Senna Tabs

Product NDC
16103-363
11-digit product format
161030363
Labeler code
16103
Product ID
16103-363_61f99f78-d945-4004-a167-f3a80979f4a4
Type
HUMAN OTC DRUG
Nonproprietary name
Senna
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Pharbest Pharmaceuticals, Inc.
Application
M007
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2018-09-03
Substance
SENNOSIDES A AND B
Active strength
8.6 mg/1
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

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 · 27 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductIInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage16103-363-08IInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage16103-363-11IInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproductIInactivated by FDA367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage16103-363-08IInactivated by FDA367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage16103-363-11IInactivated by FDA367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproductIInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage16103-363-08IInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage16103-363-11IInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproductIInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage16103-363-08IInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage16103-363-11IInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproductIInactivated by FDA834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage16103-363-08IInactivated by FDA834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage16103-363-11IInactivated by FDA834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproductIInactivated by FDA1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage16103-363-08IInactivated by FDA1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage16103-363-11IInactivated by FDA1332a3947898…d4bfe170f9cd…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproductIInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage16103-363-08IInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage16103-363-11IInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproductIInactivated by FDA9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage16103-363-08IInactivated by FDA9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage16103-363-11IInactivated by FDA9bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproductEExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage16103-363-08EExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage16103-363-11EExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
Senna Tabs
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SENNOSIDES A AND B8.6 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1B5FPI42ENInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
312935Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
b9f8ea59-932f-4827-a87c-b4aff909c43fAvailable on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
16103-363-082024-12-31Drug Facts
16103-363-112024-12-31Drug Facts
16103-363-082023-01-30Drug Facts
16103-363-112023-01-30Drug Facts
16103-363-082021-03-27Drug Facts
16103-363-112021-03-27Drug Facts
16103-363-082020-01-31Drug Facts
16103-363-112020-01-31Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
16103-363-08Senna Tabs100 in 1 BOTTLE, PLASTICTABLET, FILM COATED1004
16103-363-11Senna Tabs1000 in 1 BOTTLE, PLASTICTABLET, FILM COATED10004

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16103-363-08EA - Each16103-363d1c46bcd-5c41-4cf5-a0d1-def0b83c46da12012-07-24
16103-363-11EA - Each16103-36352f694b3-25f1-401c-a42d-b8750a77e2a612012-07-24

