FDA.reportPublic FDA data

Docusate Sodium

Product NDC
0904-6998
Requested package NDC
0904-6998-80
11-digit product format
009046998
Labeler code
0904
Product ID
0904-6998_ce4db2ad-d866-4bed-a1b1-2c2491a0b34d
Type
HUMAN OTC DRUG
Nonproprietary name
DOCUSATE SODIUM
Dosage form
CAPSULE
Route
ORAL
Labeler
Major Pharmaceuticals
Application
part334
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2020-02-28
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 packagepackage0904-69980904-6998-80DDiscontinued 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 · 1 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 packagepackage0904-69980904-6998-80DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…

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
0904-6998-60EA - Each0904-6998d821c784-9742-4476-8dfb-c2f1c92a60eb12021-03-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0904-6998DOCUSATE SODIUM CAPSULE [MAJOR PHARMACEUTICALS]6Legacy NDC20240413_eb5e036b-dc1c-4a8d-b2c6-de1395384c57.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1115005docusate sodium 100 MG Oral CapsulePSN5999904a-6ac8-4d9e-951c-6e64e8cd93eb3
1115005docusate sodium 100 MG Oral CapsuleSCD5999904a-6ac8-4d9e-951c-6e64e8cd93eb3
1115005DOSS Sodium 100 MG Oral CapsuleSY5999904a-6ac8-4d9e-951c-6e64e8cd93eb3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0904-6998-80009046998801000 CAPSULE in 1 BOTTLE, PLASTIC (0904-6998-80) 1000 capsule2020-02-280000-00-00NoNoCurrent