Home NDC 54345-002-01 Alcohol Antibacterial Gel(None-Rinse)
Product NDC 54345-002
Requested package NDC 54345-002-01
11-digit product format 543450002
Labeler code 54345
Product ID 54345-002_a983fd02-a998-2466-e053-2a95a90a1a74
Type HUMAN OTC DRUG
Nonproprietary name Alcohol
Dosage form GEL
Route TOPICAL
Labeler Amicus Asia Pacific(Hubei) Healthcare Products Pte Ltd
Application part333E
Marketing category OTC MONOGRAPH NOT FINAL
Marketing start 2020-07-03
Marketing end 0000-00-00
Substance ALCOHOL
Active strength 60 mL/80mL
NDC exclude flag No
Listing certified through 2021-12-31
Current FDA listing Historical FDA.report record 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 date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 1332a3947898…d4bfe170f9cd…2022-08-30 03:57 UTC · source 2022-08-29 fb8cb913e6d1…eb8c232b6be0…2022-04-09 23:13 UTC · source 2022-04-08 86f5da6cb304…a595104c45d7…2022-04-04 05:40 UTC · source 2022-04-01 bd6a592717d7…303034d00443…
FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 54345-002-01 Alcohol Antibacterial Gel(None-Rinse) 80 mL in 1 BOTTLE GEL 80 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 54345-002 ALCOHOL ANTIBACTERIAL GEL(NONE-RINSE) (ALCOHOL) GEL [AMICUS ASIA PACIFIC(HUBEI) HEALTHCARE PRODUCTS PTE LTD] 1 Legacy NDC, 1 package rows 20200703_a983fd02-a997-2466-e053-2a95a90a1a74.zip
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 54345-002-01 54345000201 80 mL in 1 BOTTLE (54345-002-01) 80 ml 2020-07-03 0000-00-00 No No Current