FDA.reportPublic FDA data

Stool Softener Laxative

Product NDC
0904-7281
11-digit product format
009047281
Labeler code
0904
Product ID
0904-7281_36a66686-4001-4987-bbf4-8291d20c52d4
Type
HUMAN OTC DRUG
Nonproprietary name
Docusate Sodium
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
Major Pharmaceuticals
Application
M007
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-10-14
Substance
DOCUSATE SODIUM
Active strength
250 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 Laxative
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DOCUSATE SODIUM250 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
1245468Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
93ef6486-0930-41e3-a2c6-44af7e37e98bAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0904-7281-60Stool Softener Laxative100 in 1 BOTTLE, PLASTICCAPSULE, LIQUID FILLED1007
0904-7281-80Stool Softener Laxative1000 in 1 BOTTLE, PLASTICCAPSULE, LIQUID FILLED10007

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-7281-60EA - Each0904-7281b2630097-6a2c-4a41-a669-a69453258fb312023-07-06
0904-7281-80EA - Each0904-7281ad308384-bdc4-4d4a-a0ce-73bb81d2b06012023-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0904-7281STOOL SOFTENER LAXATIVE (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [MAJOR PHARMACEUTICALS]5Current NDC, Legacy NDC, 2 package rows20241219_93ef6486-0930-41e3-a2c6-44af7e37e98b.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 33 of 42 · 833 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Stratuscare Glycerin Laxative PediatricGLYCERINStratus Pharmaceuticals6ae6d3c4-bb3b-4436-b76d-8654bf871e662024-11-01WarningsExact identifier
application number: M007
Rite Aid Fiber TherapyMETHYLCELLULOSERITE AID CORPORATIONe50cea80-c020-4b85-b61f-d053f11f479b2024-10-30WarningsExact identifier
application number: M007
Rite Aid Fiber CapletsCALCIUM POLYCARBOPHILRITE AID CORPORATION06e46cb0-2928-479e-984d-2305fff995e02024-10-30WarningsExact identifier
application number: M007
Premier Value Orange FlavorPSYLLIUM HUSKPHARMACY VALUE ALLIANCE, LLC2d580965-2bef-46ee-8532-fbe34330a4b42024-10-28WarningsExact identifier
application number: M007
Premier Value Fiber TherapyMETHYLCELLULOSEPHARMACY VALUE ALLIANCE, LLCb875d5f8-02f3-4474-9fda-83091bc7de042024-10-28WarningsExact identifier
application number: M007
Premier Value Fiber Therapy Original CoarsePSYLLIUM HUSKPHARMACY VALUE ALLIANCE, LLC8c85a13d-ae99-4599-9a28-c3965caa63762024-10-28WarningsExact identifier
application number: M007
Premier ValueCALCIUM POLYCARBOPHILPHARMACY VALUE ALLIANCE, LLC4d766548-00d0-41bd-bb58-b69e037c77e22024-10-28WarningsExact identifier
application number: M007
Premier Value FiberPSYLLIUM HUSKChain Drug Consortium, LLCc507fe4a-1f8e-4780-a2f5-9da6e5922bef2024-10-28WarningsExact identifier
application number: M007
Premier Value Fiber Therapy Orange FlavorPSYLLIUM HUSKPHARMACY VALUE ALLIANCE, LLC85651bd7-e959-4455-a5ed-bd0223ce05632024-10-28WarningsExact identifier
application number: M007
Stool SoftenerDOCUSATE SODIUM AND SENNOSIDESBETTER LIVING BRANDS LLC.f2c61c71-9a23-4bd3-e053-2a95a90ad4602024-10-26WarningsExact identifier
application number: M007
Pedia-LaxGLYCERINC.B. Fleet Company, Inc.ae367381-7146-4307-823d-2bb44c1d42002024-10-25WarningsExact identifier
application number: M007
Epsom SaltMAGNESIUM SULFATETarget Corporationf7309f4a-f1f5-420e-bfc7-fb4495a5afba2024-10-24WarningsExact identifier
application number: M007
Epsom SaltMAGNESIUM SULFATETarget Corporation2540ae39-2218-0f6a-e063-6294a90a5efc2024-10-24WarningsExact identifier
application number: M007
DOCUSATE SODIUMDOCUSATE SODIUMSam's West Incb0e99ebb-41fc-459f-86d2-f0e3527f97b02024-10-24WarningsExact identifier
application number: M007
Stool SoftenerDOCUSATE SODIUMA-S Medication Solutionsef05ad45-7082-43e6-9533-a79c5aa0f3732024-10-22WarningsExact identifier
application number: M007
Bliss GVS ChildrenGLYCERINBliss GVS Pharma Limited03237ed2-265f-4acd-b504-d82b9263287c2024-10-17WarningsExact identifier
application number: M007
NATURAL Epsom SaltMAGNESIUM SULFATEUniversal Distribution Center LLCb2682e51-ffa4-4556-b2a6-b0dbd543fd4f2024-10-16WarningsExact identifier
application number: M007
Bliss GVSGLYCERINBliss GVS Pharma Limited1a3982a1-9ce9-4a1a-ba73-ebe2d86471092024-10-10WarningsExact identifier
application number: M007
BisacodylBISACODYLPadagis US LLC7eada0fc-5f83-43da-a56f-b0f5372982082024-10-10WarningsExact identifier
application number: M007
exchange select stool softenerDOCUSATE SODIUMArmy & Air Force Exchange Service14985848-d791-42b9-ad7e-810a85bb1ee12024-10-07WarningsExact identifier
application number: M007

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1245468docusate sodium 250 MG Oral CapsulePSN93ef6486-0930-41e3-a2c6-44af7e37e98b7
1245468docusate sodium 250 MG Oral CapsuleSCD93ef6486-0930-41e3-a2c6-44af7e37e98b7
1245468DOSS Sodium 250 MG Oral CapsuleSY93ef6486-0930-41e3-a2c6-44af7e37e98b7
1245468docusate sodium 250 MG Oral CapsulePSNc1f588d0-4600-4b97-b2d3-2c08ac351e072
1245468docusate sodium 250 MG Oral CapsuleSCDc1f588d0-4600-4b97-b2d3-2c08ac351e072
1245468DOSS Sodium 250 MG Oral CapsuleSYc1f588d0-4600-4b97-b2d3-2c08ac351e072

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0904-7281-6000904728160100 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (0904-7281-60) 2022-10-140000-00-00NoNoCurrent
0904-7281-80009047281801000 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (0904-7281-80) 2022-10-140000-00-00NoNoCurrent