Home NDC 58418-119-08 Hand Sanitizer with Additive
Product NDC 58418-119
Requested package NDC 58418-119-08
11-digit product format 584180119
Labeler code 58418
Product ID 58418-119_b7c7d5cd-a295-8898-e053-2995a90a482c
Type HUMAN OTC DRUG
Nonproprietary name Hand Sanitizer with Additive
Dosage form GEL
Route TOPICAL
Labeler Tropical Enterprises International, Inc.
Application part333E
Marketing category OTC MONOGRAPH NOT FINAL
Marketing start 2020-05-01
Marketing end 0000-00-00
Substance ALCOHOL
Active strength 20 mL/30mL
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…
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 NDC Product Description Form Quantity Strength SPL version 58418-119-08 Hand Sanitizer with Additive 240 mL in 1 BOTTLE, PUMP GEL 240 1 58418-119-64 Hand Sanitizer with Additive 3840 mL in 1 BOTTLE, PUMP GEL 3840 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 58418-119 HAND SANITIZER WITH ADDITIVE GEL [TROPICAL ENTERPRISES INTERNATIONAL, INC.] 1 Legacy NDC, 2 package rows 20210101_b7c7d5cd-a294-8898-e053-2995a90a482c.zip
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 58418-119-08 58418011908 240 mL in 1 BOTTLE, PUMP (58418-119-08) 240 ml 2020-05-01 0000-00-00 No No Current