Docusate Sodium

Product NDC
11788-015
11-digit product format
117880015
Labeler code
11788
Product ID
11788-015_971926b7-14f3-623b-e053-2a95a90a0e4a
Type
HUMAN OTC DRUG
Nonproprietary name
Docusate Sodium
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
AiPing Pharmaceutical, Inc.
Application
part334
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2018-11-01
Marketing end
0000-00-00
Substance
DOCUSATE SODIUM
Active strength
100 mg/1
NDC exclude flag
No
Listing certified through
2020-12-31
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 productproduct11788-015DDiscontinued by firm2026-10-05
excluded productproduct11788-015DDiscontinued by firm2026-10-05
excluded packagepackage11788-01511788-015-00DDiscontinued by firm2026-10-05
excluded packagepackage11788-01511788-015-01DDiscontinued 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 · 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 productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage11788-015-00d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage11788-015-01d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage11788-015-00f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage11788-015-01f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage11788-015-002ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage11788-015-012ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage11788-015-00a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage11788-015-01a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage11788-015-00cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage11788-015-01cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage11788-015-00cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage11788-015-01cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage11788-015-00302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage11788-015-01302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage11788-015-00ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage11788-015-01ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage11788-015-000efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage11788-015-010efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage11788-015-00ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage11788-015-01ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage11788-015-00367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage11788-015-01367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage11788-015-00557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage11788-015-01557ba5c1ecfa…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 INGREDIENTF05Q2T2JA0DOCUSATE SODIUM (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [AIPING PHARMACEUTICAL, INC.]1
DOCUSATEACTIVE MOIETYM7P27195AGDOCUSATE SODIUM (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [AIPING PHARMACEUTICAL, INC.]1
D&C RED NO. 33INACTIVE INGREDIENT9DBA0SBB0LDOCUSATE SODIUM (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [AIPING PHARMACEUTICAL, INC.]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOADOCUSATE SODIUM (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [AIPING PHARMACEUTICAL, INC.]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8DOCUSATE SODIUM (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [AIPING PHARMACEUTICAL, INC.]1
GELATININACTIVE INGREDIENT2G86QN327LDOCUSATE SODIUM (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [AIPING PHARMACEUTICAL, INC.]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXDOCUSATE SODIUM (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [AIPING PHARMACEUTICAL, INC.]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ADOCUSATE SODIUM (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [AIPING PHARMACEUTICAL, INC.]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3DOCUSATE SODIUM (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [AIPING PHARMACEUTICAL, INC.]1
SORBITOLINACTIVE INGREDIENT506T60A25RDOCUSATE SODIUM (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [AIPING PHARMACEUTICAL, INC.]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPDOCUSATE SODIUM (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [AIPING PHARMACEUTICAL, INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RDOCUSATE SODIUM (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [AIPING PHARMACEUTICAL, INC.]1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
11788-015-00117880015001 BAG in 1 BOX (11788-015-00) > 19000 CAPSULE, LIQUID FILLED in 1 BAG1 bag2018-11-010000-00-00NoNoCurrent
11788-015-0111788001501100 CAPSULE, LIQUID FILLED in 1 BOTTLE (11788-015-01) 2018-11-010000-00-00NoNoCurrent