Non-Habit Forming Stool Softener

Product NDC
0536-3756
11-digit product format
005363756
Labeler code
0536
Product ID
0536-3756_ae5432d1-86b6-455d-aef3-e3796ee5a285
Type
HUMAN OTC DRUG
Nonproprietary name
DOCUSATE SODIUM
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
Rugby Laboratories, Inc.
Application
part334
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2012-03-29
Marketing end
2019-12-31
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 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct0536-3756DDiscontinued by firm2026-08-11
excluded packagepackage0536-37560536-3756-01DDiscontinued by firm2026-08-11
excluded packagepackage0536-37560536-3756-10DDiscontinued 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 · 36 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 packagepackage0536-3756-01d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0536-3756-10d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0536-3756-01f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0536-3756-10f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0536-3756-012ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0536-3756-102ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0536-3756-01a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0536-3756-10a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0536-3756-01cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0536-3756-10cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0536-3756-01cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0536-3756-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0536-3756-01302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0536-3756-10302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0536-3756-01ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0536-3756-10ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0536-3756-010efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0536-3756-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0536-3756-01ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0536-3756-10ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0536-3756-01367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0536-3756-10367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0536-3756-01557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0536-3756-10557ba5c1ecfa…9c80585c8c6e…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0536-3756-01EA - Each0536-37568fd965ad-aad1-4339-b7a2-362c0a1f306112012-07-24
0536-3756-10EA - Each0536-37563791905f-77b1-4557-9988-9c77fa97f97612012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DOCUSATE SODIUMACTIVE INGREDIENTF05Q2T2JA0NON-HABIT FORMING STOOL SOFTENER (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [RUGBY LABORATORIES INC]4
DOCUSATEACTIVE MOIETYM7P27195AGNON-HABIT FORMING STOOL SOFTENER (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [RUGBY LABORATORIES INC]4
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOANON-HABIT FORMING STOOL SOFTENER (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [RUGBY LABORATORIES INC]4
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8NON-HABIT FORMING STOOL SOFTENER (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [RUGBY LABORATORIES INC]4
GELATININACTIVE INGREDIENT2G86QN327LNON-HABIT FORMING STOOL SOFTENER (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [RUGBY LABORATORIES INC]4
GLYCERININACTIVE INGREDIENTPDC6A3C0OXNON-HABIT FORMING STOOL SOFTENER (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [RUGBY LABORATORIES INC]4
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ANON-HABIT FORMING STOOL SOFTENER (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [RUGBY LABORATORIES INC]4
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3NON-HABIT FORMING STOOL SOFTENER (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [RUGBY LABORATORIES INC]4
SORBITOLINACTIVE INGREDIENT506T60A25RNON-HABIT FORMING STOOL SOFTENER (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [RUGBY LABORATORIES INC]4
WATERINACTIVE INGREDIENT059QF0KO0RNON-HABIT FORMING STOOL SOFTENER (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [RUGBY LABORATORIES INC]4
DOCUSATE SODIUMACTIVE INGREDIENTF05Q2T2JA0NON-HABIT FORMING STOOL SOFTENER (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [REBEL DISTRIBUTORS CORP]2
DOCUSATE SODIUMACTIVE INGREDIENTF05Q2T2JA0DOCUSATE SODIUM CAPSULE, LIQUID FILLED [DIRECT RX]2
DOCUSATEACTIVE MOIETYM7P27195AGNON-HABIT FORMING STOOL SOFTENER (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [REBEL DISTRIBUTORS CORP]2
