Venusamy clean gel

Product NDC
55418-001
Requested package NDC
55418-001-01
11-digit product format
554180001
Labeler code
55418
Product ID
55418-001_a3ee631d-5743-6aaa-e053-2995a90a98cb
Type
HUMAN OTC DRUG
Nonproprietary name
Venusamy clean gel
Dosage form
GEL
Route
EXTRACORPOREAL
Labeler
ELink Technology Co., Ltd.
Application
part333E
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2020-04-23
Marketing end
0000-00-00
Substance
ALCOHOL
Active strength
49 mL/70mL
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 packagepackage55418-00155418-001-01IInactivated 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
55418-001-012022-01-28C16284748780-1d6a99b39-bdf7-a426-e053-dadaa90af4c2a3ee631d-5742-6aaa-e053-2995a90a98cb

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55418-001-01Venusamy clean gel70 mL in 1 BOTTLEGEL701

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55418-001VENUSAMY CLEAN GEL GEL [ELINK TECHNOLOGY CO., LTD.]1Legacy NDC, 1 package rows20200425_a3ee631d-5742-6aaa-e053-2995a90a98cb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
581662ethanol 70 % Topical GelPSNa3ee631d-5742-6aaa-e053-2995a90a98cb1
581662ethanol 0.7 ML/ML Topical GelSCDa3ee631d-5742-6aaa-e053-2995a90a98cb1
581662ethanol 70 % Topical GelSYa3ee631d-5742-6aaa-e053-2995a90a98cb1
581662ethyl alcohol 70 % Topical GelSYa3ee631d-5742-6aaa-e053-2995a90a98cb1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55418-001-015541800010170 mL in 1 BOTTLE (55418-001-01) 70 ml2020-04-230000-00-00NoNoCurrent