Ethanol Monotonic Disinfectant

Product NDC
54983-001
Requested package NDC
54983-001-01
11-digit product format
549830001
Labeler code
54983
Product ID
54983-001_a3045ec7-ea3b-f433-e053-2995a90af7d8
Type
HUMAN OTC DRUG
Nonproprietary name
Ethanol Monotonic Disinfectan
Dosage form
LIQUID
Route
EXTRACORPOREAL
Labeler
Zhejiang Tengyu New Material Technology Co., Ltd.
Application
part333E
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2020-04-08
Marketing end
0000-00-00
Substance
ALCOHOL
Active strength
75 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 packagepackage54983-00154983-001-01IInactivated 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, 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#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
54983-001-012022-01-28C16284748780-1d6a99b39-bd18-a426-e053-dadaa90af4c2a2c54d49-a6a8-42d4-e053-2a95a90add18

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54983-001-01Ethanol Monotonic Disinfectant100 mL in 1 BOTTLELIQUID1003

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54983-001ETHANOL MONOTONIC DISINFECTANT (ETHANOL MONOTONIC DISINFECTAN) LIQUID [ZHEJIANG TENGYU NEW MATERIAL TECHNOLOGY CO., LTD.]3Legacy NDC, 1 package rows20200412_a2c54d49-a6a8-42d4-e053-2a95a90add18.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1047755ethanol 75 % Topical SolutionPSNa2c54d49-a6a8-42d4-e053-2a95a90add183
1047755ethanol 0.75 ML/ML Topical SolutionSCDa2c54d49-a6a8-42d4-e053-2a95a90add183
1047755ethanol 75 % Topical SolutionSYa2c54d49-a6a8-42d4-e053-2a95a90add183

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
54983-001-0154983000101100 mL in 1 BOTTLE (54983-001-01) 100 ml2020-04-080000-00-00NoNoCurrent