Stool Softener

Product NDC
61715-081
Requested package NDC
61715-081-51
11-digit product format
617150081
Labeler code
61715
Product ID
61715-081_c4848458-4f58-403a-b916-453d7de5dafa
Type
HUMAN OTC DRUG
Nonproprietary name
DOCUSATE SODIUM
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
Preferred Plus (Kinray)
Application
part334
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2013-09-30
Marketing end
2022-12-30
Substance
DOCUSATE SODIUM
Active strength
100 mg/1
NDC exclude flag
No
Listing certified through
0000-00-00
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 packagepackage61715-08161715-081-51DDiscontinued 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 · 12 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…

Reported adverse events (FAERS/openFDA)#

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

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DOCUSATE SODIUMACTIVE INGREDIENTF05Q2T2JA0STOOL SOFTENER (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [PREFERRED PLUS (KINRAY)]1
DOCUSATEACTIVE MOIETYM7P27195AGSTOOL SOFTENER (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [PREFERRED PLUS (KINRAY)]1
D&C RED NO. 33INACTIVE INGREDIENT9DBA0SBB0LSTOOL SOFTENER (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [PREFERRED PLUS (KINRAY)]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GSTOOL SOFTENER (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [PREFERRED PLUS (KINRAY)]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDSTOOL SOFTENER (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [PREFERRED PLUS (KINRAY)]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOASTOOL SOFTENER (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [PREFERRED PLUS (KINRAY)]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8STOOL SOFTENER (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [PREFERRED PLUS (KINRAY)]1
GELATININACTIVE INGREDIENT2G86QN327LSTOOL SOFTENER (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [PREFERRED PLUS (KINRAY)]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXSTOOL SOFTENER (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [PREFERRED PLUS (KINRAY)]1
LECITHIN, SOYBEANINACTIVE INGREDIENT1DI56QDM62STOOL SOFTENER (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [PREFERRED PLUS (KINRAY)]1
MEDIUM-CHAIN TRIGLYCERIDESINACTIVE INGREDIENTC9H2L21V7USTOOL SOFTENER (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [PREFERRED PLUS (KINRAY)]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ASTOOL SOFTENER (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [PREFERRED PLUS (KINRAY)]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3STOOL SOFTENER (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [PREFERRED PLUS (KINRAY)]1
SORBITANINACTIVE INGREDIENT6O92ICV9RUSTOOL SOFTENER (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [PREFERRED PLUS (KINRAY)]1
SORBITOLINACTIVE INGREDIENT506T60A25RSTOOL SOFTENER (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [PREFERRED PLUS (KINRAY)]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPSTOOL SOFTENER (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [PREFERRED PLUS (KINRAY)]1
WATERINACTIVE INGREDIENT059QF0KO0RSTOOL SOFTENER (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [PREFERRED PLUS (KINRAY)]1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
61715-081-5161715008151100 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (61715-081-51) 2013-09-302022-12-30NoNoCurrent