Smart ANTISEPTIC HAND SANITIZER

Product NDC
78826-100
Requested package NDC
78826-100-50
11-digit product format
788260100
Labeler code
78826
Product ID
78826-100_c7637425-e9d7-4334-aa62-0624d852508e
Type
HUMAN OTC DRUG
Nonproprietary name
Ethyl alcohol
Dosage form
GEL
Route
TOPICAL
Labeler
OZDEN KIMYA VE PLASTIK SANAYI TICARET ANONIM SIRKETI
Application
part333A
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2020-06-29
Marketing end
0000-00-00
Substance
ALCOHOL
Active strength
71 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 packagepackage78826-10078826-100-50IInactivated by FDA2026-10-12

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, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-288af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-081332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-0886f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01bd6a592717d7…303034d00443…

Reported adverse events (FAERS/openFDA)#

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

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
78826-100-50Smart ANTISEPTIC HAND SANITIZER50 mL in 1 BOTTLEGEL501
78826-100-51Smart ANTISEPTIC HAND SANITIZER100 mL in 1 BOTTLEGEL1001
78826-100-52Smart ANTISEPTIC HAND SANITIZER250 mL in 1 BOTTLEGEL2501
78826-100-53Smart ANTISEPTIC HAND SANITIZER500 mL in 1 BOTTLEGEL5001
78826-100-54Smart ANTISEPTIC HAND SANITIZER1000 mL in 1 BOTTLEGEL10001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
78826-100SMART ANTISEPTIC HAND SANITIZER (ETHYL ALCOHOL) GEL [OZDEN KIMYA VE PLASTIK SANAYI TICARET ANONIM SIRKETI]1Legacy NDC, 5 package rows20200704_64eb1523-c746-4010-b55f-e43faa756617.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2282911ethanol 71 % Topical GelPSN64eb1523-c746-4010-b55f-e43faa7566171
2282911ethanol 0.71 ML/ML Topical GelSCD64eb1523-c746-4010-b55f-e43faa7566171
2282911ethanol 71 % Topical GelSY64eb1523-c746-4010-b55f-e43faa7566171

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
78826-100-507882601005050 mL in 1 BOTTLE (78826-100-50) 50 ml2020-06-290000-00-00NoNoCurrent