BIOCORNEUM ADVANCED SCAR TREATMENT ANTI-ITCH

Product NDC
71241-002
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 · 4 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage71241-002-99834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage71241-002-991332a3947898…d4bfe170f9cd…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71241-002-992024-01-30C16284748780-11030e365-3c81-111a-e063-dadaa90a10e2Drug Facts

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71241-002-99712410002991 BOTTLE, PUMP in 1 CARTON (71241-002-99) > 5 g in 1 BOTTLE, PUMP (71241-002-05) 2018-05-080000-00-00NoNoCurrent