Stool Softener

Product NDC
55319-238
11-digit product format
553190238
Labeler code
55319
Product ID
55319-238_9fb43b8e-c48d-454e-bf6e-ce8f881478e7
Type
HUMAN OTC DRUG
Nonproprietary name
DOCUSATE SODIUM
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
Family Dollar (FAMILY WELLNESS)
Application
part334
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2013-08-30
Marketing end
2021-12-30
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct55319-238DDiscontinued by firm2026-10-12
excluded packagepackage55319-23855319-238-01DDiscontinued 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 · 24 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 packagepackage55319-238-01d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage55319-238-01f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage55319-238-012ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage55319-238-01a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage55319-238-01cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage55319-238-01cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage55319-238-01302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage55319-238-01ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage55319-238-010efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage55319-238-01ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage55319-238-01367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage55319-238-01557ba5c1ecfa…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 [FAMILY DOLLAR (FAMILY WELLNESS)]1
DOCUSATEACTIVE MOIETYM7P27195AGSTOOL SOFTENER (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [FAMILY DOLLAR (FAMILY WELLNESS)]1
D&C RED NO. 33INACTIVE INGREDIENT9DBA0SBB0LSTOOL SOFTENER (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [FAMILY DOLLAR (FAMILY WELLNESS)]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GSTOOL SOFTENER (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [FAMILY DOLLAR (FAMILY WELLNESS)]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDSTOOL SOFTENER (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [FAMILY DOLLAR (FAMILY WELLNESS)]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOASTOOL SOFTENER (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [FAMILY DOLLAR (FAMILY WELLNESS)]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8STOOL SOFTENER (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [FAMILY DOLLAR (FAMILY WELLNESS)]1
GELATININACTIVE INGREDIENT2G86QN327LSTOOL SOFTENER (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [FAMILY DOLLAR (FAMILY WELLNESS)]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXSTOOL SOFTENER (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [FAMILY DOLLAR (FAMILY WELLNESS)]1
LECITHIN, SOYBEANINACTIVE INGREDIENT1DI56QDM62STOOL SOFTENER (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [FAMILY DOLLAR (FAMILY WELLNESS)]1
MEDIUM-CHAIN TRIGLYCERIDESINACTIVE INGREDIENTC9H2L21V7USTOOL SOFTENER (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [FAMILY DOLLAR (FAMILY WELLNESS)]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ASTOOL SOFTENER (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [FAMILY DOLLAR (FAMILY WELLNESS)]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3STOOL SOFTENER (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [FAMILY DOLLAR (FAMILY WELLNESS)]1
SORBITANINACTIVE INGREDIENT6O92ICV9RUSTOOL SOFTENER (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [FAMILY DOLLAR (FAMILY WELLNESS)]1
SORBITOLINACTIVE INGREDIENT506T60A25RSTOOL SOFTENER (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [FAMILY DOLLAR (FAMILY WELLNESS)]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPSTOOL SOFTENER (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [FAMILY DOLLAR (FAMILY WELLNESS)]1
WATERINACTIVE INGREDIENT059QF0KO0RSTOOL SOFTENER (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [FAMILY DOLLAR (FAMILY WELLNESS)]1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
55319-238-0155319023801100 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (55319-238-01) 2013-08-302021-12-30NoNoCurrent