FDA.reportPublic FDA data

Senna-S

Product NDC
16103-378
11-digit product format
161030378
Labeler code
16103
Product ID
16103-378_0783ba51-f52a-4ac9-a5fe-ae0bfb6ef57c
Type
HUMAN OTC DRUG
Nonproprietary name
Sennosides 8.6mg and Docusate Sodium 50mg
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Pharbest Pharmaceuticals, Inc.
Application
M007
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2018-11-05
Substance
SENNOSIDES; DOCUSATE SODIUM
Active strength
8.6; 50 mg/1; 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 · 36 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage16103-378-08ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage16103-378-11ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage16103-378-07ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage16103-378-08367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage16103-378-11367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage16103-378-07367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage16103-378-08557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage16103-378-11557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage16103-378-07557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage16103-378-088af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage16103-378-118af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage16103-378-078af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage16103-378-08834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage16103-378-11834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage16103-378-07834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage16103-378-081332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage16103-378-111332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage16103-378-071332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage16103-378-08fb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage16103-378-11fb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage16103-378-07fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage16103-378-0886f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage16103-378-1186f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage16103-378-0786f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage16103-378-08bd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage16103-378-11bd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage16103-378-07bd6a592717d7…303034d00443…

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-S
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SENNOSIDES8.6 mg/1
DOCUSATE SODIUM50 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
3FYP5M0IJXInternal UNII lookup
F05Q2T2JA0Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
998740Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
2b5152b2-d354-409f-a19f-b470f4181b3fAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
16103-378-072024-12-31Drug Facts
16103-378-082024-12-31Drug Facts
16103-378-112024-12-31Drug Facts
16103-378-072022-01-28Drug Facts
16103-378-082022-01-28Drug Facts
16103-378-112022-01-28Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
16103-378-07Senna-S60 in 1 BOTTLE, PLASTICTABLET, FILM COATED603
16103-378-08Senna-S100 in 1 BOTTLE, PLASTICTABLET, FILM COATED1003
16103-378-11Senna-S1000 in 1 BOTTLE, PLASTICTABLET, FILM COATED10003

