FDA.reportPublic FDA data

DOCUSATE SODIUM

Product NDC
68210-4104
Requested package NDC
68210-4104-0
11-digit product format
682104104
Labeler code
68210
Product ID
68210-4104_eeca812d-b15c-1e04-e053-2a95a90a274f
Type
HUMAN OTC DRUG
Nonproprietary name
DOCUSATE SODIUM
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
Spirit Pharmaceuticals LLC
Application
part334
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2020-07-02
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 packagepackage68210-410468210-4104-0IInactivated by FDA2026-10-21

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
68210-4104-02026-01-29C16284748780-149896155-c496-586f-e063-e6dba90add90Docusate Sodium 100mg
68210-4104-12026-01-29C16284748780-149896155-c496-586f-e063-e6dba90add90Docusate Sodium 100mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68210-4104-0DOCUSATE SODIUM100 in 1 BOTTLECAPSULE, LIQUID FILLED1007
68210-4104-1DOCUSATE SODIUM75 in 1 PACKAGECAPSULE, LIQUID FILLED757

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68210-4104DOCUSATE SODIUM CAPSULE, LIQUID FILLED [SPIRIT PHARMACEUTICALS LLC]7Legacy NDC, 2 package rows20241215_31e711c1-24a0-4b57-9f03-3fc22c6bcba0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1115005docusate sodium 100 MG Oral CapsulePSN31e711c1-24a0-4b57-9f03-3fc22c6bcba07
1115005docusate sodium 100 MG Oral CapsuleSCD31e711c1-24a0-4b57-9f03-3fc22c6bcba07
1115005DOSS Sodium 100 MG Oral CapsuleSY31e711c1-24a0-4b57-9f03-3fc22c6bcba07

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68210-4104-068210410400100 CAPSULE, LIQUID FILLED in 1 BOTTLE (68210-4104-0) 2020-07-020000-00-00NoNoCurrent