Home NDC 0395-0129 Castiva Cooling
Product NDC 0395-0129
11-digit product format 003950129
Labeler code 0395
Product ID 0395-0129_a87209ef-91a0-211f-e053-2a95a90a602d
Type HUMAN OTC DRUG
Nonproprietary name Menthol and Methyl Salicylate
Dosage form CREAM
Route TOPICAL
Labeler Humco Holding Group, Inc.
Application part348
Marketing category OTC MONOGRAPH NOT FINAL
Marketing start 2006-12-01
Marketing end 0000-00-00
Substance MENTHOL; METHYL SALICYLATE
Active strength 50 mg/g; mg/g
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 · 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 2022-08-30 03:57 UTC · source 2022-08-29 excluded product product 0395-0129 I Inactivated by FDA excluded / ndc_excluded.zip fb8cb913e6d1…eb8c232b6be0…2022-08-30 03:57 UTC · source 2022-08-29 excluded package package 0395-0129 0395-0129-94 I Inactivated by FDA excluded / ndc_excluded.zip fb8cb913e6d1…eb8c232b6be0…
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 0395-0129-94 00395012994 1 TUBE in 1 CARTON (0395-0129-94) > 113 g in 1 TUBE 1 tube 2006-12-01 0000-00-00 No No Current