Antibacterial Hand Disinfectant Solution

Product NDC
78433-201
Requested package NDC
78433-201-08
11-digit product format
784330201
Labeler code
78433
Product ID
78433-201_2183defb-dbf4-4eb1-b76a-d66635655d0f
Type
HUMAN OTC DRUG
Nonproprietary name
Ethyl alcohol
Dosage form
LIQUID
Route
TOPICAL
Labeler
KOCKAR MAKINA KIMYA SANAYI VE TICARET ANONIM SIRKETI
Application
part333A
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2020-07-21
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 packagepackage78433-20178433-201-08IInactivated 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 · 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
78433-201-01Antibacterial Hand Disinfectant Solution5 mL in 1 BOTTLELIQUID51
78433-201-02Antibacterial Hand Disinfectant Solution10 mL in 1 BOTTLELIQUID101
78433-201-03Antibacterial Hand Disinfectant Solution50 mL in 1 BOTTLELIQUID501
78433-201-04Antibacterial Hand Disinfectant Solution100 mL in 1 BOTTLELIQUID1001
78433-201-05Antibacterial Hand Disinfectant Solution200 mL in 1 BOTTLELIQUID2001
78433-201-06Antibacterial Hand Disinfectant Solution250 mL in 1 BOTTLELIQUID2501
78433-201-07Antibacterial Hand Disinfectant Solution500 mL in 1 BOTTLELIQUID5001
78433-201-08Antibacterial Hand Disinfectant Solution750 mL in 1 BOTTLELIQUID7501
78433-201-09Antibacterial Hand Disinfectant Solution1000 mL in 1 BOTTLELIQUID10001
78433-201-10Antibacterial Hand Disinfectant Solution5000 mL in 1 BOTTLELIQUID50001
78433-201-11Antibacterial Hand Disinfectant Solution20000 mL in 1 CONTAINERLIQUID200001
78433-201-12Antibacterial Hand Disinfectant Solution1000000 mL in 1 CONTAINERLIQUID10000001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
78433-201ANTIBACTERIAL HAND DISINFECTANT SOLUTION (ETHYL ALCOHOL) LIQUID [KOCKAR MAKINA KIMYA SANAYI VE TICARET ANONIM SIRKETI]1Legacy NDC, 12 package rows20200805_161c2319-71b6-44ba-b45d-c5a191a200db.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
582753ethanol 70 % Topical SolutionPSN161c2319-71b6-44ba-b45d-c5a191a200db1
582753ethanol 0.7 ML/ML Topical SolutionSCD161c2319-71b6-44ba-b45d-c5a191a200db1
582753ethanol 70 % Topical SolutionSY161c2319-71b6-44ba-b45d-c5a191a200db1
582753ethyl alcohol 70 % Topical SolutionSY161c2319-71b6-44ba-b45d-c5a191a200db1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
78433-201-0878433020108750 mL in 1 BOTTLE (78433-201-08) 750 ml2020-07-210000-00-00NoNoCurrent