FDA.reportPublic FDA data

STOOL SOFTENER

Product NDC
51013-122
Requested package NDC
51013-122-27
11-digit product format
510130122
Labeler code
51013
Product ID
51013-122_c4d21f2c-548f-44fe-b015-723210781f0f
Type
HUMAN OTC DRUG
Nonproprietary name
DOCUSATE SODIUM
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
PuraCap Pharmaceutical LLC
Application
part334
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2016-06-01
Marketing end
0000-00-00
Substance
DOCUSATE SODIUM
Active strength
100 mg/1
NDC exclude flag
No
Listing certified through
2020-12-31
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 packagepackage51013-12251013-122-27IInactivated by FDA2026-10-12

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 · 9 matching rows.

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

Captured / source date, Code, Status table
Captured / source dateCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31UExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20UExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10UExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…

Reported adverse events (FAERS/openFDA)#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
51013-122-242025-01-30C16284748780-12cef2736-b05d-d83d-e063-dadaa90ab31fSTOOL SOFTENER
51013-122-272025-01-30C16284748780-12cef2736-a87d-d83d-e063-dadaa90ab31fSTOOL SOFTENER

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51013-122-24STOOL SOFTENER100 in 1 BOTTLECAPSULE, LIQUID FILLED1002
51013-122-24STOOL SOFTENER1 in 1 CARTONCAPSULE, LIQUID FILLED12
51013-122-27STOOL SOFTENER250 in 1 BOTTLECAPSULE, LIQUID FILLED2502

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51013-122STOOL SOFTENER (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [PURACAP PHARMACEUTICAL LLC]2Legacy NDC, 2 package rows20191212_9b7c4aba-4a2a-4a9a-bf77-a7eca9675800.zip
51013-122STOOL SOFTENER (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [PURACAP PHARMACEUTICAL LLC]2Legacy NDC, 1 package rows20191212_ae7eea3e-ab7c-457b-8fb1-07ca2133851d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1115005docusate sodium 100 MG Oral CapsulePSN9b7c4aba-4a2a-4a9a-bf77-a7eca96758002
1115005docusate sodium 100 MG Oral CapsulePSNae7eea3e-ab7c-457b-8fb1-07ca2133851d2
1115005docusate sodium 100 MG Oral CapsuleSCD9b7c4aba-4a2a-4a9a-bf77-a7eca96758002
1115005docusate sodium 100 MG Oral CapsuleSCDae7eea3e-ab7c-457b-8fb1-07ca2133851d2
1115005DOSS Sodium 100 MG Oral CapsuleSY9b7c4aba-4a2a-4a9a-bf77-a7eca96758002
1115005DOSS Sodium 100 MG Oral CapsuleSYae7eea3e-ab7c-457b-8fb1-07ca2133851d2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
51013-122-2751013012227250 CAPSULE, LIQUID FILLED in 1 BOTTLE (51013-122-27) 2016-06-300000-00-00NoNoCurrent