FDA.reportPublic FDA data

X3 Clean American Hand Sanitizer Alcohol Free

Product NDC
26550-005
11-digit product format
265500005
Labeler code
26550
Product ID
26550-005_5e454598-936a-8cef-e063-6394a90a23f6
Type
HUMAN OTC DRUG
Nonproprietary name
Benzalkonium Chloride
Dosage form
LIQUID
Route
TOPICAL
Labeler
X3 Labs Inc
Application
M003
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2026-10-20
Substance
BENZALKONIUM CHLORIDE
Active strength
1.3 mg/mL
NDC exclude flag
No
Listing certified through
2027-12-31
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
X3 Clean American Hand Sanitizer Alcohol Free
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BENZALKONIUM CHLORIDE1.3 mg/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 RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1049254Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
5e454598-9369-8cef-e063-6394a90a23f6Available on FDA.report

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 106 of 110 · 2,198 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sunmark Isopropyl Alcohol 70 Percent With Wintergreen OilISOPROPYL ALCOHOLStrategic Sourcing Services LLC515dd733-1b44-4df0-928f-a3b202b5f9c22023-12-19WarningsExact identifier
application number: M003
Sunmark Isopropyl Alcohol 91 PercentISOPROPYL ALCOHOLStrategic Sourcing Services LLC92afb1ce-6a9e-456e-b3ee-e8a8d93ebc5e2023-12-19WarningsExact identifier
application number: M003
Sunmark Hydrogen Peroxide 3 PercentHYDROGEN PEROXIDEStrategic Sourcing Services LLCc79ae066-8b3b-400d-8b26-f41100e7f5342023-12-19WarningsExact identifier
application number: M003
Sunmark Iodides TinctureETHYL ALCOHOLStrategic Sourcing Services LLC5e227f79-fca7-4633-97ea-61da4060fe922023-12-19WarningsExact identifier
application number: M003
sunmark Povidone-Iodine TopicalPOVIDONE-IODINEStrategic Sourcing Services LLCacc349d6-2875-4814-aa6e-828fffec7f072023-12-19WarningsExact identifier
application number: M003
DDM Iodine Tincture MildIODINE AND SODIUM IODIDE AND ALCOHOLDiscount Drug Mart5d538c8e-bf87-d85c-e053-2991aa0af7292023-12-19WarningsExact identifier
application number: M003
DDM Decolorized IodineETHYL ALCOHOLDiscount Drug Mart5d570ea7-ab08-54b7-e053-2991aa0a7a832023-12-19WarningsExact identifier
application number: M003
DDM Povidone IodinePOVIDONE IODINE 10%Discount Drug Mart5d161a9d-0462-0afd-e053-2991aa0a22e22023-12-19WarningsExact identifier
application number: M003
HEB Povidone IodinePOVIDONE IODINE 10%H E B5d576ce2-7d63-c860-e053-2a91aa0a072c2023-12-18WarningsExact identifier
application number: M003
Publix Povidone IodinePOVIDONE IODINE 10%Publix5d6bba46-2571-4957-e053-2a91aa0a2e852023-12-18WarningsExact identifier
application number: M003
Top Care Decolorized IodineETHYL ALCOHOLTOPCO ASSOCIATES LLC5d6bdc17-5c3a-7dec-e053-2991aa0aa4502023-12-18WarningsExact identifier
application number: M003
Tincture MerthiolateBENZALKONIUM CHLORIDEDLC Laboratories, Inc4fec9119-fbbf-4fc7-9122-c6300cac87312023-12-18WarningsExact identifier
application number: M003
70% ISOPROPYL RUBBING ALCOHOL WITH WINTERGREENISOPROPYL ALCOHOLNew Pride Corp0c9e1e9c-b8fc-1932-e063-6394a90a09bf2023-12-16WarningsExact identifier
application number: M003
DermaWound Wound CarePOVIDONE-IODINEProgressive Doctors, LLC2d49daa7-aa02-4219-880b-e1697bde8a7e2023-12-15WarningsExact identifier
application number: M003
Ethyl Rubbing AlcoholALCOHOLHumco Holding Group, Inc.829f3e16-7a9b-4da7-87d2-f58254bda7212023-12-15WarningsExact identifier
application number: M003
Humco Iodides TinctureETHYL ALCOHOLHumco Holding Group, Inc.d230e3a2-1cde-44a9-82c3-3dc5474b3a722023-12-15WarningsExact identifier
application number: M003
Humco Hydrogen PeroxideHYDROGEN PEROXIDE 3%Humco Holding Group, Inc.2fdd3aa0-e45e-46bb-aa01-88e59d8afbfd2023-12-15WarningsExact identifier
application number: M003
HUMCO Isopropyl Rubbing Alcohol 70%ISOPROPYL ALCOHOLHumco Holding Group, Inc.c220b916-6914-435f-84e2-ba828c9916b12023-12-15WarningsExact identifier
application number: M003
HUMCO Isopropyl Rubbing Alcohol 70% Professional PackISOPROPYL ALCOHOLHumco Holding Group, Inc.8de61fdd-8bb9-4845-9129-97bed0686a682023-12-15WarningsExact identifier
application number: M003
HUMCO MerthiolateBENZALKONIUM CHLORIDEHumco Holding Group, Inc.864063a5-c6cc-4657-9cd6-51af4673bf982023-12-15WarningsExact identifier
application number: M003

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
26550-005-7626550000576225 mL in 1 BOTTLE, PUMP (26550-005-76) 225 ml2026-10-20NoNoCurrent