FDA.reportPublic FDA data

Dual Action Senna Stool Softener

Product NDC
83059-0091
11-digit product format
830590091
Labeler code
83059
Product ID
83059-0091_582a4c49-0c66-7b06-e063-6294a90a67f3
Type
HUMAN OTC DRUG
Nonproprietary name
Docusate sodium 50 mg, Sennosides 8.6 mg
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
Shield Pharmaceuticals Corp
Application
M007
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2026-08-03
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
Dual Action Senna Stool Softener
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
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
a04435df-aace-497f-a3a8-d8e8489db661Available on FDA.report

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 10 of 42 · 833 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Mineral OilMINERAL OILBetter Living Brands, LLC7f2f1b30-497a-4c53-accc-8455169b17b32026-02-24Warnings, Adverse reactionsExact identifier
application number: M007
citromaMAGNESIUM CITRATEFamily Dollar Stores, Inccc97cfb5-cd40-4589-942a-5bee611a28122026-02-24Warnings, Adverse reactionsExact identifier
application number: M007
citromaMAGNESIUM CITRATEFamily Dollar Stores, Inc0ac1896d-7ed9-44e5-bf07-1478262372732026-02-24Warnings, Adverse reactionsExact identifier
application number: M007
Castor OilCASTOR OILChain Drug Marketing Association4a003bb1-425d-cd97-e063-6294a90a5dda2026-02-23Warnings, Adverse reactionsExact identifier
application number: M007
citromaMAGNESIUM CITRATEBetter Living Brands, LLCd8176ef6-cc68-4185-b5eb-e887562f6aaa2026-02-23Warnings, Adverse reactionsExact identifier
application number: M007
citromaMAGNESIUM CITRATEBetter Living Brands, LLC07732845-c9ce-47bb-8b63-36a3d5ddf8b72026-02-23Warnings, Adverse reactionsExact identifier
application number: M007
stimulant laxativeBISACODYLBIONPHARMA INC.4b1f7db3-c6a8-7f6a-e063-6394a90a58292026-02-22WarningsExact identifier
application number: M007
Castor OilCASTOR OILNice-Pak Products, LLCff6c8022-9522-4eae-b8ff-994ee37fba062026-02-19Warnings, Adverse reactionsExact identifier
application number: M007
Castor OilCASTOR OILPerrigo Direct, Inc09e32476-1c60-4f1e-a51c-5fab2e744b302026-02-19Warnings, Adverse reactionsExact identifier
application number: M007
citromaMAGESIUM CITRATEPerrigo Direct, Inc22991685-8228-41e1-a13e-f57961e8dd0e2026-02-19Warnings, Adverse reactionsExact identifier
application number: M007
citromaMAGESIUM CITRATEPerrigo Direct, Inc24478279-9a11-4e12-956d-57dc7debf9412026-02-19Warnings, Adverse reactionsExact identifier
application number: M007
Mineral OilMINERAL OILPerrigo Direct, Incf1656280-fad9-4922-9d5c-be774a8b14222026-02-19Warnings, Adverse reactionsExact identifier
application number: M007
Epsom SaltMAGNESIUM SULFATEMeijer, Inc.3b8eae67-9e27-46bd-ab2b-02c719786bab2026-02-19Warnings, Adverse reactionsExact identifier
application number: M007
Castor OilCASTOR OILMeijer, Inc.c4d03837-193b-4817-8b78-fbdfb9122f192026-02-19Warnings, Adverse reactionsExact identifier
application number: M007
Epsom SaltMAGNESIUM SULFATEMeijer, Inc.2070a4a6-7968-49f2-84ec-53bd1cd824452026-02-19Warnings, Adverse reactionsExact identifier
application number: M007
Mineral OilMINERAL OILMeijer, Inc.652d1da9-a71f-4113-9ef3-da09167246252026-02-19Warnings, Adverse reactionsExact identifier
application number: M007
SENNA-SDOCUSATE SODIUM AND SENNOSIDESAdvanced Rx LLCd148be81-79b4-41f7-b8d8-a0e85b6615922026-02-18WarningsExact identifier
application number: M007
citromaMAGNESIUM CITRATETarget Corporationa8e52a22-7c30-40c0-8f78-523775743bfb2026-02-18Warnings, Adverse reactionsExact identifier
application number: M007
Mineral OilMINERAL OILTarget Corporation526508f0-e908-4e3d-88f5-404a95f6de762026-02-18Warnings, Adverse reactionsExact identifier
application number: M007
CVS PharmacySALINE LAXATIVECVS Pharmacyedd58c52-18de-4ec4-aec3-44f3e17607a72026-02-17WarningsExact identifier
application number: M007