FDA.reportPublic FDA data

Stool Softener

Product NDC
36800-084
11-digit product format
368000084
Labeler code
36800
Product ID
36800-084_a1ec806f-8477-4eb3-ae91-ea2e29530f1e
Type
HUMAN OTC DRUG
Nonproprietary name
docusate sodium and sennosides
Dosage form
TABLET
Route
ORAL
Labeler
TOP CARE (Topco Associates LLC)
Application
M007
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2016-01-31
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 Laxative
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
3b184800-649b-45d0-9586-8055d6d7fe08Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
36800-084-01Stool SoftenerPlus Stimulant Laxative100 in 1 BOTTLE, PLASTICTABLET1005
36800-084-01Stool SoftenerPlus Stimulant Laxative1 in 1 BOXTABLET15

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
36800-084-01EA - Each36800-08434660ce1-01f6-4770-b186-cbf01104fc2a12020-04-20

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
36800-084STOOL SOFTENER PLUS STIMULANT LAXATIVE (DOCUSATE SODIUM AND SENNOSIDES) TABLET [TOP CARE (TOPCO ASSOCIATES LLC)]5Current NDC, Legacy NDC, 2 package rows20240621_3b184800-649b-45d0-9586-8055d6d7fe08.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 13 of 42 · 833 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Epsom SaltMAGNESIUM SULFATESam's West, Inc6edb7688-0a64-4a7e-a0c0-9f75c96682fe2026-02-03WarningsExact identifier
application number: M007
Stool Softener LaxativeDOCUSATE SODIUMEQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)cb2698b1-6c58-417f-ae86-74fbe38146262026-02-03WarningsExact identifier
application number: M007
Castor OilCASTOR OILCVS Pharmacy, Inc.f20de8f2-3637-4485-8b80-0a12fd5e651c2026-02-02Warnings, Adverse reactionsExact identifier
application number: M007
Magnesium CitrateMAGNESIUM CITRATECVS Pharmacy, Inc.1dca8f4a-f544-4ae5-bb0a-8b671d4a488a2026-02-02Warnings, Adverse reactionsExact identifier
application number: M007
citromaMAGNESIUM CITRATECVS Pharmacy, Inc.15a9996d-7391-41f8-ab15-27ee2a6a60e42026-02-02Warnings, Adverse reactionsExact identifier
application number: M007
citromaMAGESIUM CITRATERite Aid Corporatione562bf42-b9e1-4ea8-b880-7bec4dd620b42026-01-30Warnings, Adverse reactionsExact identifier
application number: M007
SENNA-SDOCUSATE SODIUM AND SENNOSIDESStrategic Sourcing Services, LLC905bd658-a0af-4f20-be3d-00c54868a26c2026-01-29WarningsExact identifier
application number: M007
Senna LaxativeSENNOSIDESStrategic Sourcing Services LLC9248a907-a8bd-47d5-98a2-48534d6023d42026-01-29WarningsExact identifier
application number: M007
Leader Castor OilCASTOR OILCardinal Health, 110 dba Leader49e3a40a-b717-43f6-abed-473d7ed03c2e2026-01-29Warnings, Adverse reactionsExact identifier
application number: M007
Mineral OilMINERAL OILCARDINAL HEALTH 110, LLC. DBA LEADER803f444f-d136-4f06-9842-24a71a3d7d6b2026-01-29Warnings, Adverse reactionsExact identifier
application number: M007
Equate Ready-to-Use Enema LaxativeSODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM AND SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORMWalMart04c7440e-5b25-4b63-9604-321298d510212026-01-29WarningsExact identifier
application number: M007
Stool Softener LaxativeDOCUSATE SODIUMMeijer Distribution Inc.81edf0d8-b6f3-4b3a-85db-0108160756b12026-01-28WarningsExact identifier
application number: M007
Quality Choice LaxativeSODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM AND SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORMChain Drug Marketing Association1cac3b6b-155b-47bb-bb79-17c55d3457362026-01-28WarningsExact identifier
application number: M007
Docusate Sodium and SennosidesDOCUSATE SODIUM AND SENNOSIDESSOFTGEL HEALTHCARE PRIVATE LIMITED1ad73079-ebb3-dae7-e063-6294a90a05582026-01-28WarningsExact identifier
application number: M007
DOCUSATE SODIUM 100MGDOCUSATE SODIUM 100MGFarmacias De Similares TX LLC44269b79-a5ad-f443-e063-6294a90a84732026-01-28WarningsExact identifier
application number: M007
Docusate Sodium and SennosidesDOCUSATE SODIUM AND SENNOSIDESSOFTGEL HEALTHCARE PRIVATE LIMITED19830f9a-27b1-910d-e063-6294a90adace2026-01-27WarningsExact identifier
application number: M007
SennosidesSENNOSIDESSOFTGEL HEALTHCARE PRIVATE LIMITED94936bd4-8bbf-6211-e053-2995a90a21382026-01-27Exact identifier
application number: M007
SennosidesSENNOSIDESSoftgel Healthcare Pvt Ltd16582306-7321-6c7c-e063-6394a90a509e2026-01-27WarningsExact identifier
application number: M007
Vegetable LaxativeSENNOSIDESWal-Mart Stores Inc97695092-1ded-4723-a015-fdadd7c28c812026-01-27WarningsExact identifier
application number: M007
Calcium PolycarbophilCALCIUM POLYCARBOPHILCVS Pharmacy, Incc3de1c1b-5042-aec3-e053-2a95a90ad1342026-01-27WarningsExact identifier
application number: M007

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
998740sennosides 8.6 MG / docusate sodium 50 MG Oral TabletPSN3b184800-649b-45d0-9586-8055d6d7fe085
998740docusate sodium 50 MG / sennosides, USP 8.6 MG Oral TabletSCD3b184800-649b-45d0-9586-8055d6d7fe085
998740DOSS Sodium 50 MG / sennosides, USP 8.6 MG Oral TabletSY3b184800-649b-45d0-9586-8055d6d7fe085

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
36800-084-01368000084011 BOTTLE, PLASTIC in 1 BOX (36800-084-01) / 100 TABLET in 1 BOTTLE, PLASTIC2016-01-310000-00-00NoNoCurrent