FDA.reportPublic FDA data

Stool Softener plus Stimulant Laxative

Product NDC
70000-0526
11-digit product format
700000526
Labeler code
70000
Product ID
70000-0526_b33fb5f0-197e-4a91-b324-af6a97c29f53
Type
HUMAN OTC DRUG
Nonproprietary name
Docusate Sodium 50 mg and Sennosides 8.6 mg
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
CARDINAL HEALTH, 110 DBA LEADER
Application
M007
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2019-10-23
Substance
SENNOSIDES; DOCUSATE SODIUM
Active strength
8.6; 50 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 plus Stimulant Laxative
Listing expiration
2027-12-31

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
3fd9ba76-42f8-4ebe-b1bc-f81f08e702ceAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70000-0526-1Stool Softener plus Stimulant Laxative100 in 1 BOTTLE, PLASTICTABLET, FILM COATED1005
70000-0526-2Stool Softener plus Stimulant Laxative200 in 1 BOTTLE, PLASTICTABLET, FILM COATED2005

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70000-0526-1EA - Each70000-05264cfc67a7-a920-4617-b601-6a7e5d00239012020-02-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70000-0526STOOL SOFTENER PLUS STIMULANT LAXATIVE (DOCUSATE SODIUM 50 MG AND SENNOSIDES 8.6 MG) TABLET, FILM COATED [CARDINAL HEALTH, 110 DBA LEADER]3Current NDC, Legacy NDC, 2 package rows20241226_3fd9ba76-42f8-4ebe-b1bc-f81f08e702ce.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 12 of 42 · 829 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Epsom SaltMAGNESIUM SULFATEWalgreen Co.b5a02809-6e01-4e01-b1c3-2b10c5091a4e2026-02-12Warnings, Adverse reactionsExact identifier
application number: M007
Mineral OilMINERAL OILWalgreen Co.822fd02a-92b0-4010-8bfb-737dba331d542026-02-12Warnings, Adverse reactionsExact identifier
application number: M007
MILK OF MAGNESIA MINTMAGNESIUM HYDROXIDERugby Laboratories5fd89979-903e-4b31-872d-3b8974af3a6b2026-02-09WarningsExact identifier
application number: M007
Epsom SaltEPSOM SALTEQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)1845ea0c-0cb6-482b-abe6-fa17785c5b902026-02-09WarningsExact identifier
application number: M007
Colace Fast-Acting Saline LaxativeMAGNESIUM HYDROXIDEAtlantis Consumer Healthcare, Inc.572adfaf-6e26-42e5-b65d-6d356a0bdfa92026-02-06WarningsExact identifier
application number: M007
Castor OilCASTOR OILRetail Business Services, LLC4e9c41fa-f240-4986-bb13-541bfeb0e50b2026-02-06WarningsExact identifier
application number: M007
citromaMAGNESIUM CITRATERetail Business Services, LLCf3661952-ef4f-4f29-93e6-ec09b84643652026-02-06Warnings, Adverse reactionsExact identifier
application number: M007
citromaMAGNESIUM CITRATERetail Business Services, LLC2f6e9f87-4bff-482b-a54f-f51ca99aac8c2026-02-06Warnings, Adverse reactionsExact identifier
application number: M007
Epsom SaltMAGNESIUM SULFATERetail Business Services, LLC1a8b540c-b66e-4dca-b7af-23705ae247b62026-02-06Warnings, Adverse reactionsExact identifier
application number: M007
Mineral OilMINERAL OILRetail Business Services, LLCb0abcdf9-c226-424f-8970-c2135708c6c82026-02-06Warnings, Adverse reactionsExact identifier
application number: M007
Epsom SaltMAGNESIUM SULFATEPublix Super Markets, Inc.e985e071-5541-456e-ae4d-dba85287fe752026-02-05Warnings, Adverse reactionsExact identifier
application number: M007
citromaMAGNESIUM CITRATEDiscount Drug Marta82a4aa9-c8af-4383-9d92-ba6c596f00952026-02-04WarningsExact identifier
application number: M007
Epsom SaltMAGNESIUM SULFATEDiscount Drug Martb05a94d2-5cc6-4989-9fb8-096e54fa78522026-02-04Warnings, Adverse reactionsExact identifier
application number: M007
Epsom SaltMAGNESIUM SULFATEGrocery Outlet, Inc.3dff4b00-e71a-1dc0-e063-6394a90a715f2026-02-04Warnings, Adverse reactionsExact identifier
application number: M007
Epsom SaltMAGNESIUM SULFATEHARRIS TEETER73065a04-b7cd-437d-9624-f845f5ec93bf2026-02-04Warnings, Adverse reactionsExact identifier
application number: M007
Harris TeeterMINERALHarris Teeter401e3a7e-54be-47cc-88c3-a343f5cbbd102026-02-04Warnings, Adverse reactionsExact identifier
application number: M007
Magnesium CitrateMAGNESIUM CITRATEHy-Vee, Inc.45374a86-80a4-481c-e063-6294a90a381a2026-02-04Warnings, Adverse reactionsExact identifier
application number: M007
Epsom SaltMAGNESIUM SULFATEHy-Vee, Inc.44592ee0-13dd-57b1-e063-6394a90ab4022026-02-04Warnings, Adverse reactionsExact identifier
application number: M007
Epsom SaltMAGNESIUM SULFATECVS Pharmacy, Inc.a78d991a-ba21-4bc4-b8f9-f8dafbddc28f2026-02-03Warnings, Adverse reactionsExact identifier
application number: M007
Epsom SaltMAGNESIUM SULFATESam's West, Inc6edb7688-0a64-4a7e-a0c0-9f75c96682fe2026-02-03WarningsExact identifier
application number: M007

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
998740sennosides 8.6 MG / docusate sodium 50 MG Oral TabletPSN3fd9ba76-42f8-4ebe-b1bc-f81f08e702ce5
998740docusate sodium 50 MG / sennosides, USP 8.6 MG Oral TabletSCD3fd9ba76-42f8-4ebe-b1bc-f81f08e702ce5
998740DOSS Sodium 50 MG / sennosides, USP 8.6 MG Oral TabletSY3fd9ba76-42f8-4ebe-b1bc-f81f08e702ce5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70000-0526-170000052601100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70000-0526-1) 2019-10-230000-00-00NoNoCurrent
70000-0526-270000052602200 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70000-0526-2) 2025-12-23NoNoCurrent