Home NDC 80400-001-01 Hand Sanitizer 80ml
Product NDC 80400-001
Requested package NDC 80400-001-01
11-digit product format 804000001
Labeler code 80400
Product ID 80400-001_ae5fba48-2572-dc87-e053-2995a90a4fd8
Type HUMAN OTC DRUG
Nonproprietary name Hand Sanitizer
Dosage form GEL, METERED
Route TOPICAL
Labeler NEW ZEALAND UNITED PHARMACEUTICALS LIMITED
Application part333A
Marketing category OTC MONOGRAPH NOT FINAL
Marketing start 2020-08-01
Marketing end 0000-00-00
Substance ALCOHOL
Active strength 59 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…
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 80400-001-01 Hand Sanitizer 80ml 80 mL in 1 BOTTLE, PLASTIC GEL, METERED 80 1 80400-001-02 Hand Sanitizer 80ml 500 mL in 1 BOTTLE, PLASTIC GEL, METERED 500 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 80400-001 HAND SANITIZER 80ML (HAND SANITIZER) GEL, METERED [NEW ZEALAND UNITED PHARMACEUTICALS LIMITED] 1 Legacy NDC, 1 package rows 20200903_ae660f0f-c8f0-b13b-e053-2a95a90a6cba.zip 80400-001 HAND SANITIZER 80ML (HAND SANITIZER) GEL, METERED [NEW ZEALAND UNITED PHARMACEUTICALS LIMITED] 1 Legacy NDC, 1 package rows 20200903_ae5ff2ca-52c6-01c1-e053-2a95a90a751e.zip
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 80400-001-01 80400000101 80 mL in 1 BOTTLE, PLASTIC (80400-001-01) 80 ml 2020-08-01 0000-00-00 Yes No Current