Stool Softener

Product NDC
85111-401
11-digit product format
851110401
Labeler code
85111
Product ID
85111-401_44fbb054-2c67-2bdd-e063-6294a90ad938
Type
HUMAN OTC DRUG
Nonproprietary name
Docusate Sodium
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
RMT HEALTH LLC
Application
M007
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-09-01
Substance
DOCUSATE SODIUM
Active strength
100 mg/1
NDC exclude flag
No
Listing certified through
2026-12-31
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
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DOCUSATE SODIUM100 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
F05Q2T2JA0Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1115005Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
44fbb197-fe90-c5a8-e063-6394a90adb7dAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85111-401-10Stool Softener1000 in 1 BOTTLECAPSULE, LIQUID FILLED10001
85111-401-50Stool Softener500 in 1 BOTTLECAPSULE, LIQUID FILLED5001

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 · 833 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Well at Walgreens Castor OilCASTOR OILWalgreen Co.e41f8553-3812-4d0b-95f8-20b2612792992026-02-12Warnings, Adverse reactionsExact identifier
application number: M007
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1115005docusate sodium 100 MG Oral CapsulePSN44fbb197-fe90-c5a8-e063-6394a90adb7d1
1115005docusate sodium 100 MG Oral CapsuleSCD44fbb197-fe90-c5a8-e063-6394a90adb7d1
1115005DOSS Sodium 100 MG Oral CapsuleSY44fbb197-fe90-c5a8-e063-6394a90adb7d1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
85111-401-10851110401101000 CAPSULE, LIQUID FILLED in 1 BOTTLE (85111-401-10) 2025-09-01NoNoCurrent
85111-401-5085111040150500 CAPSULE, LIQUID FILLED in 1 BOTTLE (85111-401-50) 2025-09-01NoNoCurrent