FDA.reportPublic FDA data

Docusate Sodium

Product NDC
55154-4341
11-digit product format
551544341
Labeler code
55154
Product ID
55154-4341_0e5d7b43-2893-42aa-ba5c-23155c15a2ee
Type
HUMAN OTC DRUG
Nonproprietary name
Docusate Sodium
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
Cardinal Health 107, LLC
Application
part334
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2017-05-17
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct55154-4341DDiscontinued by firm2026-10-12
excluded packagepackage55154-434155154-4341-0DDiscontinued by firm2026-10-12

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
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
55154-4341-02021-08-27C16284748780-1ba0f9c33-1c22-a910-e053-dadaa90a0b85Docusate Sodium, USP Stool Softener
55154-4341-02021-01-29C16284748780-1ba0f9c33-1c22-a910-e053-dadaa90a0b85Docusate Sodium, USP Stool Softener

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55154-4341-0Docusate Sodium1 in 1 BLISTER PACKCAPSULE, LIQUID FILLED17
55154-4341-0Docusate Sodium10 in 1 BAGCAPSULE, LIQUID FILLED107

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55154-4341DOCUSATE SODIUM CAPSULE, LIQUID FILLED [CARDINAL HEALTH 107, LLC]5Legacy NDC, 2 package rows20240716_2e92ab21-6e5f-4c85-85f9-931d2d573e05.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1245468docusate sodium 250 MG Oral CapsulePSN2e92ab21-6e5f-4c85-85f9-931d2d573e057
1245468docusate sodium 250 MG Oral CapsuleSCD2e92ab21-6e5f-4c85-85f9-931d2d573e057
1245468DOSS Sodium 250 MG Oral CapsuleSY2e92ab21-6e5f-4c85-85f9-931d2d573e057

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55154-4341-05515443410010 BLISTER PACK in 1 BAG (55154-4341-0) > 1 CAPSULE, LIQUID FILLED in 1 BLISTER PACK10 blister pack2017-05-170000-00-00NoNoCurrent