ANTISEPTIC HAND SANITIZER

Product NDC
78433-101
Requested package NDC
78433-101-06
11-digit product format
784330101
Labeler code
78433
Product ID
78433-101_a981dc46-3c36-4f3d-80a9-691747e50800
Type
HUMAN OTC DRUG
Nonproprietary name
Ethyl alcohol
Dosage form
GEL
Route
TOPICAL
Labeler
KOCKAR MAKINA KIMYA SANAYI VE TICARET ANONIM SIRKETI
Application
part333A
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2020-07-07
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 packagepackage78433-10178433-101-06IInactivated 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 · 19 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…
2021-12-27 23:28 UTC · source 2021-12-278dfbde2a14a4…c9ff85d89658…

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
78433-101-01ANTISEPTIC HAND SANITIZER5 mL in 1 BOTTLEGEL51
78433-101-02ANTISEPTIC HAND SANITIZER10 mL in 1 BOTTLEGEL101
78433-101-03ANTISEPTIC HAND SANITIZER50 mL in 1 BOTTLEGEL501
78433-101-04ANTISEPTIC HAND SANITIZER100 mL in 1 BOTTLEGEL1001
78433-101-05ANTISEPTIC HAND SANITIZER200 mL in 1 BOTTLEGEL2001
78433-101-06ANTISEPTIC HAND SANITIZER250 mL in 1 BOTTLEGEL2501
78433-101-07ANTISEPTIC HAND SANITIZER500 mL in 1 BOTTLEGEL5001
78433-101-08ANTISEPTIC HAND SANITIZER750 mL in 1 BOTTLEGEL7501
78433-101-09ANTISEPTIC HAND SANITIZER1000 mL in 1 BOTTLEGEL10001
78433-101-10ANTISEPTIC HAND SANITIZER5000 mL in 1 BOTTLEGEL50001
78433-101-11ANTISEPTIC HAND SANITIZER20000 mL in 1 CONTAINERGEL200001
78433-101-12ANTISEPTIC HAND SANITIZER1000000 mL in 1 CONTAINERGEL10000001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
78433-101ANTISEPTIC HAND SANITIZER (ETHYL ALCOHOL) GEL [KOCKAR MAKINA KIMYA SANAYI VE TICARET ANONIM SIRKETI]1Legacy NDC, 12 package rows20200717_173ccc7a-c7cb-4bb7-9ded-c0cd1be20c8d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
581662ethanol 70 % Topical GelPSN173ccc7a-c7cb-4bb7-9ded-c0cd1be20c8d1
581662ethanol 0.7 ML/ML Topical GelSCD173ccc7a-c7cb-4bb7-9ded-c0cd1be20c8d1
581662ethanol 70 % Topical GelSY173ccc7a-c7cb-4bb7-9ded-c0cd1be20c8d1
581662ethyl alcohol 70 % Topical GelSY173ccc7a-c7cb-4bb7-9ded-c0cd1be20c8d1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
78433-101-0678433010106250 mL in 1 BOTTLE (78433-101-06) 250 ml2020-07-070000-00-00NoNoCurrent