FDA.reportPublic FDA data

Stool Softener

Product NDC
41163-778
11-digit product format
411630778
Labeler code
41163
Product ID
41163-778_b0672540-0f64-4d5d-ade2-16a05d40ba75
Type
HUMAN OTC DRUG
Nonproprietary name
docusate sodium and sennosides
Dosage form
TABLET
Route
ORAL
Labeler
United Natural Foods, Inc. dba UNFI
Application
M007
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-06-25
Substance
DOCUSATE SODIUM; SENNOSIDES
Active strength
50; 8.6 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
Stool Softener
Brand name suffix
Plus Stimulant
Listing expiration
2027-12-31

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
6c8c7c46-3ded-4e89-8e16-30eeb72aa08bAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
41163-778-10Stool SoftenerPlus Stimulant100 in 1 BOTTLE, PLASTICTABLET1003

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41163-778STOOL SOFTENER PLUS STIMULANT (DOCUSATE SODIUM AND SENNOSIDES) TABLET [UNITED NATURAL FOODS, INC. DBA UNFI]3Current NDC, Legacy NDC, 1 package rows20240616_6c8c7c46-3ded-4e89-8e16-30eeb72aa08b.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 20 of 42 · 833 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
up and up fiber therapyPSYLLIUM HUSKTarget Corporation674753ee-1174-4c06-9ed3-a090b338a39e2025-11-05WarningsExact identifier
application number: M007
up and up fiber therapyPSYLLIUM HUSKTARGET CORPORATION956c48f8-c705-4a86-9866-c68a48ddeb6c2025-11-05WarningsExact identifier
application number: M007
CEO-TWOLAXATIVEBeutlich Pharmaceuticals, LLC08670636-5795-4db0-e063-6294a90afa4b2025-11-05WarningsExact identifier
application number: M007
up and up gentle laxativeBISACODYLTarget Corporation4a29dc2b-b68f-471b-a84e-4a5096aa37482025-11-04WarningsExact identifier
application number: M007
Target Fiber LaxativePSYLLIUM HUSKTARGET CORPORATIONa581116a-392d-4ac3-ae15-4318506a7b2a2025-11-04WarningsExact identifier
application number: M007
up and up fiber therapyCALCIUM POLYCARBOPHILTarget Corporation.e5473950-06f4-4ea4-975b-3ac94957e7762025-11-04WarningsExact identifier
application number: M007
up and up fiber therapy Natural FiberPSYLLIUM HUSKTarget Corporationf8b1c831-6fd0-4a58-9726-4e0f986c80842025-11-04WarningsExact identifier
application number: M007
OneLAXBISACODYLAKRON PHARMA INCbe4eeb4d-df29-45dc-94ff-933e52c8b6f62025-11-03WarningsExact identifier
application number: M007
Gentle Stool SoftenerDOCUSATE SODIUMWALGREEN COMPANY169b33f9-e559-47bf-bbba-c7eda4762c7f2025-10-31WarningsExact identifier
application number: M007
Senna SDOCUSATE SODIUM, SENNOSIDESWalgreens765bfd9b-7a21-4315-9add-cf13007722d52025-10-31WarningsExact identifier
application number: M007
Gentle Stool SoftenerDOCUSATE SODIUMWALGREEN COMPANY71b15339-2585-4fae-8445-6fbb4f0a378e2025-10-31WarningsExact identifier
application number: M007
Stool Softener LaxativeDOCUSATE SODIUMMajor Pharmaceuticals97561cd4-63d9-44c2-a3a3-ec668a09a4ed2025-10-31WarningsExact identifier
application number: M007
Fiber CapletsCALCIUM POLYCARBOPHILSAFEWAY08e2e8b0-90b3-48d6-a72a-40688c74771a2025-10-29WarningsExact identifier
application number: M007
GlycerinGLYCERINChain Drug Marketing Association Inc.424d91f0-ecf9-6d9b-e063-6394a90a80062025-10-29WarningsExact identifier
application number: M007
Publix Laxative Maximum StrengthCALCIUM SENNOSIDESPUBLIX SUPER MARKETS, INC11112859-ef1e-4b37-9915-ba4d06a3f1982025-10-28WarningsExact identifier
application number: M007
Publix Stimulant LaxativeBISACODYLPUBLIX SUPER MARKETS, INC02e596a7-b8e5-4f55-9bc6-6d17e0fabda72025-10-28WarningsExact identifier
application number: M007
PUBLIXPSYLLIUM HUSKPUBLIX SUPER MARKETS, INC55f98d3f-f282-4f19-b373-0b59640d274d2025-10-28WarningsExact identifier
application number: M007
PUBLIXCALCIUM POLYCARBOPHILPUBLIX SUPER MARKETS, INC02e3f4ce-8961-425c-98a9-3b9d66709ca52025-10-28WarningsExact identifier
application number: M007
Publix Women LaxativeBISACODYLPUBLIX SUPER MARKETS, INC03eeca55-f239-4a01-a900-c1943f27a8342025-10-28WarningsExact identifier
application number: M007
Publix Fiber Therapy Orange SmoothPSYLLIUM HUSKPUBLIX SUPER MARKETS, INCb9c54c20-cd82-4627-9217-a66834db47992025-10-28WarningsExact identifier
application number: M007

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
998740sennosides 8.6 MG / docusate sodium 50 MG Oral TabletPSN6c8c7c46-3ded-4e89-8e16-30eeb72aa08b3
998740docusate sodium 50 MG / sennosides, USP 8.6 MG Oral TabletSCD6c8c7c46-3ded-4e89-8e16-30eeb72aa08b3
998740DOSS Sodium 50 MG / sennosides, USP 8.6 MG Oral TabletSY6c8c7c46-3ded-4e89-8e16-30eeb72aa08b3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
41163-778-1041163077810100 TABLET in 1 BOTTLE, PLASTIC (41163-778-10) 100 tablet2021-06-250000-00-00NoNoCurrent