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 11 of 42 · 833 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Mineral OilMINERAL OILUnited Natural Foods, Inc. dba UNFIcb7bc571-295f-47c2-ae93-18cba194752c2026-02-17Warnings, Adverse reactionsExact identifier
application number: M007
Mineral OilMINERAL OILStrategic Sourcing Services LLCe4965086-dcc0-4b34-bb30-81facf7139f32026-02-17Warnings, Adverse reactionsExact identifier
application number: M007
Magnesium CitrateMAGNESIUM CITRATEValu Merchandisers Companycd3e5836-b2f0-41f3-8623-3105c46424912026-02-16Warnings, Adverse reactionsExact identifier
application number: M007
citromaMAGESIUM CITRATEValu Merchandisers Companya693f6b0-0679-4609-9ca0-dddfa4158c022026-02-16Warnings, Adverse reactionsExact identifier
application number: M007
citromaMAGNESIUM CITRATEValu Merchandisers Companyfb358bc3-e479-42e7-8aea-a6a3676f24302026-02-16Warnings, Adverse reactionsExact identifier
application number: M007
Epsom SaltMAGNESIUM SULFATEValu Merchandisers Companyff539c1c-9ed3-49be-9b30-1858f12e1e902026-02-16Warnings, Adverse reactionsExact identifier
application number: M007
Castor OilCASTOR OILUnited Natural Foods, Inc. dba UNFIbd19bea3-5ac9-4f8d-b1a0-478fd9c8a01f2026-02-16Warnings, Adverse reactionsExact identifier
application number: M007
Walgreens SmoothLAX Soft ChewsMAGNESIUM HYDROXIDEWalgreens424e27ce-0b11-9cd2-e063-6294a90a3c212026-02-16WarningsExact identifier
application number: M007
citromaMAGNESIUM CITRATEUnited Natural Foods, Inc. dba UNFIda013c15-3531-4dc5-b122-bfc99bc494ae2026-02-16Warnings, Adverse reactionsExact identifier
application number: M007
citromaMAGNESIUM CITRATEUnited Natural Foods, Inc. dba UNFIdb1bc651-1a35-4f92-a917-c6a19f4215942026-02-16Warnings, Adverse reactionsExact identifier
application number: M007
Stool Softener LaxativeDOCUSATE SODIUMThe Kroger Co.e1a68bd9-d31a-46a6-8c08-7ad8197b6e0b2026-02-13WarningsExact identifier
application number: M007
Epsom SaltMAGNESIUM SULFATETopco Associates LLCb2ec06b3-647d-49ab-a392-6db63d96d1e32026-02-13Warnings, Adverse reactionsExact identifier
application number: M007
Castor OilCASTOR OILTopco Associates LLC5643f2e0-93e2-4c2e-90a0-fd152150d18a2026-02-13Warnings, Adverse reactionsExact identifier
application number: M007
citromaMAGESIUM CITRATETopco Associates LLCd3cc7cb6-098e-413c-b1ad-7ebf5fa352692026-02-13Warnings, Adverse reactionsExact identifier
application number: M007
citromaMAGNESIUM CITRATETopco Associates LLCbc89c4bc-5207-479d-9a3b-e570b412a7ba2026-02-13Warnings, Adverse reactionsExact identifier
application number: M007
Epsom SaltMAGNESIUM SULFATETopco Associates LLC72f69aa0-381a-4e5c-975d-3a73fdc1b3772026-02-13Warnings, Adverse reactionsExact identifier
application number: M007
Mineral OilMINERAL OILTopco Associates LLCe9b1fd61-c229-4529-82c2-d6ac5b0760822026-02-13WarningsExact identifier
application number: M007
Magnesium CitrateMAGNESIUM CITRATEPinnacle RX LLC4abbb0e4-e005-bc4e-e063-6394a90a126a2026-02-13Warnings, Adverse reactionsExact identifier
application number: M007
365 Whole Foods Market Epsom SaltMAGNESIUM SULFATEWhole Foods Market, Inc.4147cdd0-57f6-3857-e063-6394a90afecb2026-02-12Warnings, Adverse reactionsExact identifier
application number: M007
Epsom SaltMAGNESIUM SULFATEYour Military Exchanges27cff497-123c-424a-9c43-57740c00168b2026-02-12Warnings, Adverse reactionsExact 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