FDA.reportPublic FDA data

Senna-S

Product NDC
71205-970
Requested package NDC
71205-970-60
11-digit product format
712050970
Labeler code
71205
Product ID
71205-970_4fa397fd-b64f-4219-962e-8d3ba9261778
Type
HUMAN OTC DRUG
Nonproprietary name
Sennosides 8.6mg and Docusate Sodium 50mg
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Proficient Rx LP
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
2027-12-31
Current FDA listing
Yes

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
2027-12-31

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
8678a3ee-0e2c-4c95-ad2e-83aa601f3238Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71205-970-00Senna-S100 in 1 BOTTLE, PLASTICTABLET, FILM COATED1002
71205-970-11Senna-S1000 in 1 BOTTLE, PLASTICTABLET, FILM COATED10002
71205-970-30Senna-S30 in 1 BOTTLE, PLASTICTABLET, FILM COATED302
71205-970-55Senna-S500 in 1 BOTTLE, PLASTICTABLET, FILM COATED5002
71205-970-60Senna-S60 in 1 BOTTLE, PLASTICTABLET, FILM COATED602
71205-970-90Senna-S90 in 1 BOTTLE, PLASTICTABLET, FILM COATED902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71205-970-00EA - Each71205-97074e69d17-bf29-44a9-89b6-9f89a7d2381112021-10-08
71205-970-11EA - Each71205-970061eed84-e4f4-410d-8eae-887958d83f1112021-10-08
71205-970-30EA - Each71205-970979f29e4-bbf2-442a-9303-f2cff5bbc96a12021-10-08
71205-970-55EA - Each71205-97092be220d-95b3-44bf-979b-9e5b26d7f7de12021-10-08
71205-970-60EA - Each71205-9708dfa4212-4ad6-486b-854e-5c7987c1dcd912021-10-08
71205-970-90EA - Each71205-9705f48dda3-04b3-4bfc-b24f-bc1f726ebcde12021-10-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-970SENNA-S (SENNOSIDES 8.6MG AND DOCUSATE SODIUM 50MG) TABLET, FILM COATED [PROFICIENT RX LP]2Current NDC, Legacy NDC, 6 package rows20241027_8678a3ee-0e2c-4c95-ad2e-83aa601f3238.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 43 · 858 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SENOKOTSTANDARDIZED SENNAA-S Medication Solutions0c6e6bdd-9f49-4550-b60a-8f58b7c0f0902026-09-09WarningsExact identifier
application number: M007
BisacodylBISACODYLKROGER COMPANYa13a8eec-3652-8c57-e053-2995a90aaebf2026-09-09WarningsExact identifier
application number: M007
Stool Softener LaxativeDOCUSATE SODIUMTARGET Corporation4180a35b-cc50-46ae-a100-99bb218c10ff2026-09-09WarningsExact identifier
application number: M007
fiber laxativePSYLLIUM HUSKRaritan Pharmaceuticals Inc22e927bd-5734-424e-8870-1aaa18f1265e2026-09-08WarningsExact identifier
application number: M007
DRx Choice Fiber TherapyMETHYLCELLULOSERARITAN PHARMACEUTICALS INC5e5749f7-074e-4bbc-9f33-5090e603fdb42026-09-08WarningsExact identifier
application number: M007
Bisacodyl Stimulant LaxativeBISACODYLRaritan Pharmaceuticals Incb99c1a6d-3034-4822-8540-210179c068572026-09-08WarningsExact identifier
application number: M007
Daily Fiber Sugar FreePSYLLIUM HUSKRaritan Pharmaceuticals Inc9c4c41d8-a2d5-4168-9e97-9f9d47fc5e632026-09-08WarningsExact identifier
application number: M007
DRx Choice Fiber TherapyMETHYLCELLULOSERARITAN PHARMACEUTICALS INC56c7f197-f01a-4611-a761-cda18da6eed02026-09-08WarningsExact identifier
application number: M007
Sennosides 8.6 mgSENNOSIDESMorepen Bio Inc562c9f11-0ba1-011d-e063-6394a90a604a2026-09-05WarningsExact identifier
application number: M007
Epsom SaltMAGNESIUM SULFATETarget Corporation87f98e6c-a3a1-4ca5-bd56-977e38f489142026-09-04Warnings, Adverse reactionsExact identifier
application number: M007
Kroger Stool Softener Fruit PunchDOCUSATE SODIUMKROGER COMPANYb86f8f3d-594e-466c-854a-b8bff9f7a0b82026-09-02WarningsExact identifier
application number: M007
OilMINERAL OILAtlantic Biologicals Corp.5a82197b-281d-76c0-e063-6294a90a57462026-09-02Warnings, Adverse reactionsExact identifier
application number: M007
Kroger Senna Laxative Regular StrengthSENNOSIDESKROGER COMPANYdbb040bb-21f9-43e8-9705-689aeee4d04c2026-09-01WarningsExact identifier
application number: M007
OneLAX SENNASENNAAkron Pharma Inc.27fa8f54-ed84-4afd-8da3-8754da48643b2026-09-01WarningsExact identifier
application number: M007
OneLAX Saline LaxativeMAGNESIUM CITRATEAKRON PHARMA INC44c87bbc-2507-4b87-a74b-02f4acb30cf42026-09-01WarningsExact identifier
application number: M007
OneLAX Saline LaxativeMAGNESIUM CITRATEAKRON PHARMA INCe6de00e6-dd81-4aab-af23-04fab261c6ff2026-09-01WarningsExact identifier
application number: M007
EZ2Go Magnesium Citrate Saline Laxative Lemon FlavorMAGNESIUM CITRATEValley Medical Products LLC5a71e88c-d8cc-a8bb-e063-6294a90af4f72026-09-01WarningsExact identifier
application number: M007
Fiber CapletsCALCIUM POLYCARBOPHILTHE KROGER CO.d6856f59-ccc3-40fc-9bf1-7a5394ed12da2026-09-01WarningsExact identifier
application number: M007
Mineral OilMINERAL OILYour Military Exchanges6025dce6-02e8-418c-a248-0b5c33ff60672026-08-28Warnings, Adverse reactionsExact identifier
application number: M007
Magnesium CitrateMAGNESIUM CITRATEChain Drug Marketing Association583b64e7-e48d-6ba6-e063-6294a90ad4d72026-08-28Warnings, Adverse reactionsExact identifier
application number: M007

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
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
71205-970-607120509706060 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71205-970-60) 2020-06-010000-00-00NoNoCurrent