FDA.reportPublic FDA data

Senna S

Product NDC
53329-989
11-digit product format
533290989
Labeler code
53329
Product ID
53329-989_536f49ab-7030-6114-e063-6394a90ad18e
Type
HUMAN OTC DRUG
Nonproprietary name
sennosides and docusate sodium
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Medline Industries, LP
Application
M007
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2018-05-22
Marketing end
2028-05-31
Substance
DOCUSATE SODIUM; SENNOSIDES
Active strength
50; 8.6 mg/1; mg/1
NDC exclude flag
No
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

Active Ingredients#

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

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
F05Q2T2JA0Internal UNII lookup
3FYP5M0IJXInternal 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
6cd22881-db60-9045-e053-2991aa0ae08aAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53329-989-62Senna S60 in 1 BOTTLE, PLASTICTABLET, COATED608

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53329-989SENNA S (SENNOSIDES AND DOCUSATE SODIUM) TABLET, COATED [MEDLINE INDUSTRIES, LP]8Current NDC, Legacy NDC, 1 package rows20241127_6cd22881-db60-9045-e053-2991aa0ae08a.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 35 of 42 · 833 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Stool SoftenerDOCUSATE SODIUMBryant Ranch Prepack2c9a1fe7-b77b-436b-8701-9f95f642d0012024-07-05WarningsExact identifier
application number: M007
SENNASENNAPrecision Dose, Inc.e637777e-a39d-4e2f-a95c-4f524aa122f72024-07-05WarningsExact identifier
application number: M007
Gentle LaxativeMAGNESIUM HYDROXIDEGERI-CARE PHARMACEUTICALS, CORP1c462af8-af1a-391c-e063-6394a90a8b492024-07-02WarningsExact identifier
application number: M007
Good Neighbor Pharmacy Fiber-Caps Fiber Laxative Stimulant FreeCALCIUM POLYCARBOPHILAmerisourcebergen Drug Corporation4911fb44-e070-46c1-8f90-b78ceb10e51e2024-06-28WarningsExact identifier
application number: M007
FleetDOCUSATE SODIUMC.B. Fleet Company, Inc.56a7b6c5-d674-4eed-91c2-77f7d18fff322024-06-27WarningsExact identifier
application number: M007
Stool Softener Laxative Extra StrengthDOCUSATE SODIUMWALMART INC. (see also Equate)2cf6c9bf-c318-445d-9306-5675b1d424b02024-06-26WarningsExact identifier
application number: M007
Stool Softener LaxativeDOCUSATE SODIUMWALMART INC. (see also Equate)d9db24b5-e3b5-47f9-b86b-bc8d70896a112024-06-26WarningsExact identifier
application number: M007
Stool SoftenerDOCUSATE CALCIUMWalgreens2791223a-7ac0-47e5-9a6a-4d9a02cfeb632024-06-25WarningsExact identifier
application number: M007
FleetBISACODYLC.B. Fleet Company, Inc.4e0d973f-e6dc-48d9-8df3-1d47c87840f12024-06-21WarningsExact identifier
application number: M007
Stool Softener Plus Stimulant LaxativeDOCUSATE SODIUM AND SENNOSIDESTOP CARE (Topco Associates LLC)3b184800-649b-45d0-9586-8055d6d7fe082024-06-20WarningsExact identifier
application number: M007
Senna LaxativeSENNA LAXATIVEGood Sense9393032e-4343-4ac5-8e91-36013e5ca0892024-06-18WarningsExact identifier
application number: M007
Stool SoftenerSTOOL SOFTENERGood Sense64266195-1b07-42c2-98a7-d76c12f747762024-06-18WarningsExact identifier
application number: M007
Stool Softener Plus StimulantDOCUSATE SODIUM AND SENNOSIDESUnited Natural Foods, Inc. dba UNFI6c8c7c46-3ded-4e89-8e16-30eeb72aa08b2024-06-14WarningsExact identifier
application number: M007
Stool Softener Plus Stimulant LaxativeDOCUSATE SODIUM AND SENNOSIDESUnited Natural Foods, Inc. dba UNFI50ca1ce2-885f-4b71-a5fb-90c2cf508ce62024-06-14WarningsExact identifier
application number: M007
basic care stool softenerDOCUSATE SODIUMAmazon.com Services LLC356a889f-ec23-4eb2-a25c-bbe6094751552024-06-14WarningsExact identifier
application number: M007
Stool Softener LaxativeDOCUSATE SODIUMUnited Natural Foods, Inc. dba UNFI88cc2575-27a1-4514-bc41-bd1eac2838142024-06-13WarningsExact identifier
application number: M007
Senna laxativeSENNOSIDESUnited Natural Foods, Inc. dba UNFI2b5e1f03-0182-4d1c-8ba0-b1008b1335ad2024-06-12WarningsExact identifier
application number: M007
Stool Softener LaxativeDOCUSATE SODIUMTARGET Corporation1b7edd67-7b14-4fdd-9821-637f4b3c3a2c2024-06-06WarningsExact identifier
application number: M007
SennaSENNOSIDESPatrin Pharma, Inc.a9f1ef8d-8700-481f-a709-972bb9d271532024-05-30WarningsExact identifier
application number: M007
MILK OF MAGNESIAMAGNESIUM HYDROXIDEWALGREEN COMPANY5f9cd233-6c46-5b52-e053-2991aa0ab7292024-05-23WarningsExact identifier
application number: M007

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
998740sennosides 8.6 MG / docusate sodium 50 MG Oral TabletPSN6cd22881-db60-9045-e053-2991aa0ae08a8
998740docusate sodium 50 MG / sennosides, USP 8.6 MG Oral TabletSCD6cd22881-db60-9045-e053-2991aa0ae08a8
998740DOSS Sodium 50 MG / sennosides, USP 8.6 MG Oral TabletSY6cd22881-db60-9045-e053-2991aa0ae08a8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
53329-989-625332909896260 TABLET, COATED in 1 BOTTLE, PLASTIC (53329-989-62) 2018-05-222028-05-31NoNoCurrent