Home NDC 80284-000-03 Exgerm Antiseptic Hand Sanitizer
Product NDC 80284-000
Requested package NDC 80284-000-03
11-digit product format 802840000
Labeler code 80284
Product ID 80284-000_addfd052-2cbb-59e8-e053-2a95a90a0bc1
Type HUMAN OTC DRUG
Nonproprietary name ISOPROPYL ALCOHOL
Dosage form LIQUID
Route TOPICAL
Labeler International Biotech Factory, S.A. de C.V.
Application part333E
Marketing category OTC MONOGRAPH NOT FINAL
Marketing start 2020-08-20
Marketing end 0000-00-00
Substance ISOPROPYL ALCOHOL
Active strength 1 mL/mL
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 · 9 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 U Excluded because listing certification expired 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 U Excluded because listing certification expired ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 U Excluded because listing certification expired 0efc9e666f02…f202fb6c5f17…
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 80284-000-01 Exgerm Antiseptic Hand Sanitizer 60 mL in 1 BOTTLE LIQUID 60 2 80284-000-02 Exgerm Antiseptic Hand Sanitizer 250 mL in 1 BOTTLE LIQUID 250 2 80284-000-03 Exgerm Antiseptic Hand Sanitizer 500 mL in 1 BOTTLE LIQUID 500 2 80284-000-04 Exgerm Antiseptic Hand Sanitizer 1000 mL in 1 BOTTLE LIQUID 1000 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 80284-000 EXGERM ANTISEPTIC HAND SANITIZER (ISOPROPYL ALCOHOL) LIQUID [INTERNATIONAL BIOTECH FACTORY, S.A. DE C.V.] 2 Legacy NDC, 4 package rows 20231221_addf6a21-5c0e-59e2-e053-2a95a90a7080.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 80284-000-03 80284000003 500 mL in 1 BOTTLE (80284-000-03) 500 ml 2020-08-20 0000-00-00 No No Current