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16103-363SENNA TABS (SENNA) TABLET, FILM COATED [PHARBEST PHARMACEUTICALS, INC.]3Current NDC, Legacy NDC, 2 package rows20250101_b9f8ea59-932f-4827-a87c-b4aff909c43f.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 31 of 42 · 833 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Rite Aid Stool SoftenerDOCUSATE CALCIUMRite Aid281b2bc7-4980-4205-a33f-cb1974af8d062024-12-18WarningsExact identifier
application number: M007
Topcare Stool SoftenerDOCUSATE SODIUMTOPCO ASSOCIATES LLC93158bd3-c830-4b12-ab1c-133a4bdb9c782024-12-18WarningsExact identifier
application number: M007
HEB Stool SoftenerDOCUSATE SODIUMH E Bafc54b8e-03d9-418c-9322-97d68f9290312024-12-18WarningsExact identifier
application number: M007
Foster and Thrive Gentle LaxativeBISACODYLStrategic Sourcing Services LLCd03c2c42-d9d9-4b4b-a6ae-31d99425a2282024-12-18WarningsExact identifier
application number: M007
EX-LAX REGULAR STRENGTH CHOCOLATED STIMULANT LAXATIVESENNOSIDESHaleon US Holdings LLC59a26a7f-516f-4507-8dec-f40cf6cfaffc2024-12-17WarningsExact identifier
application number: M007
EX-LAX MAXIMUM STRENGTH STIMULANT LAXATIVESENNOSIDESHaleon US Holdings LLCfb170340-c996-46cf-b165-84e136ba41512024-12-17WarningsExact identifier
application number: M007
Senna SyrupNATURAL VEGETABLE LAXATIVEBryant Ranch Prepack7d1f092e-0e5b-4fed-a095-64449751582d2024-12-16WarningsExact identifier
application number: M007
Drug Mart Vegetable Laxative plus Stool SoftenerDOCUSATE SODIUM, SENNOSIDESDiscount Drug Mart, Inc1b6d59e8-112f-447f-b6e9-526b7d3bd01e2024-12-13WarningsExact identifier
application number: M007
Drug Mart Stool Softener plus Stimulant LaxativeDOCUSATE SODIUM, SENNOSIDESDiscount Drug Mart, Inccaf74258-922c-4b69-9bd6-57b3e918c7a62024-12-13WarningsExact identifier
application number: M007
Docusate SodiumDOCUSATE SODIUMNational Vitamin Company0c66642c-82cb-42cd-82bb-5f95852cc5d12024-12-12WarningsExact identifier
application number: M007
Foster and Thrive Fiber Laxative 147CALCIUM POLYCARBOPHILStrategic Sourcing Services LLC88d341a6-28aa-4a20-bfed-1d5f3106c2ae2024-12-12WarningsExact identifier
application number: M007
Pedia-LaxSODIUM PHOSPHATE, DIBASIC AND SODIUM PHOSPHATE, MONOBASICC.B. Fleet Company, Inc.f001a37d-8ed4-428b-af12-d6a83c22c1272024-12-12WarningsExact identifier
application number: M007
Careone Milk of magnesia Original Milk of Magnesia OriginalMAGNESIUM HYDROXIDERetail Business Services, LLC.13ffb00b-7c6f-47aa-bc82-2402d121a7582024-12-11WarningsExact identifier
application number: M007
CareOne Milk of Magnesia CherryMAGNESIUM HYDROXIDERetail Business Services, LLC.1822f90d-f693-48d7-b338-a3f2ddfac4df2024-12-11WarningsExact identifier
application number: M007
MILK OF MAGNESIA MINTMAGNESIUM HYDROXIDEGOOD SENSEa951b6d0-9182-e1bc-e053-2a95a90a12b12024-12-09WarningsExact identifier
application number: M007
SennosidesSENNOSIDESMajor Pharmaceuticalsdf3b431b-a1ad-91dd-e053-2995a90aa02f2024-12-06WarningsExact identifier
application number: M007
milk of magnesiaMAGNESIUM HYDROXIDECVS Pharmacyb3a36251-edd6-4201-8da1-85d7a6ede1732024-12-05WarningsExact identifier
application number: M007
CITRUCELMETHYLCELLULOSEHaleon US Holdings LLCd27f6742-2dcc-451e-b803-6ffe183038ec2024-12-05WarningsExact identifier
application number: M007
LaxacinDOCUSATE SODIUM AND SENNOSIDESAlexso, Inc0df9abaf-3997-4dde-8003-ae3d8d07cf392024-12-04WarningsExact identifier
application number: M007
NuValu Epsom SaltMAGNESIUM SULFATE (HEPTAHYDRATE)J C SALES9f3cf9a4-e5c0-41ff-9fd3-63efb0d973cd2024-12-04WarningsExact identifier
application number: M007

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312935sennosides 8.6 MG Oral TabletPSN2b03d07c-ea4f-4663-bcc3-20ebdf83b7aa9
312935sennosides, USP 8.6 MG Oral TabletSCD2b03d07c-ea4f-4663-bcc3-20ebdf83b7aa9
312935sennosides A and B 8.6 MG Oral TabletSY2b03d07c-ea4f-4663-bcc3-20ebdf83b7aa9
312935sennosides 8.6 MG Oral TabletPSNb9f8ea59-932f-4827-a87c-b4aff909c43f4
312935sennosides, USP 8.6 MG Oral TabletSCDb9f8ea59-932f-4827-a87c-b4aff909c43f4
312935sennosides A and B 8.6 MG Oral TabletSYb9f8ea59-932f-4827-a87c-b4aff909c43f4
312935sennosides 8.6 MG Oral TabletPSNcd6e3fb4-0c5a-4aa7-89ea-109c6d072efe3
312935sennosides, USP 8.6 MG Oral TabletSCDcd6e3fb4-0c5a-4aa7-89ea-109c6d072efe3
312935sennosides A and B 8.6 MG Oral TabletSYcd6e3fb4-0c5a-4aa7-89ea-109c6d072efe3
312935sennosides 8.6 MG Oral TabletPSNbcf5bc3f-60c8-bfd7-e053-2a95a90a97a71
312935sennosides, USP 8.6 MG Oral TabletSCDbcf5bc3f-60c8-bfd7-e053-2a95a90a97a71
312935sennosides A and B 8.6 MG Oral TabletSYbcf5bc3f-60c8-bfd7-e053-2a95a90a97a71

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
16103-363-0816103036308100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (16103-363-08) 2018-09-030000-00-00NoNoCurrent
16103-363-11161030363111000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (16103-363-11) 2018-09-030000-00-00NoNoCurrent