnings, Adverse reactionsExact identifier
application number: M003
Caring Mill Triple Hand Sanitizer with LavenderETHYL ALCOHOLFSA Store Inc. (Caring Mills)4b0b5436-a1ce-cfa6-e063-6394a90a2efe2026-04-04WarningsExact identifier
application number: M003
Smart Care Hand Sanitizer Passion ParadiseALCOHOLShenzhen Lantern Scicence Co.,Ltd.4e850ea9-0999-12b4-e063-6394a90af4062026-04-02WarningsExact identifier
application number: M003
Smart Care Hand Sanitizer Tropical MangoALCOHOLShenzhen Lantern Scicence Co.,Ltd.4e85630a-6d18-e6a4-e063-6394a90a1d122026-04-02WarningsExact identifier
application number: M003
Smart Care Hand Sanitizer Coco CabanaALCOHOLShenzhen Lantern Scicence Co.,Ltd.4e85923b-6b8c-f9a2-e063-6294a90a0d8e2026-04-02WarningsExact identifier
application number: M003
Smart Care Hand Sanitizer Sea BreezeALCOHOLShenzhen Lantern Scicence Co.,Ltd.4e85e279-7751-8bd7-e063-6294a90a095b2026-04-02WarningsExact identifier
application number: M003
Povidone Iodine 10%POVIDONE IODINEFarmacias De Similares TX LLC4e6baed0-ea31-79e2-e063-6294a90a3bb12026-04-01WarningsExact identifier
application number: M003
FRESH LINES SANITIZERALCOHOL ANTISEPTICKingkey MBC Life Technology Group Co.,Ltd5005d615-d9c3-a46d-e063-6394a90af88a2026-04-01WarningsExact 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