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 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

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