FDA.reportPublic FDA data

Antiseptic

Product NDC
68599-5322
Requested package NDC
68599-5322-2
11-digit product format
685995322
Labeler code
68599
Product ID
68599-5322_2437e8c6-05cf-e216-e063-6394a90ab626
Type
HUMAN OTC DRUG
Nonproprietary name
Ethanol
Dosage form
GEL
Route
TOPICAL
Labeler
McKesson
Application
M003
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2018-02-27
Substance
ALCOHOL
Active strength
.62 mL/mL
NDC exclude flag
No
Listing certified through
2027-12-31
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
Antiseptic
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ALCOHOL.62 mL/mL

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
6637290d-6ae4-5a83-e053-2991aa0a81c6Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68599-5322-1Antiseptic118 mL in 1 BOTTLEGEL1184
68599-5322-2Antiseptic24 in 1 CASEGEL244
68599-5322-4Antiseptic237 mL in 1 BOTTLEGEL2374
68599-5322-5Antiseptic24 in 1 CASEGEL244
68599-5322-6Antiseptic500 mL in 1 BOTTLEGEL5004

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68599-5322ANTISEPTIC (ETHANOL) GEL [MCKESSON]4Current NDC, Legacy NDC, 5 package rows20241013_6637290d-6ae4-5a83-e053-2991aa0a81c6.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 43 of 114 · 2,277 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Germ-AwayANTI-MICROBIALUnico International Trading Corpa7d40204-3f69-7fb7-e053-2995a90a278b2026-01-08WarningsExact identifier
application number: M003
Germ-AwayANTIBACTERIAL HAND WIPEUnico International Trading Corpad7d8546-d440-e661-e053-2a95a90a8fd32026-01-08WarningsExact identifier
application number: M003
Germ-AwayANTI-MICROBIALUnico International Trading Corpa7d47c07-12bd-3c8f-e053-2a95a90a95642026-01-08WarningsExact identifier
application number: M003
Germ-AwayANTI-MICROBIALUnico International Trading Corpa7d7f260-f5be-7940-e053-2995a90aaa032026-01-08WarningsExact identifier
application number: M003
Germ-AwayANTIBACTERIALUnico International Trading Corpada02f20-07ef-9e90-e053-2995a90a0e8b2026-01-08WarningsExact identifier
application number: M003
Germ-AwayANTI-BACTERIALUnico International Trading Corpadb59182-6541-2b35-e053-2a95a90a0f712026-01-08WarningsExact identifier
application number: M003
Castellani Paint 1.5%PHENOLThe Podiatree Companya10f18e0-b47c-424b-847e-bcc25aa250a42026-01-08WarningsExact identifier
application number: M003
Castellani Paint 1.5%PHENOLThe Podiatree Company5b8cff3c-71d2-418f-a43d-f570aa5408fd2026-01-08WarningsExact identifier
application number: M003
Fortinia IDPHENOLThe Podiatree Company60c88eb7-22fe-4881-e053-2a91aa0a70ce2026-01-08WarningsExact identifier
application number: M003
Gentian Violet 2%GENTIAN VIOLET 2%The Podiatree Company60ba9bb0-cc7a-1ccf-e053-2a91aa0ac4b82026-01-08WarningsExact identifier
application number: M003
Isopropyl Rubbing AlcoholISOPROPYL ALCOHOLNDC, Inc.07bfadf4-7452-4c7a-b60e-feb658b92e732026-01-08WarningsExact identifier
application number: M003
Hydrogen Peroxide 3%HYDROGEN PEROXIDE 3%Epic Medical Supply Corp.0da45476-46c3-428c-a2d9-70865d2b12772026-01-08WarningsExact identifier
application number: M003
Roll On Anti Perspirant Alcohol FreeALUMINUM CHLOROHYDRATEMedline Industries, LP4f706801-dc2d-48c4-aa06-92207d86e55e2026-01-08WarningsExact identifier
application number: M003
ProCure Antiseptic Wound CleanserBENZETHONIUM CHLORIDE 0.13%Twin Med LLC47e63ead-fdcc-15e9-e063-6394a90af8fa2026-01-08WarningsExact identifier
application number: M003
Isopropyl Rubbing AlcoholISOPROPYL ALCOHOLMcKesson Medical-Surgical Inc.57ac1673-0652-433b-8b79-962d14e5b3172026-01-08WarningsExact identifier
application number: M003
Isopropyl Rubbing AlcoholISOPROPYL ALCOHOLHenry Schein Inc.eeaf255e-497b-4672-bebc-4d3fcba904c72026-01-08WarningsExact identifier
application number: M003
Hydrogen PeroxideHYDROGEN PEROXIDEMcKesson Medical-Surgical Inc.fefaf5ff-e5f4-40d9-a415-a54fb5592ae12026-01-08WarningsExact identifier
application number: M003
Hydrogen PeroxideHYDROGEN PEROXIDENavajo Manufacturing Company Inc.0125929d-fabe-4e35-a3a9-a81c42211bed2026-01-08WarningsExact identifier
application number: M003
Hydrogen PeroxideHYDROGEN PEROXIDEMcKesson Medical-Surgical Inc.85d2d57d-6d0b-406a-8880-a697a8c3c6822026-01-08WarningsExact identifier
application number: M003
Hydrogen PeroxideHYDROGEN PEROXIDEHenry Schein Inc.d97671f0-b182-4dab-87d2-cf9919509da52026-01-08WarningsExact identifier
application number: M003

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
581660ethanol 62 % Topical GelPSN6637290d-6ae4-5a83-e053-2991aa0a81c64
581660ethanol 0.62 ML/ML Topical GelSCD6637290d-6ae4-5a83-e053-2991aa0a81c64
581660ethanol 62 % Topical GelSY6637290d-6ae4-5a83-e053-2991aa0a81c64

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68599-5322-26859953220224 BOTTLE in 1 CASE (68599-5322-2) / 118 mL in 1 BOTTLE (68599-5322-1) 24 bottle2018-02-270000-00-00NoNoCurrent