Home NDC 63931-4315-1 WL-AAA-Z-A-525
Product NDC 63931-4315
Requested package NDC 63931-4315-1
11-digit product format 639314315
Labeler code 63931
Product ID 63931-4315_901ac250-d6d9-2933-e053-2995a90ac726
Type HUMAN OTC DRUG
Nonproprietary name Zinc Oxide
Dosage form LOTION
Route TOPICAL
Labeler Nanophase Technologies Corporation
Application part352
Marketing category OTC MONOGRAPH NOT FINAL
Marketing start 2019-03-26
Marketing end 0000-00-00
Substance ZINC OXIDE
Active strength 130 mg/mL
NDC exclude flag No
Listing certified through 2020-12-31
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 · 4 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 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…
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 63931-4315-1 63931431501 150000 mL in 1 DRUM (63931-4315-1) 150000 ml 2019-03-26 0000-00-00 No No Current