FDA.reportPublic FDA data

KLEENEX Foam Hand Sanitizer

Product NDC
55118-701
11-digit product format
551180701
Labeler code
55118
Product ID
55118-701_30f0ed99-94db-4881-8061-ec3b50c62b64
Type
HUMAN OTC DRUG
Nonproprietary name
Benzalkonium Chloride
Dosage form
SOLUTION
Route
TOPICAL
Labeler
Kimberly-Clark
Application
M003
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2015-09-01
Substance
BENZALKONIUM CHLORIDE
Active strength
1.3 mg/1000mL
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage55118-70155118-701-10DDiscontinued by firm2026-10-21
excluded packagepackage55118-70155118-701-12DDiscontinued by firm2026-10-21
excluded packagepackage55118-70155118-701-99DDiscontinued by firm2026-10-21

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
KLEENEX Foam Hand Sanitizer
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BENZALKONIUM CHLORIDE1.3 mg/1000mL

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
1fa77ae2-b652-463d-8943-d338c591226eAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55118-701-10KLEENEX Foam Hand Sanitizer1000 mL in 1 CARTRIDGESOLUTION10008
55118-701-11KLEENEX Foam Hand Sanitizer45 mL in 1 BOTTLE, PUMPSOLUTION458
55118-701-12KLEENEX Foam Hand Sanitizer1200 mL in 1 CARTRIDGESOLUTION12008
55118-701-18KLEENEX Foam Hand Sanitizer532 mL in 1 BOTTLE, PUMPSOLUTION5328
55118-701-64KLEENEX Foam Hand Sanitizer24 in 1 CARTONSOLUTION248
55118-701-67KLEENEX Foam Hand Sanitizer4 in 1 CARTONSOLUTION48
55118-701-99KLEENEX Foam Hand Sanitizer473 mL in 1 BOTTLE, PUMPSOLUTION4738

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Benzalkonium ChlorideACTIVE INGREDIENTF5UM2KM3W7KLEENEX FOAM HAND SANITIZER (BENZALKONIUM CHLORIDE) SOLUTION [KIMBERLY-CLARK CORPORATION]1
BenzalkoniumACTIVE MOIETY7N6JUD5X6YKLEENEX FOAM HAND SANITIZER (BENZALKONIUM CHLORIDE) SOLUTION [KIMBERLY-CLARK CORPORATION]1
AloeINACTIVE INGREDIENTV5VD430YW9KLEENEX FOAM HAND SANITIZER (BENZALKONIUM CHLORIDE) SOLUTION [KIMBERLY-CLARK CORPORATION]1
CalciumINACTIVE INGREDIENTSY7Q814VUPKLEENEX FOAM HAND SANITIZER (BENZALKONIUM CHLORIDE) SOLUTION [KIMBERLY-CLARK CORPORATION]1
Citric Acid MonohydrateINACTIVE INGREDIENT2968PHW8QPKLEENEX FOAM HAND SANITIZER (BENZALKONIUM CHLORIDE) SOLUTION [KIMBERLY-CLARK CORPORATION]1
Cocamidopropyl Propylene Glycol-Dimonium Chloride PhosphateINACTIVE INGREDIENTH2KVQ74JM4KLEENEX FOAM HAND SANITIZER (BENZALKONIUM CHLORIDE) SOLUTION [KIMBERLY-CLARK CORPORATION]1
MethylpropanediolINACTIVE INGREDIENTN8F53B3R4RKLEENEX FOAM HAND SANITIZER (BENZALKONIUM CHLORIDE) SOLUTION [KIMBERLY-CLARK CORPORATION]1
PanthenolINACTIVE INGREDIENTWV9CM0O67ZKLEENEX FOAM HAND SANITIZER (BENZALKONIUM CHLORIDE) SOLUTION [KIMBERLY-CLARK CORPORATION]1
Polyethylene Oxide 600000INACTIVE INGREDIENT2126FD486LKLEENEX FOAM HAND SANITIZER (BENZALKONIUM CHLORIDE) SOLUTION [KIMBERLY-CLARK CORPORATION]1
Silicon DioxideINACTIVE INGREDIENTETJ7Z6XBU4KLEENEX FOAM HAND SANITIZER (BENZALKONIUM CHLORIDE) SOLUTION [KIMBERLY-CLARK CORPORATION]1
Sodium HydroxideINACTIVE INGREDIENT55X04QC32IKLEENEX FOAM HAND SANITIZER (BENZALKONIUM CHLORIDE) SOLUTION [KIMBERLY-CLARK CORPORATION]1
WaterINACTIVE INGREDIENT059QF0KO0RKLEENEX FOAM HAND SANITIZER (BENZALKONIUM CHLORIDE) SOLUTION [KIMBERLY-CLARK CORPORATION]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55118-701KLEENEX FOAM HAND SANITIZER (BENZALKONIUM CHLORIDE) SOLUTION [KIMBERLY-CLARK]6Current NDC, Legacy NDC, 7 package rows20241215_1fa77ae2-b652-463d-8943-d338c591226e.zip

