FDA.reportPublic FDA data

Foaming Hand Sanitizer

Product NDC
75044-280
11-digit product format
750440280
Labeler code
75044
Product ID
75044-280_dcefd1ab-5791-4e0d-804f-df19590ef8cf
Type
HUMAN OTC DRUG
Nonproprietary name
Hand Sanitizer
Dosage form
LIQUID
Route
TOPICAL
Labeler
American Chemical Systems II, LLC
Application
M003
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-09-01
Substance
BENZALKONIUM CHLORIDE
Active strength
1.3 g/1000mL
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
Foaming Hand Sanitizer
Listing expiration
2026-12-31

Active Ingredients#

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

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1020365Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
3085d595-68b7-4100-81c0-f0699a7609d6Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
75044-280-16Foaming Hand Sanitizer2 in 1 CASELIQUID22
75044-280-16Foaming Hand Sanitizer3800 mL in 1 BOTTLE, PLASTICLIQUID38002
75044-280-31Foaming Hand Sanitizer1000 mL in 1 BOTTLE, PLASTICLIQUID10002
75044-280-31Foaming Hand Sanitizer3 in 1 CASELIQUID32

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
75044-280FOAMING HAND SANITIZER (HAND SANITIZER) LIQUID [AMERICAN CHEMICAL SYSTEMS II, LLC]1Current NDC, 4 package rows20241004_3085d595-68b7-4100-81c0-f0699a7609d6.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 109 of 114 · 2,277 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
RevitaDERM Wound CareBENZALKONIUM CHLORIDEBlaine Labs Inc.9254dada-4e32-43a0-892b-c488d68e23e72023-12-21WarningsExact identifier
application number: M003
NUMSTAT Antiseptic and Pain Relieving Prep PadALCOHOL, MENTHOL, AND BENZOCAINE PREP PADSpectra Medical Devices, LLC07d20040-9dd9-0aba-e063-6294a90ab7cf2023-12-20WarningsExact identifier
application number: M003
Health Mart IodidesALCOHOLStrategic Sourcing Services LLC8d9f2112-c678-4559-b567-9d6d287c5fa32023-12-20WarningsExact identifier
application number: M003
Health Mart Iodine Tincture MildIODINE AND SODIUM IODIDE AND ALCOHOLStrategic Sourcing Services LLC72eeb3e6-c0a1-4b18-87f1-8db06f9bd1112023-12-20WarningsExact identifier
application number: M003
Health Mart Hydrogen Peroxide 3 PercentHYDROGEN PEROXIDEStrategic Sourcing Services LLCcbe02fa1-c167-4b77-8f63-817362090e192023-12-20WarningsExact identifier
application number: M003
Health Mart Isopropyl Alcohol 91 PercentISOPROPYL ALCOHOLStrategic Sourcing Services LLCfbd2aa69-b1c7-4a28-9642-a436ae09faaf2023-12-20WarningsExact identifier
application number: M003
Quality Choice Povidone IodinePOVIDONE IODINE 10%Chain Drug Market Association9fa49a3c-ad09-4d35-8cd9-e1a0f2da0d2d2023-12-20WarningsExact identifier
application number: M003
Quality Choice Iodine Tincture MildIODINE AND SODIUM IODIDE AND ALCOHOLChain Drug Market Association55c970ed-13a9-4ea2-a8cb-aaf14d3a214d2023-12-20WarningsExact identifier
application number: M003
Quality Choice Iodides TinctureETHYL ALCOHOLChain Drug Market Association71aedfd5-e81f-4b69-b163-527ff1ce30b12023-12-20WarningsExact identifier
application number: M003
Quality Choice MerthiolateBENZALKONIUM CHLORIDEChain Drug Market Association5b7303b9-b8c4-4e7c-876f-70ed764430552023-12-20WarningsExact identifier
application number: M003
Premier Value Povidone IodinePOVIDONE IODINE 10%Chain Drug Consortium5cc9d782-5f7e-27d9-e053-2991aa0a24282023-12-20WarningsExact identifier
application number: M003
Harris Teeter Iodine Tincture MildIODINE AND SODIUM IODIDE AND ALCOHOLHarris Teeter, LLC5c88d7cb-2917-54e9-e053-2991aa0a0bd92023-12-20WarningsExact identifier
application number: M003
CVS IodineIODINE, SODIUM IODIDE AND ALCOHOLCVS Pharmacyb11db4e5-6a6d-4d4a-b980-600692b541762023-12-20WarningsExact identifier
application number: M003
CVS Povidone-IodinePOVIDONE IODINECVS Pharmacy402d571f-e1e8-43fd-9e7b-05aab18379052023-12-20WarningsExact identifier
application number: M003
Sanitizing wipes with aloe Grapefruit GroveALCOHOLThe Honest Companyfaa3690b-ce0d-43d4-9e5c-f2ce77daabe72023-12-19WarningsExact identifier
application number: M003
Sanitizing Wipes Fragrance FreeALCOHOLThe Honest Company0ce3e7ee-aa50-16bc-e063-6294a90a527d2023-12-19WarningsExact identifier
application number: M003
sunmark Isopropyl Rubbing AlcoholISOPROPYL ALCOHOLStrategic Sourcing Services LLC46da2750-37d1-4ed1-baf3-1fd4266175672023-12-19WarningsExact identifier
application number: M003
Sunmark IodineIODINE, SODIUM IODIDE, ALCOHOLStrategic Sourcing Services LLCe8dae2d6-58b1-4c4e-a4c1-371db055b7ae2023-12-19WarningsExact identifier
application number: M003
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1020365benzalkonium chloride 0.13 % Topical FoamPSN3085d595-68b7-4100-81c0-f0699a7609d62
1020365benzalkonium chloride 1.3 MG/ML Topical FoamSCD3085d595-68b7-4100-81c0-f0699a7609d62
1020365benzalkonium chloride 0.13 % Topical FoamSY3085d595-68b7-4100-81c0-f0699a7609d62

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
75044-280-16750440280162 BOTTLE, PLASTIC in 1 CASE (75044-280-16) / 3800 mL in 1 BOTTLE, PLASTIC2024-09-01NoNoCurrent
75044-280-31750440280313 BOTTLE, PLASTIC in 1 CASE (75044-280-31) / 1000 mL in 1 BOTTLE, PLASTIC2024-09-01NoNoCurrent