Home NDC 80869-601-04 Hand Sanitizer
Product NDC 80869-601
Requested package NDC 80869-601-04
11-digit product format 808690601
Labeler code 80869
Product ID 80869-601_c2bba84d-e5aa-7b7b-e053-2995a90a08fa
Type HUMAN OTC DRUG
Nonproprietary name Hand Sanitizer Soap
Dosage form GEL
Route TOPICAL
Labeler GMA Supplies LLC
Application part333A
Marketing category OTC MONOGRAPH NOT FINAL
Marketing start 2020-03-30
Marketing end 0000-00-00
Substance BENZALKONIUM CHLORIDE
Active strength 0 g/100mL
NDC exclude flag No
Listing certified through 2022-12-31
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 · 19 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Code, Status table Captured / source date Code Status Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 I Inactivated by FDA 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 I Inactivated by FDA ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 I Inactivated by FDA 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 I Inactivated by FDA ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 I Inactivated by FDA 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 I Inactivated by FDA 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 I Inactivated by FDA 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 I Inactivated by FDA 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 I Inactivated by FDA 1332a3947898…d4bfe170f9cd…2022-08-30 03:57 UTC · source 2022-08-29 I Inactivated by FDA fb8cb913e6d1…eb8c232b6be0…2022-04-09 23:13 UTC · source 2022-04-08 E Excluded after deficient or non-compliant submission was not corrected 86f5da6cb304…a595104c45d7…2022-04-04 05:40 UTC · source 2022-04-01 E Excluded after deficient or non-compliant submission was not corrected bd6a592717d7…303034d00443…2021-12-27 23:28 UTC · source 2021-12-27 E Excluded after deficient or non-compliant submission was not corrected 8dfbde2a14a4…c9ff85d89658…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 80869-601-03 Hand Sanitizer 400 mL in 1 BOTTLE GEL 400 2 80869-601-04 Hand Sanitizer 400 mL in 1 BOTTLE GEL 400 2 80869-601-01 Hand Sanitizer 60 mL in 1 BOTTLE GEL 60 1 80869-601-02 Hand Sanitizer 60 mL in 1 BOTTLE GEL 60 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 80869-601 HAND SANITIZER (HAND SANITIZER SOAP) GEL [GMA SUPPLIES LLC] 2 Legacy NDC, 1 package rows 20210520_b3b480b3-7fde-cf88-e053-2995a90a75a2.zip 80869-601 HAND SANITIZER (HAND SANITIZER SOAP) GEL [GMA SUPPLIES LLC] 2 Legacy NDC, 1 package rows 20210520_b3b39b03-f696-120d-e053-2995a90ad712.zip 80869-601 HAND SANITIZER (HAND SANITIZER SOAP) GEL [GMA SUPPLIES LLC] 1 Legacy NDC, 1 package rows 20210520_c2bb7cb2-669f-6b50-e053-2a95a90aa665.zip 80869-601 HAND SANITIZER (HAND SANITIZER SOAP) GEL [GMA SUPPLIES LLC] 1 Legacy NDC, 1 package rows 20210522_c2bba84d-e5b8-7b7b-e053-2995a90a08fa.zip
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 80869-601-04 80869060104 400 mL in 1 BOTTLE (80869-601-04) 400 ml 2020-03-30 0000-00-00 No No Current