FDA.reportPublic FDA data

Stool Softener Laxative

Product NDC
62011-0421
Requested package NDC
62011-0421-2
11-digit product format
620110421
Labeler code
62011
Product ID
62011-0421_6afd3d8e-3e0d-4b25-aa60-cfdc63346611
Type
HUMAN OTC DRUG
Nonproprietary name
DOCUSATE SODIUM
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
Strategic Sourcing Services LLC
Application
part334
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2021-01-29
Marketing end
0000-00-00
Substance
DOCUSATE SODIUM
Active strength
100 mg/1
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage62011-042162011-0421-2DDiscontinued by firm2026-10-20

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62011-0421-1Stool Softener Laxative100 in 1 BOTTLE, PLASTICCAPSULE, LIQUID FILLED1004
62011-0421-2Stool Softener Laxative250 in 1 BOTTLE, PLASTICCAPSULE, LIQUID FILLED2504

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62011-0421-1EA - Each62011-04219145438d-2421-46bf-85be-2deba18f770112023-02-06
62011-0421-2EA - Each62011-042160af18c3-ac01-433f-8ef7-241b0604ee1712021-12-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62011-0421STOOL SOFTENER LAXATIVE (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [STRATEGIC SOURCING SERVICES LLC]4Legacy NDC, 2 package rows20240530_356dad05-c1c2-44d5-84f1-06e9e8f1de6b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1115005docusate sodium 100 MG Oral CapsulePSN356dad05-c1c2-44d5-84f1-06e9e8f1de6b4
1115005docusate sodium 100 MG Oral CapsuleSCD356dad05-c1c2-44d5-84f1-06e9e8f1de6b4
1115005DOSS Sodium 100 MG Oral CapsuleSY356dad05-c1c2-44d5-84f1-06e9e8f1de6b4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
62011-0421-262011042102250 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (62011-0421-2) 2021-01-290000-00-00NoNoCurrent