FDA.reportPublic FDA data

Stool Softener

Product NDC
62011-0474
11-digit product format
620110474
Labeler code
62011
Product ID
62011-0474_f0403ba2-8fe3-4474-be18-d971227c0e51
Type
HUMAN OTC DRUG
Nonproprietary name
Docusate Sodium
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
Strategic Sourcing Services LLC
Application
part334
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2021-06-25
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct62011-0474DDiscontinued by firm2026-10-12
excluded packagepackage62011-047462011-0474-1DDiscontinued by firm2026-10-12

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 · 4 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage62011-0474-1d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage62011-0474-1f5e01cc5f278…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
62011-0474-1EA - Each62011-0474b449543c-2066-4104-90cf-f3de569d9b3512021-11-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62011-0474STOOL SOFTENER EXTRA STRENGTH (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [STRATEGIC SOURCING SERVICES LLC]3Legacy NDC20240531_cb92de8b-1e52-406c-ba38-3de1cd809d0a.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
62011-0474-162011047401100 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (62011-0474-1) 2021-06-250000-00-00NoNoCurrent