FDA.reportPublic FDA data

Stool Softener Laxative

Product NDC
36800-568
Requested package NDC
36800-568-10
11-digit product format
368000568
Labeler code
36800
Product ID
36800-568_411aab31-5836-4515-9732-68fb8278a3a0
Type
HUMAN OTC DRUG
Nonproprietary name
Docusate Sodium
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
TOP CARE (Topco Associates LLC)
Application
part334
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2019-11-29
Marketing end
0000-00-00
Substance
DOCUSATE SODIUM
Active strength
250 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 packagepackage36800-56836800-568-10DDiscontinued by firm2026-10-15

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
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
36800-568-10Stool Softener LaxativeExtra Strength100 in 1 BOTTLE, PLASTICCAPSULE, LIQUID FILLED1003

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
36800-568STOOL SOFTENER LAXATIVE EXTRA STRENGTH (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [TOP CARE (TOPCO ASSOCIATES LLC)]3Legacy NDC, 1 package rows20241115_3f81e49a-9a0c-48fd-a2a3-9e665493bace.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1245468docusate sodium 250 MG Oral CapsulePSN3f81e49a-9a0c-48fd-a2a3-9e665493bace3
1245468docusate sodium 250 MG Oral CapsuleSCD3f81e49a-9a0c-48fd-a2a3-9e665493bace3
1245468DOSS Sodium 250 MG Oral CapsuleSY3f81e49a-9a0c-48fd-a2a3-9e665493bace3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
36800-568-1036800056810100 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (36800-568-10) 2019-11-290000-00-00NoNoCurrent