FDA.reportPublic FDA data

Senna Tabs

Product NDC
16103-363
Requested package NDC
16103-363-08
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 · 9 matching rows.

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

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

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#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SENNOSIDES A AND BACTIVE INGREDIENT1B5FPI42ENSENNA TABS (SENNA) TABLET, FILM COATED [PHARBEST PHARMACEUTICALS, INC.]1
SENNOSIDES A AND BACTIVE MOIETY1B5FPI42ENSENNA TABS (SENNA) TABLET, FILM COATED [PHARBEST PHARMACEUTICALS, INC.]1
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSINACTIVE INGREDIENTL11K75P92JSENNA TABS (SENNA) TABLET, FILM COATED [PHARBEST PHARMACEUTICALS, INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61USENNA TABS (SENNA) TABLET, FILM COATED [PHARBEST PHARMACEUTICALS, INC.]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48SENNA TABS (SENNA) TABLET, FILM COATED [PHARBEST PHARMACEUTICALS, INC.]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOSENNA TABS (SENNA) TABLET, FILM COATED [PHARBEST PHARMACEUTICALS, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30SENNA TABS (SENNA) TABLET, FILM COATED [PHARBEST PHARMACEUTICALS, INC.]1
MINERAL OILINACTIVE INGREDIENTT5L8T28FGPSENNA TABS (SENNA) TABLET, FILM COATED [PHARBEST PHARMACEUTICALS, INC.]1

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 1 of 44 · 873 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CVS Health Childrens Saline LaxativeMAGNESIUM HYDROXIDECVS PHARMACY,INC.e57e5529-2190-4c66-8397-bc2848739e592026-08-14WarningsExact identifier
application number: M007
Docusate Sodium and SennosidesDOCUSATE SODIUM AND SENNOSIDESMorepen Bio Inc562d1b9a-09d8-92fc-e063-6394a90a19932026-08-14WarningsExact identifier
application number: M007
CVS HealthNATURAL FIBER SUPPLEMENTCVS Pharmacy,Inc.04dbe9aa-ed18-4d76-a840-d010445a86432026-08-14WarningsExact identifier
application number: M007
CVS Fiber TherapyMETHYLCELLULOSECVS PHARMACYe066f5bd-5f34-4e04-beec-3c7d6db493812026-08-13WarningsExact identifier
application number: M007
Mineral oilMINERAL OILEQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)92f2147d-b52d-4282-b217-28f6095dca0e2026-08-12WarningsExact identifier
application number: M007
CAREONE Orange FlavoredPSYLLIUM HUSKFOODHOLD USA4b1cccd2-e941-4d51-9924-4ca35e3a44292026-08-11WarningsExact identifier
application number: M007
CAREONEPSYLLIUM HUSKFOODHOLD USA3ec3ead0-382e-4765-bbe8-b21e7c7b42a62026-08-11WarningsExact identifier
application number: M007
Stool SoftenerDOCUSATE SODIUMDolgencorp, Inc. (DOLLAR GENERAL & REXALL)f4671579-aed0-4f93-ab83-248e0d72b5b02026-08-10WarningsExact identifier
application number: M007
Docusate Sodium LiquidDOCUSATE SODIUM.50MG/5MLAldama Pharmaceuticals, Inc492b6d37-47cf-3a28-e063-6294a90a2a182026-08-10WarningsExact identifier
application number: M007
Epsom SaltMAGNESIUM SULFATESafeway Inc0b757160-f9eb-4413-9b43-97544c49c72f2026-08-10Warnings, Adverse reactionsExact identifier
application number: M007
Senna SDOCUSATE SODIUM, SENNOSIDESShield Pharmaceuticals Corp0be906d8-3db5-4218-bbdf-f1d1260079902026-08-07WarningsExact identifier
application number: M007
MiraFAST KIDS soft chewsMAGNESIUM HYDROXIDEBayer HealthCare LLC.58636827-239d-cc63-e063-6294a90a61802026-08-06WarningsExact identifier
application number: M007
Stool Softener Extra StrengthDOCUSATE SODIUMP & L Development, LLC4e97dd60-96e3-4b51-b614-c62480af19192026-08-06WarningsExact identifier
application number: M007
Stool Softener LaxativeDOCUSATE SODIUMP & L Development, LLC098d2377-0019-45fe-b995-700b1b1241c42026-08-05WarningsExact identifier
application number: M007
Docusate Sodium softgels 50mg (Dye Free)DOCUSATE SODIUMCVS Pharmacy273ea95f-3c9c-98e8-e063-6294a90a21352026-08-05WarningsExact identifier
application number: M007
Mineral OilMINERAL OILOld East Main Co.4bae831d-caba-40c9-bdb5-2611eac35dd52026-08-05Warnings, Adverse reactionsExact identifier
application number: M007
Metamucil Therapy for regularityPSYLLIUM HUSKAtlantic Biologicals Corp.57b112ea-f6b1-baa6-e063-6394a90a3b292026-08-05WarningsExact identifier
application number: M007
MiraFAST soft chewsMAGNESIUM HYDROXIDEBayer HealthCare LLC.2cee67dd-b71f-32b8-e063-6394a90ae8642026-08-05WarningsExact identifier
application number: M007
MiraSOFT Stool SoftenerDOCUSATE SODIUMBayer HealthCare LLC.5851f15f-8add-559f-e063-6394a90a7b7d2026-08-05WarningsExact identifier
application number: M007
Stool Softener LaxativeDOCUSATE SODIUMP & L Development, LLCcbb0edf4-1fa7-42f5-a6f7-027e3961b50a2026-08-05WarningsExact 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