DOCUSATEACTIVE MOIETYM7P27195AGDOCUSATE SODIUM CAPSULE, LIQUID FILLED [DIRECT RX]2
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOANON-HABIT FORMING STOOL SOFTENER (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [REBEL DISTRIBUTORS CORP]2
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOADOCUSATE SODIUM CAPSULE, LIQUID FILLED [DIRECT RX]2
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8DOCUSATE SODIUM CAPSULE, LIQUID FILLED [DIRECT RX]2
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8NON-HABIT FORMING STOOL SOFTENER (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [REBEL DISTRIBUTORS CORP]2
GELATININACTIVE INGREDIENT2G86QN327LDOCUSATE SODIUM CAPSULE, LIQUID FILLED [DIRECT RX]2
GELATININACTIVE INGREDIENT2G86QN327LNON-HABIT FORMING STOOL SOFTENER (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [REBEL DISTRIBUTORS CORP]2
GLYCERININACTIVE INGREDIENTPDC6A3C0OXDOCUSATE SODIUM CAPSULE, LIQUID FILLED [DIRECT RX]2
GLYCERININACTIVE INGREDIENTPDC6A3C0OXNON-HABIT FORMING STOOL SOFTENER (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [REBEL DISTRIBUTORS CORP]2
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ADOCUSATE SODIUM CAPSULE, LIQUID FILLED [DIRECT RX]2
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ANON-HABIT FORMING STOOL SOFTENER (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [REBEL DISTRIBUTORS CORP]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3DOCUSATE SODIUM CAPSULE, LIQUID FILLED [DIRECT RX]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3NON-HABIT FORMING STOOL SOFTENER (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [REBEL DISTRIBUTORS CORP]2
SORBITOLINACTIVE INGREDIENT506T60A25RNON-HABIT FORMING STOOL SOFTENER (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [REBEL DISTRIBUTORS CORP]2
SORBITOLINACTIVE INGREDIENT506T60A25RDOCUSATE SODIUM CAPSULE, LIQUID FILLED [DIRECT RX]2
WATERINACTIVE INGREDIENT059QF0KO0RNON-HABIT FORMING STOOL SOFTENER (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [REBEL DISTRIBUTORS CORP]2
WATERINACTIVE INGREDIENT059QF0KO0RDOCUSATE SODIUM CAPSULE, LIQUID FILLED [DIRECT RX]2
DOCUSATE SODIUMACTIVE INGREDIENTF05Q2T2JA0NON-HABIT FORMING STOOL SOFTENER (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [AIDAREX PHARMACEUTICALS LLC]1
DOCUSATEACTIVE MOIETYM7P27195AGNON-HABIT FORMING STOOL SOFTENER (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [AIDAREX PHARMACEUTICALS LLC]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOANON-HABIT FORMING STOOL SOFTENER (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [AIDAREX PHARMACEUTICALS LLC]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8NON-HABIT FORMING STOOL SOFTENER (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [AIDAREX PHARMACEUTICALS LLC]1
GELATININACTIVE INGREDIENT2G86QN327LNON-HABIT FORMING STOOL SOFTENER (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [AIDAREX PHARMACEUTICALS LLC]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXNON-HABIT FORMING STOOL SOFTENER (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [AIDAREX PHARMACEUTICALS LLC]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ANON-HABIT FORMING STOOL SOFTENER (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [AIDAREX PHARMACEUTICALS LLC]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3NON-HABIT FORMING STOOL SOFTENER (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [AIDAREX PHARMACEUTICALS LLC]1
SORBITOLINACTIVE INGREDIENT506T60A25RNON-HABIT FORMING STOOL SOFTENER (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [AIDAREX PHARMACEUTICALS LLC]1
WATERINACTIVE INGREDIENT059QF0KO0RNON-HABIT FORMING STOOL SOFTENER (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [AIDAREX PHARMACEUTICALS LLC]1

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1115005docusate sodium 100 MG Oral CapsulePSNc95063e2-e0fc-43a4-b084-e1be88055f802
1115005docusate sodium 100 MG Oral CapsulePSNce9f4623-e4b6-4ed3-9fb6-231d7f85bedc2
1115005docusate sodium 100 MG Oral CapsuleSCDc95063e2-e0fc-43a4-b084-e1be88055f802
1115005docusate sodium 100 MG Oral CapsuleSCDce9f4623-e4b6-4ed3-9fb6-231d7f85bedc2
1115005DOSS Sodium 100 MG Oral CapsuleSYc95063e2-e0fc-43a4-b084-e1be88055f802
1115005DOSS Sodium 100 MG Oral CapsuleSYce9f4623-e4b6-4ed3-9fb6-231d7f85bedc2
1115005docusate sodium 100 MG Oral CapsulePSNe6b1263b-a09e-4f4e-bcba-d0f67d6a9e241
1115005docusate sodium 100 MG Oral CapsuleSCDe6b1263b-a09e-4f4e-bcba-d0f67d6a9e241
1115005DOSS Sodium 100 MG Oral CapsuleSYe6b1263b-a09e-4f4e-bcba-d0f67d6a9e241