FDA.reportPublic FDA data

DOCUSATE SODIUM

Product NDC
55910-223
Requested package NDC
55910-223-10
11-digit product format
559100223
Labeler code
55910
Product ID
55910-223_edc5f623-9c95-0e7f-e053-2a95a90aec94
Type
HUMAN OTC DRUG
Nonproprietary name
DOCUSATE SODIUM
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
Dolgencorp, Inc.
Application
part334
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2019-05-21
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 packagepackage55910-22355910-223-10IInactivated by FDA2026-10-05

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55910-223-10DOCUSATE SODIUM1 in 1 CARTONCAPSULE, LIQUID FILLED16
55910-223-10DOCUSATE SODIUM100 in 1 BOTTLECAPSULE, LIQUID FILLED1006

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55910-223DOCUSATE SODIUM CAPSULE, LIQUID FILLED [DOLGENCORP, INC.]6Legacy NDC, 2 package rows20241222_2b29df80-b142-474b-8139-fbfd456ae09d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1115005docusate sodium 100 MG Oral CapsulePSN2b29df80-b142-474b-8139-fbfd456ae09d6
1115005docusate sodium 100 MG Oral CapsuleSCD2b29df80-b142-474b-8139-fbfd456ae09d6
1115005DOSS Sodium 100 MG Oral CapsuleSY2b29df80-b142-474b-8139-fbfd456ae09d6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55910-223-10559100223101 BOTTLE in 1 CARTON (55910-223-10) > 100 CAPSULE, LIQUID FILLED in 1 BOTTLE1 bottle2019-05-210000-00-00NoNoCurrent