FDA.reportPublic FDA data

Stool Softener Laxative

Product NDC
0363-4100
11-digit product format
003634100
Labeler code
0363
Product ID
0363-4100_dba5a864-8145-44a3-8c89-42870b53ad19
Type
HUMAN OTC DRUG
Nonproprietary name
Docusate Sodium
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
Walgreens
Application
M007
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-12-31
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
92df761b-da68-4ce9-b02a-a5a74fd6620eAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0363-4100-20Stool Softener Laxative200 in 1 BOTTLE, PLASTICCAPSULE, LIQUID FILLED2008
0363-4100-40Stool Softener Laxative400 in 1 BOTTLE, PLASTICCAPSULE, LIQUID FILLED4008
0363-4100-60Stool Softener Laxative1 in 1 BOXCAPSULE, LIQUID FILLED18
0363-4100-60Stool Softener Laxative60 in 1 BOTTLE, PLASTICCAPSULE, LIQUID FILLED608

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0363-4100-40EA - Each0363-410080e6ceb4-bbdf-4dd4-bef6-991983e510ac12023-04-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-4100STOOL SOFTENER LAXATIVE (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [WALGREENS]5Current NDC, Legacy NDC, 4 package rows20231020_92df761b-da68-4ce9-b02a-a5a74fd6620e.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 16 of 42 · 833 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Senna-SDOCUSATE SODIUM 50MG AND SENNOSIDES 8.6MGWalgreens36cc3a5b-1891-d39e-e063-6294a90a93b42025-12-31WarningsExact identifier
application number: M007
Senna LiquidSENNOSIDESRUGBY LABORATORIES8123b092-2ae9-459b-ae06-6ceb837adcf82025-12-30WarningsExact identifier
application number: M007
Docusate Sodium LiquidDOCUSATE SODIUMRUGBY LABORATORIESe21d19d8-6c2d-4474-a663-dfe7e91ac3202025-12-30WarningsExact identifier
application number: M007
MILK OF MAGNESIAMAGNESIUM HYDROXIDERUGBY LABORATORIESb1bafa6e-0f54-1c35-e053-2995a90a42e42025-12-30WarningsExact identifier
application number: M007
OneLAX SENNASENNAATLANTIC BIOLOGICALS CORP.d2a5a13a-e7e4-488a-b60b-4dd467efa9712025-12-29WarningsExact identifier
application number: M007
Senna SyrupSENNOSIDESLlorens Pharmaceutical International Division, Inc.5be0163c-b7f7-46db-b738-78c2946a6cf62025-12-29WarningsExact identifier
application number: M007
SenokotSTANDARDIZED SENNA CONCENTRATEAtlantis Consumer Healthcare, Inc.c18dd7fa-993b-440b-8cdd-f1551abb99ca2025-12-29WarningsExact identifier
application number: M007
LAXATIVEBISACODYLGRAXCELL PHARMACEUTICAL, LLC5a65d4ab-447f-42bb-b38d-070db523b8062025-12-25WarningsExact identifier
application number: M007
Senna-SSENNOSIDES 8.6MG AND DOCUSATE SODIUM 50MGPharbest Pharmaceuticals, Inc.2b5152b2-d354-409f-a19f-b470f4181b3f2025-12-24WarningsExact identifier
application number: M007
Senna TabsSENNAPharbest Pharmaceuticals, Inc.b9f8ea59-932f-4827-a87c-b4aff909c43f2025-12-24WarningsExact identifier
application number: M007
Senna PlusDOCUSATE SODIUM 50 MG AND SENNOSIDES 8.6 MGCARDINAL HEALTH, 110 DBA LEADER4d4101ca-7d78-4712-9b3d-f395f2646c6b2025-12-23WarningsExact identifier
application number: M007
Equate Gentle Laxative Soft chewMAGNESIUM HYDROXIDEWalmart0997c1b7-16db-7db7-e063-6294a90a59282025-12-23WarningsExact identifier
application number: M007
Equate Kids Gentle Laxative SCMAGNESIUM HYDROXIDEWalmart1662a542-aef0-9087-e063-6294a90aa6d92025-12-23WarningsExact identifier
application number: M007
AMAZON FIBER CAPLETSCALCIUM POLYCARBOPHILAMAZON.COM SERVICES LLC178f4150-c75c-45e1-a5f3-3af67b5c81092025-12-22WarningsExact identifier
application number: M007
AMAZON FIBER THERAPYMETHYLCELLULOSEAMAZON.COM SERVICES LLC3eee7b21-5401-4ef1-b1c6-1013439639d22025-12-22WarningsExact identifier
application number: M007
SennosidesSENNOSIDESGranules USA Inca619b8f4-1b5d-181b-e053-2995a90ab7292025-12-22WarningsExact identifier
application number: M007
CAREALL SennosidesSENNOSIDESNew World Imports, Inc61bbbb6a-9997-4df1-94be-a80686d1f1b92025-12-22WarningsExact identifier
application number: M007
Walgreens Blueberry Raspberry Gentle LaxativeMAGNESIUM HYDROXIDEWalgreend35f1518-bc63-83eb-e053-2995a90ae4bb2025-12-21WarningsExact identifier
application number: M007
SennosidesSENNOSIDESWalgreens Co85a2f7ed-315e-2403-e053-2991aa0abdce2025-12-19WarningsExact identifier
application number: M007
SennosidesSENNOSIDESH E Ba5652d5b-43fd-5bfa-e053-2995a90aad6c2025-12-19WarningsExact identifier
application number: M007

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1115005docusate sodium 100 MG Oral CapsulePSN92df761b-da68-4ce9-b02a-a5a74fd6620e8
1115005docusate sodium 100 MG Oral CapsuleSCD92df761b-da68-4ce9-b02a-a5a74fd6620e8
1115005DOSS Sodium 100 MG Oral CapsuleSY92df761b-da68-4ce9-b02a-a5a74fd6620e8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0363-4100-2000363410020200 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (0363-4100-20) 2020-12-310000-00-00NoNoCurrent
0363-4100-4000363410040400 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (0363-4100-40) 2020-12-310000-00-00NoNoCurrent
0363-4100-60003634100601 BOTTLE, PLASTIC in 1 BOX (0363-4100-60) / 60 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC2020-12-310000-00-00NoNoCurrent