Stool Softener

Product NDC
41520-244
11-digit product format
415200244
Labeler code
41520
Product ID
41520-244_34a24fac-7344-4072-b7f9-e5ad555b484f
Type
HUMAN OTC DRUG
Nonproprietary name
DOCUSATE SODIUM
Dosage form
CAPSULE
Route
ORAL
Labeler
Care One (American Sales Company)
Application
part334
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2013-12-30
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 productproduct41520-244DDiscontinued by firm2026-10-15
excluded packagepackage41520-24441520-244-25DDiscontinued by firm2026-10-15

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 packagepackage41520-244-25d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage41520-244-25f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage41520-244-252ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage41520-244-25a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage41520-244-25cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage41520-244-25cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage41520-244-25302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage41520-244-25ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage41520-244-250efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage41520-244-25ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage41520-244-25367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage41520-244-25557ba5c1ecfa…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 GENTLE RELIEF (DOCUSATE SODIUM) CAPSULE [CARE ONE (AMERICAN SALES COMPANY)]1
DOCUSATEACTIVE MOIETYM7P27195AGSTOOL SOFTENER GENTLE RELIEF (DOCUSATE SODIUM) CAPSULE [CARE ONE (AMERICAN SALES COMPANY)]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOASTOOL SOFTENER GENTLE RELIEF (DOCUSATE SODIUM) CAPSULE [CARE ONE (AMERICAN SALES COMPANY)]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8STOOL SOFTENER GENTLE RELIEF (DOCUSATE SODIUM) CAPSULE [CARE ONE (AMERICAN SALES COMPANY)]1
GELATININACTIVE INGREDIENT2G86QN327LSTOOL SOFTENER GENTLE RELIEF (DOCUSATE SODIUM) CAPSULE [CARE ONE (AMERICAN SALES COMPANY)]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXSTOOL SOFTENER GENTLE RELIEF (DOCUSATE SODIUM) CAPSULE [CARE ONE (AMERICAN SALES COMPANY)]1
MEDIUM-CHAIN TRIGLYCERIDESINACTIVE INGREDIENTC9H2L21V7USTOOL SOFTENER GENTLE RELIEF (DOCUSATE SODIUM) CAPSULE [CARE ONE (AMERICAN SALES COMPANY)]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ASTOOL SOFTENER GENTLE RELIEF (DOCUSATE SODIUM) CAPSULE [CARE ONE (AMERICAN SALES COMPANY)]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3STOOL SOFTENER GENTLE RELIEF (DOCUSATE SODIUM) CAPSULE [CARE ONE (AMERICAN SALES COMPANY)]1
SORBITANINACTIVE INGREDIENT6O92ICV9RUSTOOL SOFTENER GENTLE RELIEF (DOCUSATE SODIUM) CAPSULE [CARE ONE (AMERICAN SALES COMPANY)]1
SORBITOLINACTIVE INGREDIENT506T60A25RSTOOL SOFTENER GENTLE RELIEF (DOCUSATE SODIUM) CAPSULE [CARE ONE (AMERICAN SALES COMPANY)]1
WATERINACTIVE INGREDIENT059QF0KO0RSTOOL SOFTENER GENTLE RELIEF (DOCUSATE SODIUM) CAPSULE [CARE ONE (AMERICAN SALES COMPANY)]1