FDA.reportPublic FDA data

Stool Softener Laxative

Product NDC
0904-7280
11-digit product format
009047280
Labeler code
0904
Product ID
0904-7280_9106599b-ff0f-4d97-a4e4-ce9ca098e23c
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
2022-11-15
Substance
DOCUSATE SODIUM
Active strength
100 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 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
97561cd4-63d9-44c2-a3a3-ec668a09a4edAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0904-7280-60Stool Softener Laxative100 in 1 BOTTLE, PLASTICCAPSULE, LIQUID FILLED1009
0904-7280-80Stool Softener Laxative1000 in 1 BOTTLE, PLASTICCAPSULE, LIQUID FILLED10009

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-7280-60EA - Each0904-728026a1e584-5c99-4037-9a6b-ca3b57d707f212023-03-13
0904-7280-80EA - Each0904-7280d88438cf-e71a-4f39-b013-ee79652343c412023-03-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0904-7280STOOL SOFTENER LAXATIVE (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [MAJOR PHARMACEUTICALS]8Current NDC, Legacy NDC, 2 package rows20240904_97561cd4-63d9-44c2-a3a3-ec668a09a4ed.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
1115005docusate sodium 100 MG Oral CapsulePSNd616685a-11fc-4ae0-80de-7d25c0d71ee9104
1115005docusate sodium 100 MG Oral CapsuleSCDd616685a-11fc-4ae0-80de-7d25c0d71ee9104
1115005DOSS Sodium 100 MG Oral CapsuleSYd616685a-11fc-4ae0-80de-7d25c0d71ee9104
1115005docusate sodium 100 MG Oral CapsulePSN5d300ea7-78eb-4e19-8333-1e42c73c4c5410
1115005docusate sodium 100 MG Oral CapsuleSCD5d300ea7-78eb-4e19-8333-1e42c73c4c5410
1115005DOSS Sodium 100 MG Oral CapsuleSY5d300ea7-78eb-4e19-8333-1e42c73c4c5410
1115005docusate sodium 100 MG Oral CapsulePSN97561cd4-63d9-44c2-a3a3-ec668a09a4ed9
1115005docusate sodium 100 MG Oral CapsuleSCD97561cd4-63d9-44c2-a3a3-ec668a09a4ed9
1115005DOSS Sodium 100 MG Oral CapsuleSY97561cd4-63d9-44c2-a3a3-ec668a09a4ed9
1115005docusate sodium 100 MG Oral CapsulePSN867a7771-6846-427d-b526-b964d74f77004
1115005docusate sodium 100 MG Oral CapsuleSCD867a7771-6846-427d-b526-b964d74f77004
1115005DOSS Sodium 100 MG Oral CapsuleSY867a7771-6846-427d-b526-b964d74f77004
1115005docusate sodium 100 MG Oral CapsulePSN4d678da0-9ada-4d00-9db9-33b45c7761073
1115005docusate sodium 100 MG Oral CapsuleSCD4d678da0-9ada-4d00-9db9-33b45c7761073
1115005DOSS Sodium 100 MG Oral CapsuleSY4d678da0-9ada-4d00-9db9-33b45c7761073
1115005docusate sodium 100 MG Oral CapsulePSNccfa095c-77f0-41ff-84f8-e02d983c7c742
1115005docusate sodium 100 MG Oral CapsulePSNfdf3c8e1-d554-4cdb-e053-6394a90a542e2
1115005docusate sodium 100 MG Oral CapsuleSCDccfa095c-77f0-41ff-84f8-e02d983c7c742
1115005docusate sodium 100 MG Oral CapsuleSCDfdf3c8e1-d554-4cdb-e053-6394a90a542e2
1115005DOSS Sodium 100 MG Oral CapsuleSYfdf3c8e1-d554-4cdb-e053-6394a90a542e2
1115005DOSS Sodium 100 MG Oral CapsuleSYccfa095c-77f0-41ff-84f8-e02d983c7c742
1115005docusate sodium 100 MG Oral CapsulePSN2c65319f-6cf5-aa90-e063-6394a90ad6621
1115005docusate sodium 100 MG Oral CapsuleSCD2c65319f-6cf5-aa90-e063-6394a90ad6621
1115005DOSS Sodium 100 MG Oral CapsuleSY2c65319f-6cf5-aa90-e063-6394a90ad6621

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0904-7280-6000904728060100 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (0904-7280-60) 2022-11-150000-00-00NoNoCurrent
0904-7280-80009047280801000 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (0904-7280-80) 2022-11-150000-00-00NoNoCurrent