Docusate Sodium

Product NDC
66424-030
11-digit product format
664240030
Labeler code
66424
Product ID
66424-030_c7bb68e7-5479-467d-9fc0-fdf5a459486a
Type
HUMAN OTC DRUG
Nonproprietary name
Docusate Sodium
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
SDA Laboratories, Inc.
Application
part334
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2010-09-15
Marketing end
0000-00-00
Substance
DOCUSATE SODIUM
Active strength
100 mg/1
NDC exclude flag
E
Listing certified through
2018-12-31
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 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct66424-030IInactivated by FDA2026-10-12
excluded packagepackage66424-03066424-030-01IInactivated by FDA2026-10-12
excluded packagepackage66424-03066424-030-10IInactivated by FDA2026-10-12

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 2 · 66 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 packagepackage66424-030-01d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage66424-030-10d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage66424-030-01f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage66424-030-10f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage66424-030-012ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage66424-030-102ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage66424-030-01a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage66424-030-10a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage66424-030-01cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage66424-030-10cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage66424-030-01cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage66424-030-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage66424-030-01302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage66424-030-10302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage66424-030-01ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage66424-030-10ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage66424-030-010efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage66424-030-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage66424-030-01ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage66424-030-10ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage66424-030-01367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage66424-030-10367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage66424-030-01557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage66424-030-10557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage66424-030-018af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage66424-030-108af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage66424-030-01834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage66424-030-10834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage66424-030-011332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage66424-030-101332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage66424-030-01fb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage66424-030-10fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage66424-030-0186f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage66424-030-1086f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage66424-030-01bd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage66424-030-10bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage66424-030-018dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage66424-030-108dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage66424-030-01e2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage66424-030-10e2bbac7714bc…27bdfed8d636…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
66424-030-012020-01-31C16284748780-19d75b9d0-3efe-f424-e053-dadaa90a57ceDrug Facts
