FDA.reportPublic FDA data

SENEXON

Product NDC
71610-058
Requested package NDC
71610-058-65
11-digit product format
716100058
Labeler code
71610
Product ID
71610-058_81c8d20a-3679-423a-8916-a1e5dcde0fbf
Type
HUMAN OTC DRUG
Nonproprietary name
SENNA
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
part334
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2006-02-09
Marketing end
0000-00-00
Substance
SENNOSIDES A AND B
Active strength
9 mg/1
NDC exclude flag
No
Listing certified through
2020-12-31
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 packagepackage71610-05871610-058-65DDiscontinued by firm2026-10-12

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
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage71610-05871610-058-65DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage71610-05871610-058-65DDiscontinued by firmexcluded / ndc_excluded.zipf5e01cc5f278…a2eaf40c39c3…

Reported adverse events (FAERS/openFDA)#

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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71610-058-65EA - Each71610-0583635cafc-b9e2-44c2-972c-5c0a351ef8b512018-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71610-058SENEXON (SENNA) TABLET, COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1Legacy NDC20180620_18c77552-9e65-4e73-9e41-59f91075ce94.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71610-058-6571610005865100 TABLET, COATED in 1 BOTTLE, PLASTIC (71610-058-65) 2018-05-040000-00-00NoNoCurrent