FDA.reportPublic FDA data

Instant Hand Antiseptic

Product NDC
59448-004
11-digit product format
594480004
Labeler code
59448
Product ID
59448-004_b6a8ec30-bff9-4cd3-bb2b-584726d227c6
Type
HUMAN OTC DRUG
Nonproprietary name
Alcohol
Dosage form
GEL
Route
TOPICAL
Labeler
ASP Global
Application
M003
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2019-10-15
Substance
ALCOHOL
Active strength
62 mL/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
ALCOHOL62 mL/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
3K9958V90MInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
581660Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
b84075db-be0c-4265-b262-825bc6ade9d8Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
597b1cfd-7b31-5048-62be-ca5cd740da2fProduct name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59448-004-01Instant Hand Antiseptic53 mL in 1 BOTTLE, PLASTICGEL535
59448-004-01Emory Johns Creek Amenity53 mL in 1 BOTTLE, PLASTICGEL53 mL62 mL in 100mL4
59448-004-01Sarasota Memorial Amenity53 mL in 1 BOTTLE, PLASTICGEL53 mL62 mL in 100mL4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59448-004INSTANT HAND ANTISEPTIC (ALCOHOL) GEL [ASP GLOBAL]5Current NDC, Legacy NDC, 1 package rows20241208_b84075db-be0c-4265-b262-825bc6ade9d8.zip
59448-004EMORY JOHNS CREEK AMENITY (ALCOHOL AND SODIUM MONOFLUOROPHOSPATE) KIT [ASP GLOBAL]4Current NDC, Legacy NDC20241222_952ccb85-71bb-4d5d-ac9b-62851a39d36d.zip
59448-004SARASOTA MEMORIAL AMENITY (ALCOHOL AND SODIUM MONOFLUOROPHOSPHATE) KIT [ASP GLOBAL, LLC]4Current NDC, Legacy NDC20241222_f5dda019-fcfd-4e99-89cc-e79e76b402e7.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 29 of 115 · 2,286 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Walgreens Sanitizing WipesWALGREENS SANITIZING WIPESWalgreens42de3b25-692b-eaff-e063-6294a90a0d212026-03-11WarningsExact identifier
application number: M003
70% Isopropyl AlcoholISOPROPYL ALCOHOLAmazon.com Services LLC106f51fa-e687-470f-8ed8-35cb0565aeff2026-03-11Warnings, Adverse reactionsExact identifier
application number: M003
Isopropyl AlcoholISOPROPYL ALCOHOLAmazon.com Services LLC4ab76d25-136d-45e2-b9d7-964777e1d8552026-03-11Warnings, Adverse reactionsExact identifier
application number: M003
Hydrogen PeroxideHYDROGEN PEROXIDEPerrigo Direct, Inc2efcda54-b8b7-4266-89c0-7f686c7afdca2026-03-11Warnings, Adverse reactionsExact identifier
application number: M003
Alcohol Antiseptic PadsISOPROPYL ALCOHOLAcme United Corporation4cc307b9-aee2-3ce0-e063-6294a90aa1692026-03-11WarningsExact identifier
application number: M003
Isopropyl alcoholISOPROPYL ALCOHOLSalado Sales Inc.30294cad-d806-4d5b-8c86-484f22d214b62026-03-10Warnings, Adverse reactionsExact identifier
application number: M003
mild iodine tinctureIODINE AND SODIUM IODINE AND ALCOHOLKROGER COMPANY42762471-e5cb-505e-e063-6294a90afb7d2026-03-10WarningsExact identifier
application number: M003
Numstat Antiseptic and Pain-Relieving Prep PadANTISEPTIC AND PAIN-RELIEVING PREP PADSafetec of America Inc.4c9c20f2-bc17-857b-e063-6394a90a5d5c2026-03-09WarningsExact identifier
application number: M003
Eco Bandage OCEANBENZETHONIUM CHLORIDEECO Bandage LLCc7867df0-e167-4ec6-921b-6a0fb3cb06142026-03-06WarningsExact identifier
application number: M003
Eco Bandage HONEYBENZETHONIUM CHLORIDEEco Bandage LLCd2faa027-b274-43c0-9b87-85efab89fe8e2026-03-06WarningsExact identifier
application number: M003
Eco Bandage HIBISCUSBENZETHONIUM CHLORIDEEco Bandage LLC41f8716d-a970-40cd-a29d-69dafc97def82026-03-06WarningsExact identifier
application number: M003
Eco Bandage MOCHABENZETHONIUM CHLORIDEEco Bandage LLC11ec42e4-49d1-4690-80c3-784f2e30acd32026-03-06WarningsExact identifier
application number: M003
Eco Bandage SANDBENZETHONIUM CHLORIDEEco Bandage LLC5c620696-e8eb-445e-b746-5348ea37a2142026-03-06WarningsExact identifier
application number: M003
Eco Bandage sand oceanBENZETHONIUM CHLORIDEEco Bandage LLCda0c2d07-bc2a-4e7c-af45-f921375b52e12026-03-06WarningsExact identifier
application number: M003
MediChoice Antiseptic Isopropyl Alcohol Prep PadsISOPROPYL ALCOHOLO&M HALYARD, INC.20b3694e-04c7-4bca-b2ce-62ae0dec7a832026-03-05WarningsExact identifier
application number: M003
MediChoice Alcohol SwabstickISOPROPYL ALCOHOLO&M HALYARD, INC.7f78529d-df17-44b3-a890-1afa35308c672026-03-05WarningsExact identifier
application number: M003
MediChoice Alcohol Prep PadsISOPROPYL ALCOHOLO&M HALYARD, INC.f4f54448-0de0-448c-9b7b-104370953ae52026-03-05WarningsExact identifier
application number: M003
MediChoice Alcohol SwabstickISOPROPYL ALCOHOLO&M HALYARD, INC.7cee1141-4a49-4fec-a627-91a88e3d3ffc2026-03-05WarningsExact identifier
application number: M003
Loris BZK Antiseptic WipesBENZALKONIUM CHLORIDELernaPharm Loris Inc.a448de7b-4d96-4d53-ae1a-0bd38a2fb4a22026-03-05WarningsExact identifier
application number: M003
SPA HAND SANITIZER WRTER MELON SPLASHETHYL ALCOHOLRejoice International Corp.4c53620d-01ee-8ddd-e063-6294a90a8a2b2026-03-05WarningsExact identifier
application number: M003