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 11 of 115 · 2,286 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Humco Gentian Violet 2%GENTIAN VIOLET 2%Humco Holding Group, Inc.a07f61e5-0215-419a-a68a-1d814417c35f2026-07-09WarningsExact identifier
application number: M003
GNP Gentian Violet 1%GENTIAN VIOLET 1%Amerrisource Bergen5d07274f-e848-6c60-e053-2991aa0a40d82026-07-09WarningsExact identifier
application number: M003
Drs pharmacy triple antibiotic Pain plus itch plus ScarBACITRACIN ZINC, POLYMYXIN B SULFATE, NEOMYCIN SULFATE OINTMENTOL PHARMA TECH, LLC16273878-2f58-0d26-e063-6394a90a47d22026-07-09WarningsExact identifier
application number: M003
Drs. Pharmacy Triple Antibiotic Plus Pain reliefBACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, LIDOCAINEOL PHARMA TECH, LLC Drs PHARMACY1626fa89-cec0-6467-e063-6294a90aa2a42026-07-09WarningsExact identifier
application number: M003
Ashley Belle 1 oz., Moisturizing Hand Sanitizing, Tropical MangoETHYL ALCOHOL 70% V/VMY IMPORTS USA LLC56148c12-7d6f-26bf-e063-6294a90a93df2026-07-08WarningsExact identifier
application number: M003
Povidone-IodinePOVIDONE-IODINECARDINAL HEALTH 110, LLC. DBA LEADER4f0d8da5-a75b-acc7-e063-6394a90ae8392026-07-08WarningsExact identifier
application number: M003
Ashley Belle 1 oz., Moisturizing Hand Sanitizing, Tropical MangoETHYL ALCOHOL 70% V/VZhejiang Guoyao Jingyue Aerosol Co., Ltd.5600cf8a-5aba-1a22-e063-6394a90a80832026-07-07WarningsExact identifier
application number: M003
Ashley Belle 1 oz., Moisturizing Hand Sanitizing, Pink SugarETHYL ALCOHOL 70% V/VMY IMPORTS USA LLC5600dc30-192d-19b1-e063-6394a90a66d32026-07-07WarningsExact identifier
application number: M003
70%ISOPROPYL ALCOHOLSave-A-Lot Food Stores Ltda592326c-c062-4ebf-b8dd-83f7e6f2f22b2026-07-07Warnings, Adverse reactionsExact identifier
application number: M003
Amazon Basics Citrus Scent Antibacterial Hand WipesBENZALKONIUM CHLORIDEAmazon.com Services LLC52e5b1a4-3a84-c4cb-e063-6394a90a822c2026-07-07WarningsExact identifier
application number: M003
Amazon Basics Fresh Scent Antibacterial Hand WipesBENZALKONIUM CHLORIDEAmazon.com Services LLC5256f38a-74b6-0d18-e063-6294a90a5b462026-07-07WarningsExact identifier
application number: M003
Hand SanitizerETHYL ALCOHOLEverywhereAire LLCb48f9e6b-c616-3607-e053-2995a90a37f52026-07-06WarningsExact identifier
application number: M003
PlaneAire Hands hand sanitizerETHYL ALCOHOLEverywhereAire LLCb6af3009-78c2-2312-e053-2995a90af90a2026-07-06WarningsExact identifier
application number: M003
Hand Sanitizer gelALCOHOLEverywhereAire LLCd2a6c866-3f1e-20f1-e053-2995a90a26cc2026-07-06WarningsExact identifier
application number: M003
PlaneAire HandsHAND SANITIZER ETHANOL-BASEDEverywhereAire LLCeab3ab67-cb27-6c2b-e053-2a95a90ace122026-07-06WarningsExact identifier
application number: M003
PlaneAire Hands SandalwoodETHANOL HAND SANITIZEREverywhereAire LLC18612a10-8667-b0ef-e063-6394a90a208e2026-07-06WarningsExact identifier
application number: M003
PlaneAire HandsETHANOL HAND SANITIZEREverywhereAire LLCb86824c2-4fae-d597-e053-2995a90ad1da2026-07-06WarningsExact identifier
application number: M003
PlaneAire Hands Lemon Olive Oil Hand SanitizerETHANOL HAND SANITIZEREverywhereAire LLC42f8c2fb-a4e6-9416-e063-6294a90af9d52026-07-06WarningsExact identifier
application number: M003
PlaneAire HandsHAND SANITIZER ETHANOL BASEDEverywhereAire LLceab52ae1-f588-b08b-e053-2995a90a96b22026-07-06WarningsExact identifier
application number: M003
PlaneAire Hands hand sanitizerHAND SANITIZER ETHANOL-BASEDEverywhereAire LLCeab19649-21fc-2fa4-e053-2995a90a90f92026-07-06WarningsExact identifier
application number: M003

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55118-701-10551180701101000 mL in 1 CARTRIDGE (55118-701-10) 1000 ml2015-09-010000-00-00NoNoCurrent
55118-701-115511807011145 mL in 1 BOTTLE, PUMP45 mlHistorical
55118-701-12551180701121200 mL in 1 CARTRIDGE (55118-701-12) 1200 ml2015-09-010000-00-00NoNoCurrent
55118-701-1855118070118532 mL in 1 BOTTLE, PUMP532 mlHistorical
55118-701-645511807016424 BOTTLE, PUMP in 1 CARTON (55118-701-64) / 45 mL in 1 BOTTLE, PUMP (55118-701-11) 2015-09-010000-00-00NoNoCurrent
55118-701-67551180701674 BOTTLE, PUMP in 1 CARTON (55118-701-67) / 532 mL in 1 BOTTLE, PUMP (55118-701-18) 2015-09-010000-00-00NoNoCurrent
55118-701-9955118070199473 mL in 1 BOTTLE, PUMP (55118-701-99) 473 ml2015-09-010000-00-00NoNoCurrent