FDA.reportPublic FDA data

Instant Hand Antiseptic

Product NDC
59448-003
11-digit product format
594480003
Labeler code
59448
Product ID
59448-003_c5011eba-9aad-4a0c-a4e1-40b10df0402c
Type
HUMAN OTC DRUG
Nonproprietary name
Benzalkonium Chloride
Dosage form
GEL
Route
TOPICAL
Labeler
ASP Global
Application
M003
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2018-11-27
Substance
BENZALKONIUM CHLORIDE
Active strength
.095 mg/100mL
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
Instant Hand Antiseptic
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BENZALKONIUM CHLORIDE.095 mg/100mL

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
2048259Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
47276148-08e5-400e-94ac-d2d9db423b51Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59448-003-01Univ of Vermont Medical Center Amenity53 mL in 1 BOTTLE, PLASTICGEL53 mL0.095 mg in 100mL5
59448-003-01Instant Hand Antiseptic53 mL in 1 BOTTLE, PLASTICGEL535

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59448-003INSTANT HAND ANTISEPTIC (BENZALKONIUM CHLORIDE) GEL [ASP GLOBAL]5Current NDC, Legacy NDC, 1 package rows20241208_47276148-08e5-400e-94ac-d2d9db423b51.zip
59448-003UNIV OF VERMONT MEDICAL CENTER AMENITY (BENZALKONIUM CHLORIDE AND SODIUM MONOFLUOROPHOSPHATE) KIT [ASP GLOBAL, LLC]5Current NDC, Legacy NDC20241222_7841cfa9-e94e-4c3d-b5fb-676924017845.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 111 of 115 · 2,286 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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
Povidone IodinePOVIDONE-IODINE SPRAY 5%Humco Holding Group, Inc.a7bb80c4-bbc0-21ea-e053-2995a90a52c12023-12-15WarningsExact identifier
application number: M003
Povidone IodinePOVIDONE IODINE 10%Humco Holding Group, Inc.6064c23b-7c15-208d-e053-2991aa0a00f62023-12-15WarningsExact identifier
application number: M003
Povidone IodinePOVIDONE IODINE GARGLE 0.5%Humco Holding Group, Inc.a7b9ad55-cfeb-6066-e053-2a95a90af9752023-12-15WarningsExact identifier
application number: M003
Rite Aid Povidone IodinePOVIDONE IODINE 10%Rite Aid Corporation5df6ff37-a4ea-d666-e053-2991aa0a97862023-12-15WarningsExact identifier
application number: M003
Rite Aid Decolorized IodineETHYL ALCOHOLRite Aid Corporation5e0d3664-b02a-ba28-e053-2991aa0a8a4c2023-12-15WarningsExact identifier
application number: M003
De La Cruz Tincture of IodineIODINE AND SODIUM IODIDE AND ALCOHOLDLC Laboratories, Inc.5d8f60a9-6d1c-0b0f-e053-2991aa0a8a9b2023-12-15WarningsExact identifier
application number: M003
ALCOHOL ANTISEPTIC HAND SANITIZER ANTIBACTERIALALCOHOLZhejiang Guoyao Jingyue Aerosol Co., Ltd.0c73f4f5-2b1d-84ae-e063-6394a90a5d7b2023-12-14WarningsExact identifier
application number: M003
TaeTu AftercareBENZALKONIUM CHLORIDETaetu LLCdec15a4d-1a33-a78a-e053-2995a90a69fe2023-12-14WarningsExact identifier
application number: M003
GNP Idoinde Tincture 2% MildIODINE AND SODIUM IODIDE AND ALCOHOLAmerisource Bergen32ad75b8-abd1-4151-a035-b6c9ae5fc8882023-12-14WarningsExact identifier
application number: M003
Antibacterial Wet WipesBENZALKONIUM CHLORIDEHangZhou YangYi Daily Cosmetics Technology Co., Ltd.85d3914d-dbb8-5036-e053-2a91aa0a7cd42023-12-13WarningsExact identifier
application number: M003
AntiochPharma Rapidgel Hand SanitizerALCOHOLWeeks & Leo0c57a9ea-de66-3ced-e063-6294a90a4b8d2023-12-12WarningsExact identifier
application number: M003
antiseptic hand sanitizer 01ALCOHOLCosmuses Cosmetics (Ningbo) Co., Ltd.e9f9b7b6-fed7-10e1-e053-2a95a90a9aa62023-12-11WarningsExact identifier
application number: M003
AntiochPharma Hand SanitizerALCOHOLWeeks & Leoa1a0d368-b004-59b8-e053-2995a90ab4b12023-12-11WarningsExact identifier
application number: M003

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2048259benzalkonium chloride 0.095 % Topical GelPSN47276148-08e5-400e-94ac-d2d9db423b515
2048259benzalkonium chloride 0.095 % Topical GelPSN7841cfa9-e94e-4c3d-b5fb-6769240178455
545626sodium monofluorophosphate 0.76 % ToothpastePSN7841cfa9-e94e-4c3d-b5fb-6769240178455
2048259benzalkonium chloride 0.00095 MG/MG Topical GelSCD47276148-08e5-400e-94ac-d2d9db423b515
2048259benzalkonium chloride 0.00095 MG/MG Topical GelSCD7841cfa9-e94e-4c3d-b5fb-6769240178455
545626sodium monofluorophosphate 0.0076 MG/MG ToothpasteSCD7841cfa9-e94e-4c3d-b5fb-6769240178455
2048259benzalkonium chloride 0.095 % Topical GelSY47276148-08e5-400e-94ac-d2d9db423b515
2048259benzalkonium chloride 0.095 % Topical GelSY7841cfa9-e94e-4c3d-b5fb-6769240178455
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.12 % )ToothpasteSY7841cfa9-e94e-4c3d-b5fb-6769240178455
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.13 % )ToothpasteSY7841cfa9-e94e-4c3d-b5fb-6769240178455
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.14 % )ToothpasteSY7841cfa9-e94e-4c3d-b5fb-6769240178455
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.15 % )ToothpasteSY7841cfa9-e94e-4c3d-b5fb-6769240178455

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59448-003-015944800030153 mL in 1 BOTTLE, PLASTIC (59448-003-01) 53 ml2018-11-270000-00-00NoNoCurrent