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
581660ethanol 62 % Topical GelPSNb84075db-be0c-4265-b262-825bc6ade9d85
581660ethanol 0.62 ML/ML Topical GelSCDb84075db-be0c-4265-b262-825bc6ade9d85
581660ethanol 62 % Topical GelSYb84075db-be0c-4265-b262-825bc6ade9d85
581660ethanol 62 % Topical GelPSNf5dda019-fcfd-4e99-89cc-e79e76b402e74
581660ethanol 62 % Topical GelPSN952ccb85-71bb-4d5d-ac9b-62851a39d36d4
545626sodium monofluorophosphate 0.76 % ToothpastePSNf5dda019-fcfd-4e99-89cc-e79e76b402e74
545626sodium monofluorophosphate 0.76 % ToothpastePSN952ccb85-71bb-4d5d-ac9b-62851a39d36d4
581660ethanol 0.62 ML/ML Topical GelSCD952ccb85-71bb-4d5d-ac9b-62851a39d36d4
581660ethanol 0.62 ML/ML Topical GelSCDf5dda019-fcfd-4e99-89cc-e79e76b402e74
545626sodium monofluorophosphate 0.0076 MG/MG ToothpasteSCD952ccb85-71bb-4d5d-ac9b-62851a39d36d4
545626sodium monofluorophosphate 0.0076 MG/MG ToothpasteSCDf5dda019-fcfd-4e99-89cc-e79e76b402e74
581660ethanol 62 % Topical GelSY952ccb85-71bb-4d5d-ac9b-62851a39d36d4
581660ethanol 62 % Topical GelSYf5dda019-fcfd-4e99-89cc-e79e76b402e74
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.12 % )ToothpasteSY952ccb85-71bb-4d5d-ac9b-62851a39d36d4
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.12 % )ToothpasteSYf5dda019-fcfd-4e99-89cc-e79e76b402e74
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.13 % )ToothpasteSY952ccb85-71bb-4d5d-ac9b-62851a39d36d4
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.13 % )ToothpasteSYf5dda019-fcfd-4e99-89cc-e79e76b402e74
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.14 % )ToothpasteSYf5dda019-fcfd-4e99-89cc-e79e76b402e74
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.14 % )ToothpasteSY952ccb85-71bb-4d5d-ac9b-62851a39d36d4
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.15 % )ToothpasteSYf5dda019-fcfd-4e99-89cc-e79e76b402e74
545626sodium monofluorophosphate 0.76 % (fluoride ion 0.15 % )ToothpasteSY952ccb85-71bb-4d5d-ac9b-62851a39d36d4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59448-004-015944800040153 mL in 1 BOTTLE, PLASTIC (59448-004-01) 53 ml2019-10-150000-00-00NoNoCurrent