FDA.reportPublic FDA data

Docusate Sodium

Product NDC
63187-476
11-digit product format
631870476
Labeler code
63187
Product ID
63187-476_5c0507c4-d04d-4453-b688-fa1d856f751d
Type
HUMAN OTC DRUG
Nonproprietary name
Docusate Sodium
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
Proficient Rx LP
Application
M007
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2010-09-15
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
Docusate Sodium
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
f9ac0344-5864-4ac1-81bc-16878a5946c5Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63187-476-00Docusate Sodium100 in 1 BOTTLECAPSULE, LIQUID FILLED1004
63187-476-30Docusate Sodium30 in 1 BOTTLECAPSULE, LIQUID FILLED304
63187-476-60Docusate Sodium60 in 1 BOTTLECAPSULE, LIQUID FILLED604
63187-476-90Docusate Sodium90 in 1 BOTTLECAPSULE, LIQUID FILLED904

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Docusate SodiumACTIVE INGREDIENTF05Q2T2JA0DOCUSATE SODIUM CAPSULE, LIQUID FILLED [PROFICIENT RX LP]1
DocusateACTIVE MOIETYM7P27195AGDOCUSATE SODIUM CAPSULE, LIQUID FILLED [PROFICIENT RX LP]1
D&C RED NO. 33INACTIVE INGREDIENT9DBA0SBB0LDOCUSATE SODIUM CAPSULE, LIQUID FILLED [PROFICIENT RX LP]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOADOCUSATE SODIUM CAPSULE, LIQUID FILLED [PROFICIENT RX LP]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8DOCUSATE SODIUM CAPSULE, LIQUID FILLED [PROFICIENT RX LP]1
GELATININACTIVE INGREDIENT2G86QN327LDOCUSATE SODIUM CAPSULE, LIQUID FILLED [PROFICIENT RX LP]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXDOCUSATE SODIUM CAPSULE, LIQUID FILLED [PROFICIENT RX LP]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ADOCUSATE SODIUM CAPSULE, LIQUID FILLED [PROFICIENT RX LP]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3DOCUSATE SODIUM CAPSULE, LIQUID FILLED [PROFICIENT RX LP]1
SORBITOLINACTIVE INGREDIENT506T60A25RDOCUSATE SODIUM CAPSULE, LIQUID FILLED [PROFICIENT RX LP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-476DOCUSATE SODIUM CAPSULE, LIQUID FILLED [PROFICIENT RX LP]4Current NDC, Legacy NDC, 4 package rows20240216_f9ac0344-5864-4ac1-81bc-16878a5946c5.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 CapsulePSNf9ac0344-5864-4ac1-81bc-16878a5946c54
1115005docusate sodium 100 MG Oral CapsuleSCDf9ac0344-5864-4ac1-81bc-16878a5946c54
1115005DOSS Sodium 100 MG Oral CapsuleSYf9ac0344-5864-4ac1-81bc-16878a5946c54

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63187-476-0063187047600100 CAPSULE, LIQUID FILLED in 1 BOTTLE (63187-476-00) 2019-01-010000-00-00NoNoCurrent
63187-476-306318704763030 CAPSULE, LIQUID FILLED in 1 BOTTLE (63187-476-30) 2019-01-010000-00-00NoNoCurrent
63187-476-606318704766060 CAPSULE, LIQUID FILLED in 1 BOTTLE (63187-476-60) 2019-01-010000-00-00NoNoCurrent
63187-476-906318704769090 CAPSULE, LIQUID FILLED in 1 BOTTLE (63187-476-90) 2019-01-010000-00-00NoNoCurrent