66424-030-102020-01-31C16284748780-19d75b9d0-3efe-f424-e053-dadaa90a57ceDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66424-030-01Docusate Sodium100 in 1 BOTTLECAPSULE, LIQUID FILLED1001
66424-030-10Docusate Sodium1000 in 1 BOTTLECAPSULE, LIQUID FILLED10001

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
66424-030-01EA - Each66424-030954a6e36-bd1d-416b-ad9f-eb5b37afb75912013-11-04
66424-030-10EA - Each66424-03035c444f8-75d6-4228-b6b7-7aaf107e039b12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DOCUSATE SODIUMACTIVE INGREDIENTF05Q2T2JA0DOCUSATE SODIUM CAPSULE, LIQUID FILLED [BLENHEIM PHARMACAL, INC.]2
Docusate SodiumACTIVE INGREDIENTF05Q2T2JA0DOCUSATE SODIUM CAPSULE, LIQUID FILLED [UNIT DOSE SERVICES]2
DOCUSATEACTIVE MOIETYM7P27195AGDOCUSATE SODIUM CAPSULE, LIQUID FILLED [BLENHEIM PHARMACAL, INC.]2
DocusateACTIVE MOIETYM7P27195AGDOCUSATE SODIUM CAPSULE, LIQUID FILLED [UNIT DOSE SERVICES]2
D&C RED NO. 33INACTIVE INGREDIENT9DBA0SBB0LDOCUSATE SODIUM CAPSULE, LIQUID FILLED [BLENHEIM PHARMACAL, INC.]2
D&C RED NO. 33INACTIVE INGREDIENT9DBA0SBB0LDOCUSATE SODIUM CAPSULE, LIQUID FILLED [UNIT DOSE SERVICES]2
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOADOCUSATE SODIUM CAPSULE, LIQUID FILLED [BLENHEIM PHARMACAL, INC.]2
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOADOCUSATE SODIUM CAPSULE, LIQUID FILLED [UNIT DOSE SERVICES]2
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8DOCUSATE SODIUM CAPSULE, LIQUID FILLED [BLENHEIM PHARMACAL, INC.]2
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8DOCUSATE SODIUM CAPSULE, LIQUID FILLED [UNIT DOSE SERVICES]2
GELATININACTIVE INGREDIENT2G86QN327LDOCUSATE SODIUM CAPSULE, LIQUID FILLED [UNIT DOSE SERVICES]2
GELATININACTIVE INGREDIENT2G86QN327LDOCUSATE SODIUM CAPSULE, LIQUID FILLED [BLENHEIM PHARMACAL, INC.]2
GLYCERININACTIVE INGREDIENTPDC6A3C0OXDOCUSATE SODIUM CAPSULE, LIQUID FILLED [BLENHEIM PHARMACAL, INC.]2
GLYCERININACTIVE INGREDIENTPDC6A3C0OXDOCUSATE SODIUM CAPSULE, LIQUID FILLED [UNIT DOSE SERVICES]2
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ADOCUSATE SODIUM CAPSULE, LIQUID FILLED [BLENHEIM PHARMACAL, INC.]2
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ADOCUSATE SODIUM CAPSULE, LIQUID FILLED [UNIT DOSE SERVICES]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3DOCUSATE SODIUM CAPSULE, LIQUID FILLED [UNIT DOSE SERVICES]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3DOCUSATE SODIUM CAPSULE, LIQUID FILLED [BLENHEIM PHARMACAL, INC.]2
SORBITOLINACTIVE INGREDIENT506T60A25RDOCUSATE SODIUM CAPSULE, LIQUID FILLED [UNIT DOSE SERVICES]2
SORBITOLINACTIVE INGREDIENT506T60A25RDOCUSATE SODIUM CAPSULE, LIQUID FILLED [BLENHEIM PHARMACAL, INC.]2
Docusate SodiumACTIVE INGREDIENTF05Q2T2JA0DOCUSATE SODIUM CAPSULE, LIQUID FILLED [PROFICIENT RX LP]1
Docusate SodiumACTIVE INGREDIENTF05Q2T2JA0DOCUSATE SODIUM (DOCUSATE SODIUM ) CAPSULE, LIQUID FILLED [SDA LABORATORIES, INC.]1
DOCUSATE SODIUMACTIVE INGREDIENTF05Q2T2JA0DOCUSATE SODIUM CAPSULE, LIQUID FILLED [LIBERTY PHARMACEUTICALS, INC.]1
DOCUSATEACTIVE MOIETYM7P27195AGDOCUSATE SODIUM CAPSULE, LIQUID FILLED [LIBERTY PHARMACEUTICALS, INC.]1
DocusateACTIVE MOIETYM7P27195AGDOCUSATE SODIUM CAPSULE, LIQUID FILLED [PROFICIENT RX LP]1
DocusateACTIVE MOIETYM7P27195AGDOCUSATE SODIUM (DOCUSATE SODIUM ) CAPSULE, LIQUID FILLED [SDA LABORATORIES, INC.]1
D&C RED NO. 33INACTIVE INGREDIENT9DBA0SBB0LDOCUSATE SODIUM CAPSULE, LIQUID FILLED [PROFICIENT RX LP]1
D&C RED NO. 33INACTIVE INGREDIENT9DBA0SBB0LDOCUSATE SODIUM (DOCUSATE SODIUM ) CAPSULE, LIQUID FILLED [SDA LABORATORIES, INC.]1
