FDA.reportPublic FDA data

Senna-S

Product NDC
71205-970
Requested package NDC
71205-970-90
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 41 of 42 · 829 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Docusate SodiumDOCUSATE SODIUMA-S Medication Solutions5999904a-6ac8-4d9e-951c-6e64e8cd93eb2023-11-01WarningsExact identifier
application number: M007
MILK OF MAGNESIAMAGNESIUM HYDROXIDEVALU MERCHANDISERS COMPANY5e98f9d9-679c-63a2-e053-2991aa0a4b8d2023-10-31WarningsExact identifier
application number: M007
MILK OF MAGNESIAMAGNESIUM HYDROXIDEVALU MERCHANDISERS COMPANY5e957b01-4f44-0a2a-e053-2991aa0a37a02023-10-31WarningsExact identifier
application number: M007
MILK OF MAGNESIAMAGNESIUM HYDROXIDEVALU MERCHANDISERS COMPANY5e993b13-8dc8-6653-e053-2a91aa0a4c2a2023-10-31WarningsExact identifier
application number: M007
MILK OF MAGNESIAMAGNESIUM HYDROXIDECVS3c8e4144-6702-2678-e054-00144ff88e882023-10-31WarningsExact identifier
application number: M007
Fiber LaxativeCALCIUM POLYCARBOPHILMagno-Humphries, Inc.9d22c208-d089-8b6a-e053-2995a90ab90a2023-10-27WarningsExact identifier
application number: M007
Stool Softener Docusate SodiumDOCUSATE SODIUMMagno-Humphries, Inc.a0e6ab9b-fd31-45fd-93d5-b51d705c180a2023-10-27WarningsExact identifier
application number: M007
Sennosides Natural LaxativeSENNOSIDESMagno-Humphries, Inc.9d22bedb-9fca-8421-e053-2a95a90acf4a2023-10-27WarningsExact identifier
application number: M007
Stool Softener Docusate SodiumDOCUSATE SODIUMMagno-Humphries, Inc.9d22d642-8aed-d17e-e053-2995a90ae1822023-10-27WarningsExact identifier
application number: M007
Senna SDOCUSATE SODIUM, SENNOSIDESMagno-Humphries, Inc.9deaf264-6af0-40ba-e053-2a95a90ada0e2023-10-27WarningsExact identifier
application number: M007
FLEETMINERAL OILC.B. Fleet Company, Inc.2528cb5e-437e-41f0-9c34-e9ce57404d8b2023-10-26WarningsExact identifier
application number: M007
Magnesium CitrateMAJOR MAGNESIUM CITRATE ORAL SOLUTION - LEMONMajor Pharmaceuticals088e5543-c947-af78-e063-6294a90a8bc42023-10-25WarningsExact identifier
application number: M007
DOKDOCUSATE SODIUMMAJOR PHARMACEUTICALS7a92070d-98cc-662f-e053-2991aa0aa1b22023-10-23WarningsExact identifier
application number: M007
Stool SoftenerDOCUSATE SODIUMKROGER COMPANYa1afaa71-7e8c-5a49-e053-2a95a90a4db02023-10-23WarningsExact identifier
application number: M007
Stool SoftenerDOCUSATE SODIUMGeri-Care Pharmaceutical Corp644d81ec-d38f-4172-a087-727b94e2fefe2023-10-19WarningsExact identifier
application number: M007
Docusate SodiumDOCUSATE SODIUMAsclemed USA, Inc.30fc8c07-c26b-4bcc-a727-6e193f5727fd2023-10-16WarningsExact identifier
application number: M007
Stool Softener Extra StrengthDOCUSATE SODIUMMEIJER, INC.e43bd2ed-17c7-4530-af72-81a7ad70069c2023-10-12WarningsExact identifier
application number: M007
Stool Softener Plus Stimulant LaxativeDOCUSATE SODIUM AND SENNOSIDESCare One (Retail Business Services, LLC.)9adaec97-43e3-48f2-96c8-c508b693676c2023-10-05WarningsExact identifier
application number: M007
Senna LaxSENNOSIDES 8.6MGTopCo Associates, LLC83aeb90a-ab00-4e26-aa44-5259dce590182021-04-28WarningsExact identifier
application number: M007
Stool SoftenerDOCUSATE SODIUMAllegiant Health9fbe783e-ddd9-445a-852a-00f4ad7548802021-04-20WarningsExact 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
71205-970-907120509709090 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71205-970-90) 2020-06-010000-00-00NoNoCurrent