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 36 of 42 · 833 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Stool Softener LaxativeDOCUSATE SODIUMUnited Natural Foods, Inc. dba UNFIb1d903a5-1d5f-44d4-9939-a4b86e5a620d2024-05-23WarningsExact identifier
application number: M007
Senna laxativeSENNOSIDESUnited Natural Foods, Inc. dba UNFI30b9bbf3-0a64-41de-bfb4-5c8c257cc3e82024-05-23WarningsExact identifier
application number: M007
Gentle LaxativeMAGNESIUM HYDROXIDEMEIJER, INC.11fe5bd0-585a-ad8a-e063-6294a90a3ae82024-05-22WarningsExact identifier
application number: M007
Stool SoftenerDOCUSATE SODIUMSam's West, Incb14d2495-1092-4063-869f-73a7e8c287082024-05-21WarningsExact identifier
application number: M007
Stool Softener Plus Stimulant LaxativeDOCUSATE SODIUM AND SENNOSIDESSafeway, Inc.6bc9ea37-31b8-4a6d-9b2d-2c80bad4f30d2024-05-15WarningsExact identifier
application number: M007
Stool Softener Plus Stimulant LaxativeDOCUSATE SODIUM AND SENNOSIDESSafeway, Inc.c0898583-4bbb-41d5-9e84-00cca823024f2024-05-15WarningsExact identifier
application number: M007
Senna SDOCUSATE SODIUM SENNOSIDESQUALITY CHOICE (Chain Drug Marketing Association)9c986ca8-d540-49c1-b092-94c1bf837c072024-05-09WarningsExact identifier
application number: M007
FleetGLYCERINC.B. Fleet Company, Inc.381f4179-0c3b-41f8-927c-c88534ebe06d2024-05-06WarningsExact identifier
application number: M007
Docusate SodiumDOCUSATE SODIUMNuCare Pharmaceuticals,Inc.ed20d198-e935-200e-e053-2a95a90a309b2024-05-02WarningsExact identifier
application number: M007
Sennosides, Docusate SodiumSENNOSIDES, DOCUSATE SODIUMMajor Pharmaceuticals1768b470-2808-fa46-e063-6394a90ac8d92024-05-01WarningsExact identifier
application number: M007
Stool Softener Stimulant laxativeDOCUSATE SODIUM AND SENNOSIDESQUALITY CHOICE (Chain Drug Marketing Association)9467e1f7-19bb-4fb3-853b-75c4d28bb9a92024-05-01WarningsExact identifier
application number: M007
Stool Softener LaxativeDOCUSATE SODIUM AND SENNOSIDESQUALITY CHOICE (Chain Drug Marketing Association)72f8e8d7-ee38-4bd3-8711-f11fded0cede2024-05-01WarningsExact identifier
application number: M007
Stool Softener Laxative Extra StrengthDOCUSATE SODIUMP & L Development, LLCc1e9863a-c229-4694-b450-6b0e0ad375032024-04-30WarningsExact identifier
application number: M007
Stool Softener LaxativeDOCUSATE SODIUMQUALITY CHOICE (Chain Drug Marketing Association)96c7f8bc-be95-40d1-9977-44b7cc6582df2024-04-22WarningsExact identifier
application number: M007
Pedia-LaxMAGNESIUM HYDROXIDEC.B. Fleet Company, Inc.975f24d8-218c-40f4-84a5-558acf34329d2024-04-11WarningsExact identifier
application number: M007
Stool Softener LaxativeDOCUSATE SODIUM AND SENNOSIDESH E B2f9e2723-53a7-47a8-8c41-87bffc4e50dd2024-04-09WarningsExact identifier
application number: M007
SennaSENNOSIDESH E Bd047e4e9-b8ac-498e-9fde-8af5d415edaa2024-04-09WarningsExact identifier
application number: M007
Stool Softener LaxativeDOCUSATE SODIUMH E B5b8bcc6c-de03-4d73-a76f-6f4c371cf2502024-04-09WarningsExact identifier
application number: M007
Stool SoftenerDOCUSATE SODIUMH E B1dd2be7e-bdca-4e43-b853-3ed10b6366322024-04-08WarningsExact identifier
application number: M007
Stool SoftenerDOCUSATE SODIUMBryant Ranch Prepack1f11cf85-b094-4ca4-8b48-2d3a9093304b2024-04-04WarningsExact 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