D&C RED NO. 33INACTIVE INGREDIENT9DBA0SBB0LDOCUSATE SODIUM CAPSULE, LIQUID FILLED [LIBERTY PHARMACEUTICALS, INC.]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOADOCUSATE SODIUM CAPSULE, LIQUID FILLED [LIBERTY PHARMACEUTICALS, INC.]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOADOCUSATE SODIUM (DOCUSATE SODIUM ) CAPSULE, LIQUID FILLED [SDA LABORATORIES, INC.]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOADOCUSATE SODIUM CAPSULE, LIQUID FILLED [PROFICIENT RX LP]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8DOCUSATE SODIUM CAPSULE, LIQUID FILLED [LIBERTY PHARMACEUTICALS, INC.]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8DOCUSATE SODIUM CAPSULE, LIQUID FILLED [PROFICIENT RX LP]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8DOCUSATE SODIUM (DOCUSATE SODIUM ) CAPSULE, LIQUID FILLED [SDA LABORATORIES, INC.]1
GELATININACTIVE INGREDIENT2G86QN327LDOCUSATE SODIUM (DOCUSATE SODIUM ) CAPSULE, LIQUID FILLED [SDA LABORATORIES, INC.]1
GELATININACTIVE INGREDIENT2G86QN327LDOCUSATE SODIUM CAPSULE, LIQUID FILLED [PROFICIENT RX LP]1
GELATININACTIVE INGREDIENT2G86QN327LDOCUSATE SODIUM CAPSULE, LIQUID FILLED [LIBERTY PHARMACEUTICALS, INC.]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXDOCUSATE SODIUM CAPSULE, LIQUID FILLED [LIBERTY PHARMACEUTICALS, INC.]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXDOCUSATE SODIUM (DOCUSATE SODIUM ) CAPSULE, LIQUID FILLED [SDA LABORATORIES, INC.]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXDOCUSATE SODIUM CAPSULE, LIQUID FILLED [PROFICIENT RX LP]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ADOCUSATE SODIUM (DOCUSATE SODIUM ) CAPSULE, LIQUID FILLED [SDA LABORATORIES, INC.]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ADOCUSATE SODIUM CAPSULE, LIQUID FILLED [LIBERTY PHARMACEUTICALS, INC.]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ADOCUSATE SODIUM CAPSULE, LIQUID FILLED [PROFICIENT RX LP]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3DOCUSATE SODIUM (DOCUSATE SODIUM ) CAPSULE, LIQUID FILLED [SDA LABORATORIES, INC.]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3DOCUSATE SODIUM CAPSULE, LIQUID FILLED [PROFICIENT RX LP]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3DOCUSATE SODIUM CAPSULE, LIQUID FILLED [LIBERTY PHARMACEUTICALS, INC.]1
SORBITOLINACTIVE INGREDIENT506T60A25RDOCUSATE SODIUM (DOCUSATE SODIUM ) CAPSULE, LIQUID FILLED [SDA LABORATORIES, INC.]1
SORBITOLINACTIVE INGREDIENT506T60A25RDOCUSATE SODIUM CAPSULE, LIQUID FILLED [LIBERTY PHARMACEUTICALS, INC.]1
SORBITOLINACTIVE INGREDIENT506T60A25RDOCUSATE SODIUM CAPSULE, LIQUID FILLED [PROFICIENT RX LP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66424-030DOCUSATE SODIUM (DOCUSATE SODIUM ) CAPSULE, LIQUID FILLED [SDA LABORATORIES, INC.]1Legacy NDC, 2 package rows20111117_d9480871-7671-450c-b7da-79ece4649c6c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1115005docusate sodium 100 MG Oral CapsulePSN33586efa-a589-49d7-8913-9d4503bfbe1f4
1115005docusate sodium 100 MG Oral CapsulePSNf9ac0344-5864-4ac1-81bc-16878a5946c54
1115005docusate sodium 100 MG Oral CapsuleSCD33586efa-a589-49d7-8913-9d4503bfbe1f4
1115005docusate sodium 100 MG Oral CapsuleSCDf9ac0344-5864-4ac1-81bc-16878a5946c54
1115005DOSS Sodium 100 MG Oral CapsuleSY33586efa-a589-49d7-8913-9d4503bfbe1f4
1115005DOSS Sodium 100 MG Oral CapsuleSYf9ac0344-5864-4ac1-81bc-16878a5946c54
1115005docusate sodium 100 MG Oral CapsulePSN117c82a6-2063-566b-e054-00144ff88e882
1115005docusate sodium 100 MG Oral CapsuleSCD117c82a6-2063-566b-e054-00144ff88e882
1115005DOSS Sodium 100 MG Oral CapsuleSY117c82a6-2063-566b-e054-00144ff88e882
1115005docusate sodium 100 MG Oral CapsulePSN785a0b85-c565-4fd9-a20f-6fa24df92d431
1115005docusate sodium 100 MG Oral CapsulePSNd9480871-7671-450c-b7da-79ece4649c6c1
1115005docusate sodium 100 MG Oral CapsuleSCD785a0b85-c565-4fd9-a20f-6fa24df92d431
1115005docusate sodium 100 MG Oral CapsuleSCDd9480871-7671-450c-b7da-79ece4649c6c1
1115005DOSS Sodium 100 MG Oral CapsuleSY785a0b85-c565-4fd9-a20f-6fa24df92d431
1115005DOSS Sodium 100 MG Oral CapsuleSYd9480871-7671-450c-b7da-79ece4649c6c1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
66424-030-0166424003001100 in 1 BOTTLEHistorical
66424-030-10664240030101000 in 1 BOTTLEHistorical