Home NDC 58443-0234-4 Defense Zone
Product NDC 58443-0234
Requested package NDC 58443-0234-4
11-digit product format 584430234
Labeler code 58443
Product ID 58443-0234_9c5964a8-114a-17be-e053-2a95a90a68ce
Type HUMAN OTC DRUG
Nonproprietary name Avobenzone, Homosalate, Octisalate, Octocrylene, Oxybenzone
Dosage form LOTION
Route TOPICAL
Labeler Prime Enterprises Inc.
Application part352
Marketing category OTC MONOGRAPH FINAL
Marketing start 2016-05-13
Marketing end 0000-00-00
Substance OXYBENZONE; AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE
Active strength 60 mg/mL; mg/mL; mg/mL; mg/mL; mg/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 · 1 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 2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 58443-0234 58443-0234-4 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 58443-0234-4 58443023404 235 mL in 1 BOTTLE (58443-0234-4) 235 ml 2016-05-13 0000-00-00 No No Current