Home NDC 13630-0126-4 Miami Beach
Product NDC 13630-0126
Requested package NDC 13630-0126-4
11-digit product format 136300126
Labeler code 13630
Product ID 13630-0126_9c5c68ed-5357-647e-e053-2a95a90a0d3d
Type HUMAN OTC DRUG
Nonproprietary name Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone
Dosage form SPRAY
Route TOPICAL
Labeler Prime Packaging Inc.
Application part352
Marketing category OTC MONOGRAPH FINAL
Marketing start 2018-03-15
Marketing end 0000-00-00
Substance AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE
Active strength 27 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 13630-0126 13630-0126-4 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 13630-0126-4 13630012604 177 mL in 1 CAN (13630-0126-4) 177 ml 2018-03-15 0000-00-00 No No Current