BIOCORNEUM PLUS BROAD SPECTRUM SPF 30 ADVANCED SCAR TREATMENT

Product NDC
71241-003
Requested package NDC
71241-003-99
11-digit product format
712410003
Labeler code
71241
Product ID
71241-003_ea798eb6-187d-9d98-e053-2995a90a7af0
Type
HUMAN OTC DRUG
Nonproprietary name
BIOCORNEUM PLUS BROAD SPECTRUM SPF 30 ADVANCED SCAR TREATMENT
Dosage form
GEL
Route
TOPICAL
Labeler
Sientra, Inc
Application
part352
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2020-03-31
Marketing end
0000-00-00
Substance
AVOBENZONE; HOMOSALATE; MERADIMATE; OCTISALATE; OCTOCRYLENE
Active strength
3 g/100g; g/100g; g/100g; g/100g; g/100g
NDC exclude flag
No
Listing certified through
2023-12-31
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 dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage71241-00371241-003-99IInactivated by FDAexcluded / ndc_excluded.zip834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage71241-00371241-003-99IInactivated by FDAexcluded / ndc_excluded.zip1332a3947898…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
71241-003-962024-01-30C16284748780-11030e365-1449-111a-e063-dadaa90a10e2Drug Facts
71241-003-982024-01-30C16284748780-11030e365-3a4a-111a-e063-dadaa90a10e2Drug Facts
71241-003-992024-01-30C16284748780-11030e365-51c2-111a-e063-dadaa90a10e2Drug Facts

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71241-003-99712410003991 BOTTLE, PUMP in 1 CARTON (71241-003-99) > 50 g in 1 BOTTLE, PUMP (71241-003-50) 2020-03-310000-00-00NoNoCurrent