FDA.reportPublic FDA data

CVS Health Stool Softener Plus stimulant laxative Softgel

Product NDC
51316-318
11-digit product format
513160318
Labeler code
51316
Product ID
51316-318_afe1a0f3-3fd4-419a-bf25-75c7203fa45f
Type
HUMAN OTC DRUG
Nonproprietary name
Docusate sodium, Sennosides
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
CVS Pharmacy, Inc
Application
M007
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-03-19
Substance
DOCUSATE SODIUM; SENNOSIDES
Active strength
50; 8.6 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
CVS Health Stool Softener Plus stimulant laxative Softgel
Listing expiration
2026-12-31

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
1791612Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2881d83d-9929-677a-e063-6394a90a0424Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51316-318-06CVS Health Stool Softener Plus stimulant laxative Softgel1 in 1 CARTONCAPSULE, LIQUID FILLED12
51316-318-06CVS Health Stool Softener Plus stimulant laxative Softgel60 in 1 BOTTLECAPSULE, LIQUID FILLED602

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51316-318CVS HEALTH STOOL SOFTENER PLUS STIMULANT LAXATIVE SOFTGEL (DOCUSATE SODIUM, SENNOSIDES) CAPSULE, LIQUID FILLED [CVS PHARMACY, INC]2Current NDC, 2 package rows20250327_2881d83d-9929-677a-e063-6394a90a0424.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
1791612sennosides 8.6 MG / docusate sodium 50 MG Oral CapsulePSN2881d83d-9929-677a-e063-6394a90a04242
1791612docusate sodium 50 MG / sennosides, USP 8.6 MG Oral CapsuleSCD2881d83d-9929-677a-e063-6394a90a04242
1791612DOSS Sodium 50 MG / sennosides, USP 8.6 MG Oral CapsuleSY2881d83d-9929-677a-e063-6394a90a04242

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
51316-318-06513160318061 BOTTLE in 1 CARTON (51316-318-06) / 60 CAPSULE, LIQUID FILLED in 1 BOTTLE1 bottle2025-03-19NoNoCurrent