FDA.reportPublic FDA data

Stool Softener

Product NDC
0363-0238
11-digit product format
003630238
Labeler code
0363
Product ID
0363-0238_910e5c73-4c2e-4d00-ac06-d3fa888fc986
Type
HUMAN OTC DRUG
Nonproprietary name
DOCUSATE SODIUM
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
Walgreens
Application
part334
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2013-09-30
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 · 4 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct0363-0238DDiscontinued by firm2026-08-11
excluded packagepackage0363-02380363-0238-06DDiscontinued by firm2026-08-11
excluded packagepackage0363-02380363-0238-20DDiscontinued by firm2026-08-11
excluded packagepackage0363-02380363-0238-40DDiscontinued by firm2026-08-11

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 · 48 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 packagepackage0363-0238-20d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0363-0238-40d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0363-0238-06d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0363-0238-20f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0363-0238-40f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0363-0238-06f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0363-0238-202ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0363-0238-402ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0363-0238-062ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0363-0238-20a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0363-0238-40a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0363-0238-06a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0363-0238-20cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0363-0238-40cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0363-0238-06cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0363-0238-20cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0363-0238-40cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0363-0238-06cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0363-0238-20302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0363-0238-40302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0363-0238-06302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0363-0238-20ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0363-0238-40ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0363-0238-06ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0363-0238-200efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0363-0238-400efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0363-0238-060efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0363-0238-20ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0363-0238-40ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0363-0238-06ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0363-0238-20367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0363-0238-40367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0363-0238-06367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0363-0238-20557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0363-0238-40557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0363-0238-06557ba5c1ecfa…9c80585c8c6e…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0363-0238-06EA - Each0363-02382fa7db03-a73b-4995-b543-7ff299ea058612014-10-03
0363-0238-20EA - Each0363-023828d77084-c57a-4726-b38f-332078271b8412014-10-03
0363-0238-40EA - Each0363-0238095931d0-ec7c-49f4-abce-6713a6e6c53c12014-10-03

DailyMed Socrata Ingredients#

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0363-0238-06003630238061 BOTTLE, PLASTIC in 1 BOX (0363-0238-06) > 60 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC2013-09-302021-12-30NoNoCurrent
0363-0238-2000363023820200 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (0363-0238-20) 2013-09-302021-12-30NoNoCurrent
0363-0238-4000363023840400 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (0363-0238-40) 2013-09-302021-12-30NoNoCurrent