Antimicrobial

Product NDC
61010-3111
Requested package NDC
61010-3111-4
11-digit product format
610103111
Labeler code
61010
Product ID
61010-3111_10a9bfb1-8910-734f-e063-6294a90a20d7
Type
HUMAN OTC DRUG
Nonproprietary name
alcohol
Dosage form
LIQUID
Route
TOPICAL
Labeler
Safetec of America, Inc.
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2012-05-21
Substance
ALCOHOL
Active strength
665 mL/L
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
Antimicrobial
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ALCOHOL665 mL/L

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
1087912Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
4a070d45-f7fd-4eab-a2ba-48445d54fe5dAvailable on FDA.report

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61010-3111-1Antimicrobial0.0019 L in 1 PACKETLIQUID0.00196
61010-3111-1Antimicrobial100 in 1 BOXLIQUID1006
61010-3111-2Antimicrobial0.224 L in 1 CANISTERLIQUID0.2246
61010-3111-3Antimicrobial0.58 L in 1 CANISTERLIQUID0.586
61010-3111-4Antimicrobial1041 L in 1 CONTAINERLIQUID10416

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61010-3111ANTIMICROBIAL (ALCOHOL) LIQUID [SAFETEC OF AMERICA, INC.]6Current NDC, Legacy NDC, 5 package rows20240206_4a070d45-f7fd-4eab-a2ba-48445d54fe5d.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 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AntimicrobialALCOHOLSafetec of America, Inc.4a070d45-f7fd-4eab-a2ba-48445d54fe5d2024-02-05WarningsExact identifier
ndc (package): 61010-3111-4
ndc (product): 61010-3111
ndc11 (package): 61010311104

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1087912ethanol 66.5 % Topical SolutionPSN4a070d45-f7fd-4eab-a2ba-48445d54fe5d6
1087912ethanol 0.665 ML/ML Topical SolutionSCD4a070d45-f7fd-4eab-a2ba-48445d54fe5d6
1087912ethanol 66.5 % Topical SolutionSY4a070d45-f7fd-4eab-a2ba-48445d54fe5d6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61010-3111-4610103111041041 L in 1 CONTAINER (61010-3111-4) 1041 l2012-05-210000-00-00NoNoCurrent