FDA.reportPublic FDA data

Stool Softener

Product NDC
21130-902
11-digit product format
211300902
Labeler code
21130
Product ID
21130-902_255d1ce7-fe7d-8c00-e063-6394a90a7b4b
Type
HUMAN OTC DRUG
Nonproprietary name
Docusate sodium and Sennosides
Dosage form
TABLET
Route
ORAL
Labeler
BETTER LIVING BRANDS LLC.
Application
M007
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-09-30
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

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
Stool Softener
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
f2c61c71-9a23-4bd3-e053-2a95a90ad460Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21130-902-20Stool Softener200 in 1 BOTTLETABLET2002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21130-902STOOL SOFTENER (DOCUSATE SODIUM AND SENNOSIDES) TABLET [BETTER LIVING BRANDS LLC.]2Current NDC, 1 package rows20250110_f2c61c71-9a23-4bd3-e053-2a95a90ad460.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 · 833 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MILK OF MAGNESIAMAGNESIUM HYDROXIDEWal-Mart Stores, Inc.750e0355-369e-b679-e053-2a91aa0a66ca2023-11-01WarningsExact identifier
application number: M007
MILK OF MAGNESIAMAGNESIUM HYDROXIDEWal-Mart Stores, Inc.750efd58-5845-fbc4-e053-2a91aa0a86d12023-11-01WarningsExact identifier
application number: M007
Gentle LaxativeMAGNESIUM HYDROXIDEWALGREEN COMPANYba4a29b3-2ddc-b906-e053-2995a90a2ab72023-11-01WarningsExact identifier
application number: M007
DOCUZENSENNOSIDES 8.6MG AND DOCUSATE SODIUM 50MGProficient Rx LP92879e62-f60a-4ab4-9532-610cdd2628ee2023-11-01WarningsExact identifier
application number: M007
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
998740sennosides 8.6 MG / docusate sodium 50 MG Oral TabletPSNf2c61c71-9a23-4bd3-e053-2a95a90ad4602
998740docusate sodium 50 MG / sennosides, USP 8.6 MG Oral TabletSCDf2c61c71-9a23-4bd3-e053-2a95a90ad4602
998740DOSS Sodium 50 MG / sennosides, USP 8.6 MG Oral TabletSYf2c61c71-9a23-4bd3-e053-2a95a90ad4602

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
21130-902-2021130090220200 TABLET in 1 BOTTLE (21130-902-20) 200 tablet2024-09-30NoNoCurrent