FDA.reportPublic FDA data

Hand Sanitizer

Product NDC
71927-009
Requested package NDC
71927-009-01
11-digit product format
719270009
Labeler code
71927
Product ID
71927-009_a47a303a-7ee9-2759-e053-2995a90a4960
Type
HUMAN OTC DRUG
Nonproprietary name
ETHYL ALCOHOL
Dosage form
GEL
Route
TOPICAL
Labeler
Orazen Inc.
Application
part333E
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2020-04-30
Marketing end
0000-00-00
Substance
ALCOHOL
Active strength
70 mL/100mL
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

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 packagepackage71927-00971927-009-01IInactivated by FDA2026-10-05

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 9 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Code, Status table
Captured / source dateCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31UExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20UExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10UExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71927-009-012025-01-30C16284748780-12cef2736-7182-d83d-e063-dadaa90ab31fa47a302d-c7b9-5286-e053-2a95a90aaab2

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71927-009-01Hand Sanitizer236 mL in 1 BOTTLEGEL2361

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71927-009HAND SANITIZER (ETHYL ALCOHOL) GEL [ORAZEN INC.]1Legacy NDC, 1 package rows20200430_a47a302d-c7b9-5286-e053-2a95a90aaab2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
581662ethanol 70 % Topical GelPSNa47a302d-c7b9-5286-e053-2a95a90aaab21
581662ethanol 0.7 ML/ML Topical GelSCDa47a302d-c7b9-5286-e053-2a95a90aaab21
581662ethanol 70 % Topical GelSYa47a302d-c7b9-5286-e053-2a95a90aaab21
581662ethyl alcohol 70 % Topical GelSYa47a302d-c7b9-5286-e053-2a95a90aaab21

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71927-009-0171927000901236 mL in 1 BOTTLE (71927-009-01) 236 ml2020-04-300000-00-00NoNoCurrent