FDA.reportPublic FDA data

Instant Hand Antiseptic

Product NDC
59448-002
Requested package NDC
59448-002-01
11-digit product format
594480002
Labeler code
59448
Product ID
59448-002_0fcbb981-7868-4c18-bbfa-10870eb1eadf
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
2018-06-01
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
4eef4b0f-9209-45a4-8a0e-7891fc380fe5Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
597b1cfd-7b31-5048-62be-ca5cd740da2fProduct name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59448-002-01Englewood Amenity53 mL in 1 BOTTLE, PLASTICGEL53 mL0.095 mg in 100mL8
59448-002-01Instant Hand Antiseptic53 mL in 1 BOTTLE, PLASTICGEL535
59448-002-01Englewood Mesh Amenity53 mL in 1 BOTTLE, PLASTICGEL53 mL0.095 mg in 100mL4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59448-002ENGLEWOOD AMENITY (BENZALKONIUM CHLORIDE AND SODIUM MONOFLUOROPHOSPHATE) KIT [ASP GLOBAL, LLC]8Current NDC, Legacy NDC20241222_7c9ce1bf-6aa2-4073-ad09-2ddf845102a2.zip
59448-002INSTANT HAND ANTISEPTIC (BENZALKONIUM CHLORIDE) GEL [ASP GLOBAL]5Current NDC, Legacy NDC, 1 package rows20241207_4eef4b0f-9209-45a4-8a0e-7891fc380fe5.zip
59448-002ENGLEWOOD MESH AMENITY (BENZALKONIUM CHLORIDE AND SODIUM MONOFLUOROPHOSPHATE) KIT [ASP GLOBAL, LLC]3Current NDC, Legacy NDC20191010_a737fe63-6285-41ee-9516-9c3030a0ab48.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 83 of 114 · 2,277 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
XTRABENZALKONIUM CHLORIDEMY IMPORTS USA LLC27f4ff15-5480-8842-e063-6294a90ad35b2025-03-06WarningsExact identifier
application number: M003
Isopropyl Rubbing AlcoholISOPROPYL ALCOHOLUniversal Distribution Center LLC2f982aef-4f46-aa85-e063-6394a90a52b12025-03-05WarningsExact identifier
application number: M003
ISOPROPYL RUBBING ALCOHOL 50% WITH WINTERGREENISOPROPYL ALCOHOLUniversal Distribution Center LLC2f9846ce-37ca-a95b-e063-6294a90ad2602025-03-05WarningsExact identifier
application number: M003
Isopropyl Rubbing Alcohol 70%ISOPROPYL ALCOHOLUniversal Distribution Center LLC2f988951-39e7-ec02-e063-6294a90aaad72025-03-05WarningsExact identifier
application number: M003
Isopropyl alcoholISOPROPYL ALCOHOLUniversal Distribution Center LLC2f98a900-6c7c-0161-e063-6294a90ac6752025-03-05WarningsExact identifier
application number: M003
3 Hydrogen PeroxideHYDROGEN PEROXIDEUniversal Distribution Center LLC2f98ba8c-0ab1-e256-e063-6394a90abe8f2025-03-05WarningsExact identifier
application number: M003
Smart Care Assorted Hand Sanitizer Cherry Blossom 01ALCOHOLShenzhen Lantern Scicence Co.,Ltd.2f800ea4-b8bb-0cb4-e063-6294a90a7e232025-03-04WarningsExact identifier
application number: M003
Thera Plus Pain Relief CleansingBENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDEFourstar Group USA, Inc.513a620e-f69a-488d-8abc-36e2efccdc132025-03-04WarningsExact identifier
application number: M003
Clorox Hand SanitizerALCOHOLBrand Buzz LLCbdd47d2f-5332-1430-e053-2a95a90a1c332025-03-03WarningsExact identifier
application number: M003
T/T WAG Hand Sanitizer Mist Watermelon 01ALCOHOLShenzhen Lantern Scicence Co.,Ltd.2f7c4066-3baa-25f2-e063-6394a90a00eb2025-03-03WarningsExact identifier
application number: M003
Procure Products Hand Sanitizing WipesALCOHOL 70% ANTIBACTERIAL WIPESTWIN MED LLC1f378bee-88f7-14cf-e063-6394a90a48882025-02-28WarningsExact identifier
application number: M003
Instant Hand SanitizerINSTANT HAND SANITIZERRaining Rose, Inc2f37a2a1-5250-4052-e063-6294a90aef7f2025-02-28WarningsExact identifier
application number: M003
Signature Care Advanced Hand Sanitizer with AloeALCOHOLYiwu Yangjie Daily Chemicals Co.,Ltd.a20c821a-80d9-499c-aecd-3cf4d8e025902025-02-27WarningsExact identifier
application number: M003
Signature Care Advanced Hand SanitizerALCOHOLYiwu Yangjie Daily Chemicals Co.,Ltd.d5d0badb-5e1b-4ea8-bea2-0e8cf714b69e2025-02-27WarningsExact identifier
application number: M003
Signature Care Advanced Hand Sanitizer with AloeALCOHOLYiwu Yangjie Daily Chemicals Co.,Ltd.f2309f34-a1ee-44c7-b818-7384de64d27b2025-02-27WarningsExact identifier
application number: M003
Signature Care Advanced Hand SanitizerALCOHOLYiwu Yangjie Daily Chemicals Co.,Ltd.dcfc08a0-ecd6-42d3-9ff2-e68d5317152f2025-02-27WarningsExact identifier
application number: M003
Isopropyl alcoholISOPROPYL ALCOHOLAmerisourceBergen (Good Neighbor Pharmacy) 46122c47986e9-c851-491b-817e-fd3e0b054cd42025-02-26WarningsExact identifier
application number: M003
Isopropyl alcoholISOPROPYL ALCOHOLAmerisourceBergen (Good Neighbor Pharmacy) 4612200737139-bab8-40be-ad85-32526b5eab102025-02-26WarningsExact identifier
application number: M003
AUM Alcohol PadALCOHOL PADSLV PHARMACEUTICALS LLC DBA AUM PHARMACEUTICALS632da1b7-70bb-467d-81b2-39536f9fff3c2025-02-26WarningsExact identifier
application number: M003
Hand SanitizerALCOHOLUniversal Synergetics, Inc0dd6884c-935f-4523-b19a-201b7a8666fc2025-02-24WarningsExact identifier
application number: M003