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16103-378-11EA - Each16103-378011d0b12-3043-4597-a0fa-fbe72c961b7d12019-03-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16103-378SENNA-S (SENNOSIDES 8.6MG AND DOCUSATE SODIUM 50MG) TABLET, FILM COATED [PHARBEST PHARMACEUTICALS, INC.]2Current NDC, Legacy NDC, 3 package rows20250101_2b5152b2-d354-409f-a19f-b470f4181b3f.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 29 of 42 · 833 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Chocolated LaxativeSENNOSIDES STIMULANT LAXATIVEWalgreensc8ea170b-57b5-4643-ba88-4cf2ae1bf6a02024-12-23WarningsExact identifier
application number: M007
SennosidesSENNOSIDESMeijer, Inc.b09a234e-962d-49fc-a72e-898547b2f0992024-12-23WarningsExact identifier
application number: M007
Pedia-LaxGLYCERINC.B. Fleet Company, Inc.4e15f6ca-a40c-485f-be3f-07c2ed7cb4982024-12-23WarningsExact identifier
application number: M007
Chocolate Laxative Regular strength, Sennosides Stimulant Laxative, equateSENNOSIDESWal-Mart Stores Inc10dc8b4d-8136-44a5-a2ce-30295866cd3b2024-12-23WarningsExact identifier
application number: M007
Chocolated Laxative Regular Strength Sennosides Stimulant Laxative, Best ChoiceSENNOSIDESValu Merchandisers Company4b7cab4b-a610-4fb9-ac31-011975f1b29c2024-12-23WarningsExact identifier
application number: M007
Chocolated Laxative Regular Strength Sennosides Stimulant Laxative, DG healthSENNOSIDESDolgencorp Inc.88dc2f9b-18ca-4e21-8faa-5339f82a2a752024-12-23WarningsExact identifier
application number: M007
Chocolated Laxative Regular Strength Sennosides Stimulant Laxative TopCare healthSENNOSIDESTopco Associatesf051b302-f70e-4ab6-bb69-f69b45f2642e2024-12-23WarningsExact identifier
application number: M007
Chocolated LaxativeSENNOSIDES STIMULANT LAXATIVEC.D.M.A., Inc.e80be2b6-a0ca-4838-b956-a1debb065d572024-12-23WarningsExact identifier
application number: M007
ConlaxBISACODYLBliss GVS Pharma Limited7d25990b-6f7c-1eac-e053-2a91aa0a70222024-12-21WarningsExact identifier
application number: M007
GeriCare Docusate Sodium LiquidDOCUSATE SODIUMGERI-CARE PHARMACEUTICALS, CORPe50558e1-f0c8-4b03-9109-6a273b61730d2024-12-20WarningsExact identifier
application number: M007
SENNA SyrupSENNOSIDES A AND BSDA Laboratories, Inc.cfc6ab2f-5376-46fc-ac58-7dedd70100062024-12-20WarningsExact identifier
application number: M007
Fiber TherapyCALCIUM POLYCARBOPHILWal-Mart Stores, Inc.3432a4a6-aeb1-4a72-8451-5903266931fa2024-12-20WarningsExact identifier
application number: M007
Fiber LaxativeCALCIUM POLYCARBOPHILUNITED NATURAL FOODS, INC. DBA UNFIf7236bbc-8ded-4e11-8cce-b0a2255e14502024-12-20WarningsExact identifier
application number: M007
Fiber CapsCALCIUM POLYCARBOPHILGuardian Drug Company31e6b0c7-1d4a-4660-ae87-9d18e0001dcd2024-12-19WarningsExact identifier
application number: M007
Epsom SaltsMAGNESIUM SULFATENEW PRIDE CORPf6626023-4857-518b-e053-2a95a90a98212024-12-19WarningsExact identifier
application number: M007
MILK OF MAGNESIA CHERRYMAGNESIUM HYDROXIDEWALGREEN COMPANY5fae9b56-2555-b583-e053-2991aa0a8d592024-12-19WarningsExact identifier
application number: M007
MILK OF MAGNESIAMAGNESIUM HYDROXIDEWALGREEN COMPANY5faf2ed0-dd71-17c9-e053-2a91aa0ab75a2024-12-19WarningsExact identifier
application number: M007
Stimulant Laxative Plus Stool SoftenerDOCUSATE SODIUM 50 MG AND SENNOSIDES 8.6 MGRUGBY LABORATORIESf5afd8eb-d35d-44ab-897d-1d41c98ca1382024-12-19WarningsExact identifier
application number: M007
Goodsense FiberMETHYLCELLULOSEGoodSense96ed1ba1-7f91-4912-a549-a4be2c3e03622024-12-19WarningsExact identifier
application number: M007
Senexon-SDOCUSATE SODIUM 50MG AND SENNOSIDES 8.6MGRUGBY LABORATORIES2e758ff1-3083-4245-8f58-1c47b042bfdd2024-12-19WarningsExact identifier
application number: M007

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
998740sennosides 8.6 MG / docusate sodium 50 MG Oral TabletPSN2b5152b2-d354-409f-a19f-b470f4181b3f3
998740docusate sodium 50 MG / sennosides, USP 8.6 MG Oral TabletSCD2b5152b2-d354-409f-a19f-b470f4181b3f3
998740DOSS Sodium 50 MG / sennosides, USP 8.6 MG Oral TabletSY2b5152b2-d354-409f-a19f-b470f4181b3f3
998740sennosides 8.6 MG / docusate sodium 50 MG Oral TabletPSN8678a3ee-0e2c-4c95-ad2e-83aa601f32382
998740docusate sodium 50 MG / sennosides, USP 8.6 MG Oral TabletSCD8678a3ee-0e2c-4c95-ad2e-83aa601f32382
998740DOSS Sodium 50 MG / sennosides, USP 8.6 MG Oral TabletSY8678a3ee-0e2c-4c95-ad2e-83aa601f32382

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
16103-378-071610303780760 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (16103-378-07) 2018-11-050000-00-00NoNoCurrent
16103-378-0816103037808100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (16103-378-08) 2019-02-210000-00-00NoNoCurrent
16103-378-11161030378111000 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (16103-378-11) 2018-11-050000-00-00NoNoCurrent