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 23 of 42 · 833 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MILK OF MAGNESIAMAGNESIUM HYDROXIDEH E Bab995d9a-1e40-2b38-e053-2a95a90a87e42025-08-21WarningsExact identifier
application number: M007
SenokotSTANDARDIZED SENNA CONCENTRATEAtlantis Consumer Healthcare, Inc.d5bf67e5-82c6-edbf-e9ec-e027fdd47c842025-08-20WarningsExact identifier
application number: M007
Stool SoftenerDOCUSATE SODIUMBJWC (Berkley & Jensen / BJ's)330758d2-fc1a-50ce-e063-6294a90a7db12025-08-19WarningsExact identifier
application number: M007
Sennosides and Docusate SodiumSENNOSIDES AND DOCUSATE SODIUMAmerican Health Packaging4b84d5d7-43cf-47bb-af59-088550c3a0bc2025-08-12WarningsExact identifier
application number: M007
Stool Softener LaxativeDOCUSATE SODIUMGood Sense (Geiss, Destin & Dunn, Inc.)8066a52d-e683-47c1-905c-290d2d427acf2025-08-12WarningsExact identifier
application number: M007
ProlaxaDOCUSATE SODIUM 250MGAdvanced Rx of Tennessee, LLC3ba0c0d9-9e6f-a2e6-e063-6394a90a202d2025-08-05WarningsExact identifier
application number: M007
Dulcolax Stool SoftenerDOCUSATE SODIUMChattem, Inc.86cb7102-3585-4757-9c37-5bf9776bbe632025-08-01WarningsExact identifier
application number: M007
LEADER Mineral OilMINERAL OILCardinal Health, 110 dba Leader7d4f8fa3-8203-5523-e053-2991aa0aba1a2025-07-28WarningsExact identifier
application number: M007
Rapidol Sal InglesaMAGNESIUM SULFATE HEPTAHYDRATEPharmadel LLC1d4ef5f0-54c5-4838-e063-6394a90a44a82025-07-28WarningsExact identifier
application number: M007
Enemeez KidsDOCUSATE SODIUMQuest Products LLCf1602ba4-ad02-2936-e053-2995a90a27f22025-07-15WarningsExact identifier
application number: M007
SennosidesSENNOSIDESBryant Ranch Prepackd4ab04e4-b78a-4afc-aa16-d9dc8fb6cc102025-07-14WarningsExact identifier
application number: M007
Epsom SaltEPSOM SALTStrategic Sourcing Services LLC1515fadd-a7a5-4502-afe2-cfcd50d5bfc82025-07-11WarningsExact identifier
application number: M007
Quality Choice Fiber CapletsCALCIUM POLYCARBOPHILQUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)29dbc831-23c1-487d-902a-9404d9ebe8052025-07-09WarningsExact identifier
application number: M007
Rexall Ready to use 4pk LAXATIVESODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM AND SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORMDolgencorp, LLC78509915-0ef1-4238-99a5-78a49a68f98f2025-07-07WarningsExact identifier
application number: M007
Sal Inglesa EPSOM SALTMAGNESIUM SULFATE HEPTAHYDRATEMenper Distributors, Inc247aa3a3-d38f-4799-b44d-dfe18324fd0c2025-07-01WarningsExact identifier
application number: M007
Stool Softener Extra StrengthDOCUSATE SODIUMChain Drug Consortium, LLC550000ba-0d6d-4666-8461-f591c14478b12025-06-27WarningsExact identifier
application number: M007
Epsom SaltMAGNESIUM SULFATEChain Drug Consortium, LLCc9807e6e-9dcc-41a2-8956-b61623ac21762025-06-27WarningsExact identifier
application number: M007
Stool Softener LaxativeDOCUSATE SODIUMChain Drug Consortium, LLC09449649-fd57-4446-8264-6c3bdd6621d02025-06-27WarningsExact identifier
application number: M007
SennaSENNOSIDESBryant Ranch Prepackf2b14378-2b60-4533-b232-8c8647fbce782025-06-26WarningsExact identifier
application number: M007
Stool Softener LaxativeDOCUSATE SODIUMTARGET CORPORATION28fce2e2-2101-df88-e063-6394a90aa3de2025-06-25WarningsExact identifier
application number: M007