FDA.reportPublic FDA data

ACTS38 BoswelliaGel (100ml)

Product NDC
82967-0002
Requested package NDC
82967-0002-1
11-digit product format
829670002
Labeler code
82967
Product ID
82967-0002_eba83e5c-bb7e-92c1-e053-2995a90a7eb3
Type
HUMAN OTC DRUG
Nonproprietary name
Boswellia Serrata Extract,, Acetyl Glucosamine , Centella Asiatica Extract, Sodium Hyaluronate
Dosage form
GEL
Route
TOPICAL
Labeler
A-Lot Biologics Inc
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2022-10-23
Marketing end
0000-00-00
Substance
CENTELLA ASIATICA; HYALURONATE SODIUM; INDIAN FRANKINCENSE; N-ACETYLGLUCOSAMINE
Active strength
0 g/100mL; g/100mL; g/100mL; g/100mL
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage82967-000282967-0002-1IInactivated by FDA2026-09-14

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 · 9 matching rows.

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

Captured / source date, Code, Status table
Captured / source dateCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31UExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20UExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10UExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…

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
82967-0002-12025-01-30C16284748780-10191ceaa-6ebb-198a-e063-dbdaa90aec3eDrug Facts
82967-0002-12023-10-09C16284748780-10191ceaa-6ebb-198a-e063-dbdaa90aec3eDrug Facts
82967-0002-12023-07-28C16284748780-10191ceaa-6ebb-198a-e063-dbdaa90aec3eDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82967-0002-1ACTS38 BoswelliaGel (100ml)100 mL in 1 TUBEGEL1001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82967-0002ACTS38 BOSWELLIAGEL (100ML) (BOSWELLIA SERRATA EXTRACT,, ACETYL GLUCOSAMINE , CENTELLA ASIATICA EXTRACT, SODIUM HYALURONATE) GEL [A-LOT BIOLOGICS INC]1Legacy NDC, 1 package rows20221023_eba83e5c-bb7d-92c1-e053-2995a90a7eb3.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
82967-0002-182967000201100 mL in 1 TUBE (82967-0002-1) 100 ml2022-10-230000-00-00NoNoCurrent