Home NDC 71241-002-99 BIOCORNEUM ADVANCED SCAR TREATMENT ANTI-ITCH
Product NDC 71241-002
Requested package NDC 71241-002-99
11-digit product format 712410002
Labeler code 71241
Product ID 71241-002_b8ab3acc-d508-1454-e053-2995a90ad733
Type HUMAN OTC DRUG
Nonproprietary name Hydrocortisone acetate 1%
Dosage form GEL
Route TOPICAL
Labeler Sientra, Inc.
Application part348
Marketing category OTC MONOGRAPH NOT FINAL
Marketing start 2018-05-08
Marketing end 0000-00-00
Substance HYDROCORTISONE ACETATE
Active strength 1 g/100g
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 71241-002 71241-002-99 I Inactivated by FDA excluded / ndc_excluded.zip 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 71241-002 71241-002-99 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 Marketing start Marketing end Sample Exclude flag Status 71241-002-99 71241000299 1 BOTTLE, PUMP in 1 CARTON (71241-002-99) > 5 g in 1 BOTTLE, PUMP (71241-002-05) 2018-05-08 0000-00-00 No No Current