FDA.reportPublic FDA data

Stool Softener Laxative

Product NDC
68196-578
11-digit product format
681960578
Labeler code
68196
Product ID
68196-578_2bcb86a6-2941-4749-b4bd-612752793458
Type
HUMAN OTC DRUG
Nonproprietary name
DOCUSATE SODIUM
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
Sam's West, Inc
Application
part334
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2018-09-30
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct68196-578DDiscontinued by firm2026-10-16
excluded packagepackage68196-57868196-578-60DDiscontinued by firm2026-10-16

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
68196-578-602023-05-09C16284748780-1f386c649-daa8-0266-e053-dadaa90a7c1aDrug Facts
68196-578-602023-01-30C16284748780-1f386c649-daa8-0266-e053-dadaa90a7c1aDrug Facts

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68196-578-60EA - Each68196-5781add61b1-673c-49cf-8bdb-bc364eb29af912024-04-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68196-578STOOL SOFTENER LAXATIVE (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [SAM'S WEST, INC]4Legacy NDC20240517_e1e1f551-b542-4cc0-b2f8-d2f663180eb6.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68196-578-6068196057860600 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (68196-578-60) 2018-09-300000-00-00NoNoCurrent