FDA.reportPublic FDA data

Hand Sanitizer with Aloe

Product NDC
59958-500
Requested package NDC
59958-500-02
11-digit product format
599580500
Labeler code
59958
Product ID
59958-500_512adaba-6c0c-7589-e063-6294a90a22c5
Type
HUMAN OTC DRUG
Nonproprietary name
65% Ethyl Alcohol
Dosage form
GEL
Route
TOPICAL
Labeler
Owen Biosciences, Inc.
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-03-23
Marketing end
2026-12-24
Substance
ALCOHOL
Active strength
65 g/100g
NDC exclude flag
No
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 packagepackage59958-50059958-500-02DDiscontinued 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
Hand Sanitizer with Aloe

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ALCOHOL65 g/100g

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
902574Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
fb93b4f6-9eaf-4c35-a110-1f526ca7c373Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
59958-500-032026-01-29C16284748780-149896155-ae55-586f-e063-e6dba90add90Hand Sanitizer wth Aloe, 5 Gallon 18,500g

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59958-500-03Hand Sanitizer with Aloe18500 g in 1 BOTTLE, PUMPGEL185006
59958-500-07Hand Sanitizer with Aloe925000 g in 1 TANKGEL9250005

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59958-500HAND SANITIZER WITH ALOE (65% ETHYL ALCOHOL) GEL [OWEN BIOSCIENCES, INC.]5Current NDC, Legacy NDC, 1 package rows20241106_57f60d9e-954d-413d-ab3b-e4b800d072bf.zip
59958-500HAND SANITIZER WITH ALOE (65% ETHYL ALCOHOL) GEL [OWEN BIOSCIENCES, INC.]4Current NDC, Legacy NDC20241107_209ca570-1a53-4f12-bfc6-8ca33a72eaba.zip
59958-500HAND SANITIZER WITH ALOE (65% ETHYL ALCOHOL) GEL [OWEN BIOSCIENCES, INC.]4Current NDC, Legacy NDC20241107_b507804f-61a1-4f05-8b06-23073e795812.zip
59958-500HAND SANITIZER WITH ALOE (65% ETHYL ALCOHOL) GEL [OWEN BIOSCIENCES, INC.]4Current NDC, Legacy NDC20241107_cdaf6db9-c7df-41bc-a74c-0111694dbe9d.zip
59958-500HAND SANITIZER WITH ALOE (65% ETHYL ALCOHOL) GEL [OWEN BIOSCIENCES, INC.]4Current NDC, Legacy NDC20250114_b2de572a-bb7b-419f-856c-23231c3da921.zip
59958-500HAND SANITIZER WITH ALOE (65% ETHYL ALCOHOL) GEL [OWEN BIOSCIENCES, INC.]4Current NDC, Legacy NDC, 1 package rows20241106_fb93b4f6-9eaf-4c35-a110-1f526ca7c373.zip
59958-500HAND SANITIZER WITH ALOE (65% ETHYL ALCOHOL) GEL [OWEN BIOSCIENCES, INC.]4Current NDC, Legacy NDC20241107_54c681f2-c42c-4f91-8af8-d77f156993f5.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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hand Sanitizer with Aloe65% ETHYL ALCOHOLOwen Biosciences, Inc.fb93b4f6-9eaf-4c35-a110-1f526ca7c3732026-05-06WarningsExact identifier
ndc (product): 59958-500
Hand Sanitizer with Aloe65% ETHYL ALCOHOLOwen Biosciences, Inc.57f60d9e-954d-413d-ab3b-e4b800d072bf2026-05-06WarningsExact identifier
ndc (product): 59958-500

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
902574ethanol 65 % Topical GelPSN57f60d9e-954d-413d-ab3b-e4b800d072bf6
902574ethanol 0.65 ML/ML Topical GelSCD57f60d9e-954d-413d-ab3b-e4b800d072bf6
902574ethyl alcohol 65 % Topical GelSY57f60d9e-954d-413d-ab3b-e4b800d072bf6
902574ethanol 65 % Topical GelPSNfb93b4f6-9eaf-4c35-a110-1f526ca7c3735
902574ethanol 0.65 ML/ML Topical GelSCDfb93b4f6-9eaf-4c35-a110-1f526ca7c3735
902574ethyl alcohol 65 % Topical GelSYfb93b4f6-9eaf-4c35-a110-1f526ca7c3735

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59958-500-025995805000218500 g in 1 BOTTLE, PUMP (59958-500-02) 18500 g2020-03-230000-00-00NoNoCurrent