FDA.reportPublic FDA data

Stool Softener Laxative

Product NDC
11673-678
11-digit product format
116730678
Labeler code
11673
Product ID
11673-678_b23dffee-c645-4771-aa44-f8e51e19c6d0
Type
HUMAN OTC DRUG
Nonproprietary name
DOCUSATE SODIUM
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
TARGET Corporation
Application
M007
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2017-08-31
Marketing end
2026-12-28
Substance
DOCUSATE SODIUM
Active strength
100 mg/1
NDC exclude flag
No
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 Laxative

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
4180a35b-cc50-46ae-a100-99bb218c10ffAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11673-678-16Stool Softener Laxative160 in 1 BOTTLE, PLASTICCAPSULE, LIQUID FILLED1606

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11673-678STOOL SOFTENER LAXATIVE (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [TARGET CORPORATION]6Current NDC, Legacy NDC, 1 package rows20231102_4180a35b-cc50-46ae-a100-99bb218c10ff.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 22 of 42 · 833 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Senna SyrupNATURAL VEGETABLE LAXATIVEMethod Pharmaceuticalsce83ba78-7e0d-b37f-e053-2995a90a93832025-10-21WarningsExact identifier
application number: M007
Fiber LaxCALCIUM POLYCARBOPHILPD-Rx Pharmaceuticals, Inc.730198a5-b6d9-4fc7-b053-a7c65a93c5402025-10-20WarningsExact identifier
application number: M007
GlycerinGLYCERINChain Drug Consortium LLC4694f05b-d927-4e15-9630-a0a1cddb3cbb2025-10-16WarningsExact identifier
application number: M007
GlycerinGLYCERINAmerisource Bergen/Good Neighbor Pharmacye6a8914f-cfd9-4c72-abaa-22189bf0faef2025-10-16WarningsExact identifier
application number: M007
GlycerinGLYCERINChain Drug Marketing Association Inc.3386fada-6b7f-46fd-e063-6294a90abffc2025-10-16WarningsExact identifier
application number: M007
Senna SyrupSENNA SYRUPKesin Pharma Corporation360fb98d-c6ad-7bcc-e063-6294a90a94532025-10-14WarningsExact identifier
application number: M007
GlycerinGLYCERINH E B3d0566a1-57a5-6a31-e054-00144ff88e882025-10-09WarningsExact identifier
application number: M007
SENNA WITH DOCUSATE SODIUMDOCUSATE SODIUM AND SENNOSIDESHHH Pharmaceuticals2bbb1b99-d43c-40a3-bc53-e18e8394c3182025-10-08WarningsExact identifier
application number: M007
Castor OilCASTOR OILBIONPHARMA INC.3f9728e8-c7a2-6cfb-e063-6394a90a8f1d2025-10-06WarningsExact identifier
application number: M007
SennosidesSENNOSIDESInvaTech Pharma Solutions LLC3de39fbd-29be-fce7-e063-6394a90a67ae2025-10-03WarningsExact identifier
application number: M007
Metamucil Therapy for regularityPSYLLIUM HUSKThe Procter & Gamble Manufacturing Companya9824f73-5ea2-4a65-a926-3a57561441b82025-10-01WarningsExact identifier
application number: M007
OneLAX SENNASENNAAtlantic Biologicals Corp.40202c76-4273-88fd-e063-6394a90a07b22025-10-01WarningsExact identifier
application number: M007
Magnesium CitrateMAGNESIUM CITRATE ORAL SOLUTIONBionpharma, Inc.4019fbd0-fcf9-77a6-e063-6294a90a5ae72025-09-30WarningsExact identifier
application number: M007
LEADER HYDROCORTISONE WITH ALOEHYDROCORTISONELEADER39916470-15bf-4bd0-96e2-b909d68cf9c42025-09-29WarningsExact identifier
application number: M007
Leader Ready to Use Mineral Oil LaxativeMINERAL OILCardinal Healthb8494d02-8a7d-47b4-80b0-b8ab51b625fd2025-09-29WarningsExact identifier
application number: M007
Leader Ready to Use Saline LaxativeSODIUM PHOSPHATE, DIBASIC AND SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORMCardinal Health1b4f9c28-0547-4922-aa15-990c6fd9dc9f2025-09-29WarningsExact identifier
application number: M007
Milk of MagnesiaMAGNESIUM HYDROXIDEKesin Pharma Corporation3f7cff50-749b-5275-e063-6394a90af4072025-09-23WarningsExact identifier
application number: M007
Stimulant Laxative Plus Stool SoftenerDOCUSATE SODIUM 50 MG AND SENNOSIDES 8.6 MGBryant Ranch Prepack12f613e4-c919-4cc4-a445-eb30039ae45f2025-09-18WarningsExact identifier
application number: M007
Saline LaxativeSALINE LAXATIVEMajor Pharmaceuticalsb3758ffe-1bac-4df6-9714-5e33e9d28d902025-09-16WarningsExact identifier
application number: M007
Gentle LaxativeBISACODYLBETTER LIVING BRANDS LLC.f29d57f6-0938-d459-e053-2995a90ad86b2025-09-13WarningsExact identifier
application number: M007

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1115005docusate sodium 100 MG Oral CapsulePSN4180a35b-cc50-46ae-a100-99bb218c10ff6
1115005docusate sodium 100 MG Oral CapsuleSCD4180a35b-cc50-46ae-a100-99bb218c10ff6
1115005DOSS Sodium 100 MG Oral CapsuleSY4180a35b-cc50-46ae-a100-99bb218c10ff6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
11673-678-1611673067816160 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (11673-678-16) 2017-08-312026-12-28NoNoCurrent