FDA.reportPublic FDA data

Antibacterial Hand Sanitizer

Product NDC
71513-105
Requested package NDC
71513-105-06
11-digit product format
715130105
Labeler code
71513
Product ID
71513-105_43d13e36-df5e-eee2-e063-6394a90a60cf
Type
HUMAN OTC DRUG
Nonproprietary name
ETHYL ALCOHOL
Dosage form
GEL
Route
TOPICAL
Labeler
Broder Bros Co.
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-01-01
Substance
ALCOHOL
Active strength
62 mL/100mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage71513-10571513-105-06DDiscontinued by firm2026-10-05

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
Antibacterial Hand Sanitizer
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
b8183dae-4cdc-c369-e053-2995a90a75c4Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71513-105-01Antibacterial Hand Sanitizer29.57 mL in 1 BOTTLEGEL29.575
71513-105-03Antibacterial Hand Sanitizer59.12 mL in 1 BOTTLEGEL59.125
71513-105-04Antibacterial Hand Sanitizer236.59 mL in 1 BOTTLEGEL236.595
71513-105-05Antibacterial Hand Sanitizer473.18 mL in 1 BOTTLEGEL473.185
71513-105-06Antibacterial Hand Sanitizer14.79 mL in 1 BOTTLEGEL14.795
71513-105-50Antibacterial Hand Sanitizer29.57 mL in 1 TUBEGEL29.575

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71513-105ANTIBACTERIAL HAND SANITIZER (ETHYL ALCOHOL) GEL [BRODER BROS CO.]4Current NDC, Legacy NDC, 6 package rows20241023_b8183dae-4cdc-c369-e053-2995a90a75c4.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
Antibacterial Hand SanitizerETHYL ALCOHOLBroder Bros Co.b8183dae-4cdc-c369-e053-2995a90a75c42025-11-17WarningsExact identifier
ndc (package): 71513-105-06
ndc (product): 71513-105
ndc11 (package): 71513010506

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
581660ethanol 62 % Topical GelPSNb8183dae-4cdc-c369-e053-2995a90a75c45
581660ethanol 0.62 ML/ML Topical GelSCDb8183dae-4cdc-c369-e053-2995a90a75c45
581660ethanol 62 % Topical GelSYb8183dae-4cdc-c369-e053-2995a90a75c45

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71513-105-067151301050614.79 mL in 1 BOTTLE (71513-105-06) 14.79 ml2021-01-010000-00-00NoNoCurrent