Home NDC 58418-116-15 Hand Sanitizer
Product NDC 58418-116
Requested package NDC 58418-116-15
11-digit product format 584180116
Labeler code 58418
Product ID 58418-116_9da604db-9825-b2bc-e053-2a95a90a9646
Type HUMAN OTC DRUG
Nonproprietary name Hand Sanitizer
Dosage form GEL
Route TOPICAL
Labeler Tropical Enterprises International, Inc.
Application part333E
Marketing category OTC MONOGRAPH NOT FINAL
Marketing start 2012-08-01
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 58418-116-00 Hand Sanitizer 10 mL in 1 PACKET GEL 10 5 58418-116-01 Hand Sanitizer 30 mL in 1 BOTTLE, PLASTIC GEL 30 5 58418-116-02 Hand Sanitizer 60 mL in 1 BOTTLE, PLASTIC GEL 60 5 58418-116-04 Hand Sanitizer 120 mL in 1 BOTTLE, PLASTIC GEL 120 5 58418-116-05 Hand Sanitizer 15 mL in 1 BOTTLE, PLASTIC GEL 15 5 58418-116-08 Hand Sanitizer 240 mL in 1 BOTTLE, PUMP GEL 240 5 58418-116-09 Hand Sanitizer 240 mL in 1 BOTTLE, DISPENSING GEL 240 5 58418-116-10 Hand Sanitizer 10 mL in 1 BOTTLE, SPRAY GEL 10 5 58418-116-12 Hand Sanitizer 360 mL in 1 BOTTLE, PUMP GEL 360 5 58418-116-15 Hand Sanitizer 45 mL in 1 BOTTLE, DISPENSING GEL 45 5 58418-116-16 Hand Sanitizer 480 mL in 1 BOTTLE, PUMP GEL 480 5 58418-116-18 Hand Sanitizer 52 mL in 1 BOTTLE, DISPENSING GEL 52 5 58418-116-25 Hand Sanitizer 960000 mL in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULK GEL 960000 5 58418-116-28 Hand Sanitizer 840 mL in 1 BOTTLE, PUMP GEL 840 5 58418-116-32 Hand Sanitizer 1228800 mL in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULK GEL 1228800 5 58418-116-55 Hand Sanitizer 30 mL in 1 BOTTLE, DISPENSING GEL 30 5 58418-116-64 Hand Sanitizer 1920 mL in 1 BOTTLE, PUMP GEL 1920 5 58418-116-70 Hand Sanitizer 211200 mL in 1 DRUM GEL 211200 5 58418-116-99 Hand Sanitizer 3840 mL in 1 JUG GEL 3840 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 58418-116 HAND SANITIZER GEL [TROPICAL ENTERPRISES INTERNATIONAL, INC.] 5 Legacy NDC, 19 package rows 20200716_6e013ae7-955c-9d9c-e053-2991aa0a2767.zip
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 58418-116-15 58418011615 45 mL in 1 BOTTLE, DISPENSING (58418-116-15) 45 ml 2020-02-02 0000-00-00 No No Current