FDA.reportPublic FDA data

Stool Softener

Product NDC
0904-6999
Requested package NDC
0904-6999-80
11-digit product format
009046999
Labeler code
0904
Product ID
0904-6999_d843827d-caa0-4b07-8436-1f20da9d847a
Type
HUMAN OTC DRUG
Nonproprietary name
DOCUSATE SODIUM
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
Major Pharmaceuticals
Application
part334
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2019-09-30
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 packagepackage0904-69990904-6999-80DDiscontinued by firm2026-10-05

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 2 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0904-69990904-6999-80DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0904-69990904-6999-80DDiscontinued by firmexcluded / ndc_excluded.zipf5e01cc5f278…a2eaf40c39c3…

Reported adverse events (FAERS/openFDA)#

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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-6999-60EA - Each0904-6999fd084d32-1fa4-4246-a4b9-4ae829313b9512020-05-08
0904-6999-80EA - Each0904-699923352dc4-3f67-491a-a95d-5624167752bc12020-06-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0904-6999STOOL SOFTENER (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [MAJOR PHARMACEUTICALS]4Legacy NDC20240413_07aebb88-d790-4fff-adf0-a1c27a905526.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1245468docusate sodium 250 MG Oral CapsulePSNc16c273e-add4-4783-8b68-267721a744ef3
1245468docusate sodium 250 MG Oral CapsuleSCDc16c273e-add4-4783-8b68-267721a744ef3
1245468DOSS Sodium 250 MG Oral CapsuleSYc16c273e-add4-4783-8b68-267721a744ef3
1245468docusate sodium 250 MG Oral CapsulePSNd88e4a9c-bc3d-220f-e053-2a95a90a3a512
1245468docusate sodium 250 MG Oral CapsuleSCDd88e4a9c-bc3d-220f-e053-2a95a90a3a512
1245468DOSS Sodium 250 MG Oral CapsuleSYd88e4a9c-bc3d-220f-e053-2a95a90a3a512

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0904-6999-80009046999801000 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (0904-6999-80) 2019-09-300000-00-00NoNoCurrent