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2048259benzalkonium chloride 0.095 % Topical GelPSN7c9ce1bf-6aa2-4073-ad09-2ddf845102a28
545626sodium monofluorophosphate 0.76 % ToothpastePSN7c9ce1bf-6aa2-4073-ad09-2ddf845102a28
2048259benzalkonium chloride 0.00095 MG/MG Topical GelSCD7c9ce1bf-6aa2-4073-ad09-2ddf845102a28
545626sodium monofluorophosphate 0.0076 MG/MG ToothpasteSCD7c9ce1bf-6aa2-4073-ad09-2ddf845102a28
2048259benzalkonium chloride 0.095 % Topical GelSY7c9ce1bf-6aa2-4073-ad09-2ddf845102a28
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.12 % )ToothpasteSY7c9ce1bf-6aa2-4073-ad09-2ddf845102a28
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.13 % )ToothpasteSY7c9ce1bf-6aa2-4073-ad09-2ddf845102a28
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.14 % )ToothpasteSY7c9ce1bf-6aa2-4073-ad09-2ddf845102a28
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.15 % )ToothpasteSY7c9ce1bf-6aa2-4073-ad09-2ddf845102a28
2048259benzalkonium chloride 0.095 % Topical GelPSN4eef4b0f-9209-45a4-8a0e-7891fc380fe55
2048259benzalkonium chloride 0.00095 MG/MG Topical GelSCD4eef4b0f-9209-45a4-8a0e-7891fc380fe55
2048259benzalkonium chloride 0.095 % Topical GelSY4eef4b0f-9209-45a4-8a0e-7891fc380fe55
2048259benzalkonium chloride 0.095 % Topical GelPSNa737fe63-6285-41ee-9516-9c3030a0ab484
545626sodium monofluorophosphate 0.76 % ToothpastePSNa737fe63-6285-41ee-9516-9c3030a0ab484
2048259benzalkonium chloride 0.00095 MG/MG Topical GelSCDa737fe63-6285-41ee-9516-9c3030a0ab484
545626sodium monofluorophosphate 0.0076 MG/MG ToothpasteSCDa737fe63-6285-41ee-9516-9c3030a0ab484
2048259benzalkonium chloride 0.095 % Topical GelSYa737fe63-6285-41ee-9516-9c3030a0ab484
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.12 % )ToothpasteSYa737fe63-6285-41ee-9516-9c3030a0ab484
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.13 % )ToothpasteSYa737fe63-6285-41ee-9516-9c3030a0ab484
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.14 % )ToothpasteSYa737fe63-6285-41ee-9516-9c3030a0ab484
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.15 % )ToothpasteSYa737fe63-6285-41ee-9516-9c3030a0ab484

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59448-002-015944800020153 mL in 1 BOTTLE, PLASTIC (59448-002-01) 53 ml2018-06-010000-00-00NoNoCurrent