Stool Softener

Product NDC
63941-238
11-digit product format
639410238
Labeler code
63941
Product ID
63941-238_b07ad416-c47b-4aa6-8720-77fb52628a06
Type
HUMAN OTC DRUG
Nonproprietary name
DOCUSATE SODIUM
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
Best Choice (Valu Merchandisers Company)
Application
part334
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2013-07-30
Marketing end
2020-12-31
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 productproduct63941-238DDiscontinued by firm2026-10-16
excluded packagepackage63941-23863941-238-10DDiscontinued by firm2026-10-16

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 packagepackage63941-238-10d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage63941-238-10f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage63941-238-102ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage63941-238-10a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage63941-238-10cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage63941-238-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage63941-238-10302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage63941-238-10ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage63941-238-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage63941-238-10ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage63941-238-10367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage63941-238-10557ba5c1ecfa…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 [BEST CHOICE (VALU MERCHANDISERS COMPANY)]2
DOCUSATEACTIVE MOIETYM7P27195AGSTOOL SOFTENER (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [BEST CHOICE (VALU MERCHANDISERS COMPANY)]2
D&C RED NO. 33INACTIVE INGREDIENT9DBA0SBB0LSTOOL SOFTENER (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [BEST CHOICE (VALU MERCHANDISERS COMPANY)]2
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GSTOOL SOFTENER (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [BEST CHOICE (VALU MERCHANDISERS COMPANY)]2
EGG PHOSPHOLIPIDSINACTIVE INGREDIENT1Z74184RGVSTOOL SOFTENER (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [BEST CHOICE (VALU MERCHANDISERS COMPANY)]2
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDSTOOL SOFTENER (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [BEST CHOICE (VALU MERCHANDISERS COMPANY)]2
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOASTOOL SOFTENER (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [BEST CHOICE (VALU MERCHANDISERS COMPANY)]2
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8STOOL SOFTENER (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [BEST CHOICE (VALU MERCHANDISERS COMPANY)]2
GELATININACTIVE INGREDIENT2G86QN327LSTOOL SOFTENER (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [BEST CHOICE (VALU MERCHANDISERS COMPANY)]2
GLYCERININACTIVE INGREDIENTPDC6A3C0OXSTOOL SOFTENER (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [BEST CHOICE (VALU MERCHANDISERS COMPANY)]2
MEDIUM-CHAIN TRIGLYCERIDESINACTIVE INGREDIENTC9H2L21V7USTOOL SOFTENER (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [BEST CHOICE (VALU MERCHANDISERS COMPANY)]2
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ASTOOL SOFTENER (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [BEST CHOICE (VALU MERCHANDISERS COMPANY)]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3STOOL SOFTENER (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [BEST CHOICE (VALU MERCHANDISERS COMPANY)]2
SORBITANINACTIVE INGREDIENT6O92ICV9RUSTOOL SOFTENER (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [BEST CHOICE (VALU MERCHANDISERS COMPANY)]2
SORBITOLINACTIVE INGREDIENT506T60A25RSTOOL SOFTENER (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [BEST CHOICE (VALU MERCHANDISERS COMPANY)]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPSTOOL SOFTENER (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [BEST CHOICE (VALU MERCHANDISERS COMPANY)]2
WATERINACTIVE INGREDIENT059QF0KO0RSTOOL SOFTENER (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [BEST CHOICE (VALU MERCHANDISERS COMPANY)]2