Oustane Hand Sanitizer

Product NDC
79128-000
11-digit product format
791280000
Labeler code
79128
Product ID
79128-000_a9392820-8a34-09c5-e053-2995a90a9954
Type
HUMAN OTC DRUG
Nonproprietary name
ALCOHOL
Dosage form
GEL
Route
TOPICAL
Labeler
Cadence Keen Innovations, Inc.
Application
part333E
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2020-06-22
Marketing end
0000-00-00
Substance
ALCOHOL
Active strength
1 mL/mL
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
79128-000-012022-01-28C16284748780-1d6a99b39-f68e-a426-e053-dadaa90af4c2O'ustane Hand Sanitizer
79128-000-162022-01-28C16284748780-1d6a99b39-f68e-a426-e053-dadaa90af4c2O'ustane Hand Sanitizer
79128-000-372022-01-28C16284748780-1d6a99b39-f68e-a426-e053-dadaa90af4c2O'ustane Hand Sanitizer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
79128-000-01Oustane Hand Sanitizer50 mL in 1 BOTTLEGEL501
79128-000-16Oustane Hand Sanitizer500 mL in 1 BOTTLEGEL5001
79128-000-37Oustane Hand Sanitizer3785 mL in 1 DRUMGEL37851

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
79128-000OUSTANE HAND SANITIZER (ALCOHOL) GEL [CADENCE KEEN INNOVATIONS, INC.]1Legacy NDC, 3 package rows20200630_a938eb43-b82c-0f5c-e053-2995a90a3308.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1305100ethanol 75 % Topical GelPSNa938eb43-b82c-0f5c-e053-2995a90a33081
1305100ethanol 0.75 ML/ML Topical GelSCDa938eb43-b82c-0f5c-e053-2995a90a33081
1305100ethanol 75 % Topical GelSYa938eb43-b82c-0f5c-e053-2995a90a33081

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
79128-000-017912800000150 mL in 1 BOTTLE (79128-000-01) 50 ml2020-06-220000-00-00NoNoCurrent
79128-000-1679128000016500 mL in 1 BOTTLE (79128-000-16) 500 ml2020-06-220000-00-00NoNoCurrent
79128-000-37791280000373785 mL in 1 DRUM (79128-000-37) 3785 ml2020-06-220000-00-00NoNoCurrent