Home NDC 75822-027-03 AMORAY
Product NDC 75822-027
Requested package NDC 75822-027-03
11-digit product format 758220027
Labeler code 75822
Product ID 75822-027_b89d3d0e-6c22-3c50-e053-2a95a90a2f3c
Type HUMAN OTC DRUG
Nonproprietary name ETHYL ALCOHOL
Dosage form AEROSOL, SPRAY
Route TOPICAL
Labeler KOZMO KIMYA SANAYI VE DIS TICARET LIMITED SIRKETI
Application part333A
Marketing category OTC MONOGRAPH NOT FINAL
Marketing start 2020-04-26
Marketing end 0000-00-00
Substance ALCOHOL
Active strength 70 mL/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 · 2 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 75822-027 75822-027-03 I Inactivated by FDA excluded / ndc_excluded.zip 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 75822-027 75822-027-03 I Inactivated by FDA excluded / ndc_excluded.zip 1332a3947898…d4bfe170f9cd…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
FDA-Initiated Inactive NDC Indexing# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 75822-027-03 75822002703 75 mL in 1 CAN (75822-027-03) 75 ml 2020-04-26 0000-00-00 Yes No Current