FDA.reportPublic FDA data

Hand Sanitizer with Aloe

Product NDC
59958-500
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

Additional Listing Data#

Finished product
Yes
Brand name base
Hand Sanitizer with Aloe

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ALCOHOL65 g/100g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii3K9958V90M
Rxcui902574

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

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
59958-500-01599580500013700 g in 1 BOTTLE, PUMP (59958-500-01) 3700 g2020-03-230000-00-00NoNoCurrent
59958-500-025995805000218500 g in 1 BOTTLE, PUMP (59958-500-02) 18500 g2020-03-230000-00-00NoNoCurrent
59958-500-035995805000318500 g in 1 BOTTLE, PUMP (59958-500-03) 18500 g2020-03-232026-12-31NoNoCurrent
59958-500-055995805000510100 g in 1 DRUM (59958-500-05) 10100 g2020-03-230000-00-00NoNoCurrent
59958-500-0659958050006360 g in 1 BOTTLE, PUMP (59958-500-06) 360 g2020-03-230000-00-00NoNoCurrent
59958-500-0759958050007925000 g in 1 TANK (59958-500-07) 925000 g2020-03-232026-12-24NoNoCurrent
59958-500-0859958050008185000 g in 1 DRUM (59958-500-08) 185000 g2020-03-230000-00-00NoNoCurrent