I D ANTI BACTERIAL ALCOHOL BASED HAND DISINFECTANT

Product NDC
78992-611
Requested package NDC
78992-611-01
11-digit product format
789920611
Labeler code
78992
Product ID
78992-611_a93c7cf4-03f7-279a-e053-2a95a90aa4e3
Type
HUMAN OTC DRUG
Nonproprietary name
ALCOHOL
Dosage form
GEL
Route
TOPICAL
Labeler
DTH SAGLIK HIZMETLERI TICARET ANONIM SIRKETI
Application
part333A
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2020-03-30
Marketing end
0000-00-00
Substance
ISOPROPYL ALCOHOL; ALCOHOL
Active strength
1 mL/100mL; 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 packagepackage78992-61178992-611-01IInactivated 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 · 18 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 2025-01-31IInactivated by FDA302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20IInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10IInactivated by FDA0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08IInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03IInactivated by FDA367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09IInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28IInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14IInactivated by FDA834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08IInactivated by FDA1332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29IInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08UExcluded because listing certification expired86f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01UExcluded because listing certification expiredbd6a592717d7…303034d00443…

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
78992-611-012022-07-29C16284748780-1e4f33bdf-9f68-d8a0-e053-dadaa90a6e4eHand Sanitizer Gel
78992-611-022022-07-29C16284748780-1e4f33bdf-9f68-d8a0-e053-dadaa90a6e4eHand Sanitizer Gel
78992-611-032022-07-29C16284748780-1e4f33bdf-9f68-d8a0-e053-dadaa90a6e4eHand Sanitizer Gel

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
78992-611-01I D ANTI BACTERIAL ALCOHOL BASED HAND DISINFECTANT5 mL in 1 BOTTLE, PLASTICGEL51
78992-611-02I D ANTI BACTERIAL ALCOHOL BASED HAND DISINFECTANT500 mL in 1 BOTTLE, PLASTICGEL5001
78992-611-03I D ANTI BACTERIAL ALCOHOL BASED HAND DISINFECTANT1000 mL in 1 BOTTLE, PLASTICGEL10001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
78992-611I D ANTI BACTERIAL ALCOHOL BASED HAND DISINFECTANT (ALCOHOL) GEL [DTH SAGLIK HIZMETLERI TICARET ANONIM SIRKETI]1Legacy NDC, 3 package rows20200701_a93c7cf4-0405-279a-e053-2a95a90aa4e3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2381735ethanol 70 % / isopropyl alcohol 0.5 % Topical GelPSNa93c7cf4-0405-279a-e053-2a95a90aa4e31
2381735ethanol 0.7 ML/ML / isopropyl alcohol 0.005 ML/ML Topical GelSCDa93c7cf4-0405-279a-e053-2a95a90aa4e31
2381735ethanol 70 % / isopropyl alcohol 0.5 % Topical GelSYa93c7cf4-0405-279a-e053-2a95a90aa4e31

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
78992-611-01789920611015 mL in 1 BOTTLE, PLASTIC (78992-611-01) 5 ml2020-03-300000-00-00NoNoCurrent