Docusate Sodium

Product NDC
63739-478
11-digit product format
637390478
Labeler code
63739
Product ID
63739-478_ca3f4d9b-3ee9-3040-e053-2995a90a4a82
Type
HUMAN OTC DRUG
Nonproprietary name
Docusate Sodium
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
McKesson Corporation
Application
part334
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2010-11-09
Marketing end
0000-00-00
Substance
DOCUSATE SODIUM
Active strength
100 mg/1
NDC exclude flag
No
Listing certified through
2022-12-31
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 · 6 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct63739-478DDiscontinued by firm2026-10-12
excluded packagepackage63739-47863739-478-01DDiscontinued by firm2026-10-12
excluded packagepackage63739-47863739-478-02DDiscontinued by firm2026-10-12
excluded packagepackage63739-47863739-478-10DDiscontinued by firm2026-10-12
excluded packagepackage63739-47863739-478-40DDiscontinued by firm2026-10-12
excluded packagepackage63739-47863739-478-48DDiscontinued by firm2026-10-12

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 1 · 48 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Package NDC, Snapshot table
Captured / source datePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-0563739-478-48d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-0563739-478-40d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-0563739-478-01d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-0563739-478-10d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-2663739-478-48f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-2663739-478-40f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-2663739-478-01f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-2663739-478-10f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-3163739-478-012ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-3163739-478-482ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-3163739-478-102ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-3163739-478-402ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-2863739-478-01a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-2863739-478-48a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-2863739-478-10a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-2863739-478-40a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-2163739-478-01cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-2163739-478-48cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-2163739-478-10cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-2163739-478-40cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-1063739-478-01cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-1063739-478-48cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-1063739-478-10cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-1063739-478-40cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-3163739-478-01302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-3163739-478-48302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-3163739-478-10302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-3163739-478-40302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-2063739-478-01ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-2063739-478-48ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-2063739-478-10ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-2063739-478-40ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-1063739-478-010efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-1063739-478-480efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-1063739-478-100efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-1063739-478-400efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-0863739-478-01ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-0863739-478-48ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-0863739-478-10ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-0863739-478-40ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-0363739-478-01367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-0363739-478-48367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-0363739-478-10367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-0363739-478-40367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-0963739-478-01557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-0963739-478-48557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-0963739-478-10557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-0963739-478-40557ba5c1ecfa…9c80585c8c6e…

Reported adverse events (FAERS/openFDA)#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
63739-478-012023-03-24Drug Facts
63739-478-022023-03-24Drug Facts
63739-478-102023-03-24Drug Facts
63739-478-402023-03-24Drug Facts
63739-478-482023-03-24Drug Facts
63739-478-012023-01-30Drug Facts
63739-478-022023-01-30Drug Facts
63739-478-102023-01-30Drug Facts
63739-478-402023-01-30Drug Facts
63739-478-482023-01-30Drug Facts

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63739-478-01EA - Each63739-478bb0a5458-5326-4332-96e8-f4c8db27a33812012-07-24
63739-478-02EA - Each63739-4786ce72269-cb12-4d4c-9885-bd94dc196fd012021-08-05
63739-478-04EA - Each63739-47884e7a142-cef0-4627-a16d-51bf1d56324112012-07-24
63739-478-10EA - Each63739-47814ed252d-3611-448d-ab07-80a2542843a112012-07-24
63739-478-40EA - Each63739-478b49aa50c-70b4-4599-80a0-c1b904ca3f8512017-11-06
63739-478-48EA - Each63739-47808b4cea1-4cb9-4d01-a857-e0f08a45439312017-11-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DOCUSATE SODIUMACTIVE INGREDIENTF05Q2T2JA0DOCUSATE SODIUM CAPSULE, LIQUID FILLED [CARDINAL HEALTH]5
DOCUSATEACTIVE MOIETYM7P27195AGDOCUSATE SODIUM CAPSULE, LIQUID FILLED [CARDINAL HEALTH]5
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GDOCUSATE SODIUM CAPSULE, LIQUID FILLED [CARDINAL HEALTH]5
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOADOCUSATE SODIUM CAPSULE, LIQUID FILLED [CARDINAL HEALTH]5
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8DOCUSATE SODIUM CAPSULE, LIQUID FILLED [CARDINAL HEALTH]5
GELATININACTIVE INGREDIENT2G86QN327LDOCUSATE SODIUM CAPSULE, LIQUID FILLED [CARDINAL HEALTH]5
GLYCERININACTIVE INGREDIENTPDC6A3C0OXDOCUSATE SODIUM CAPSULE, LIQUID FILLED [CARDINAL HEALTH]5
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ADOCUSATE SODIUM CAPSULE, LIQUID FILLED [CARDINAL HEALTH]5
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3DOCUSATE SODIUM CAPSULE, LIQUID FILLED [CARDINAL HEALTH]5
SORBITOLINACTIVE INGREDIENT506T60A25RDOCUSATE SODIUM CAPSULE, LIQUID FILLED [CARDINAL HEALTH]5
WATERINACTIVE INGREDIENT059QF0KO0RDOCUSATE SODIUM CAPSULE, LIQUID FILLED [CARDINAL HEALTH]5
DOCUSATE SODIUMACTIVE INGREDIENTF05Q2T2JA0DOCUSATE SODIUM CAPSULE, LIQUID FILLED [MCKESSON PACKAGING SERVICES BUSINESS UNIT OF MCKESSON CORPORATION]3
DOCUSATEACTIVE MOIETYM7P27195AGDOCUSATE SODIUM CAPSULE, LIQUID FILLED [MCKESSON PACKAGING SERVICES BUSINESS UNIT OF MCKESSON CORPORATION]3
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GDOCUSATE SODIUM CAPSULE, LIQUID FILLED [MCKESSON PACKAGING SERVICES BUSINESS UNIT OF MCKESSON CORPORATION]3
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOADOCUSATE SODIUM CAPSULE, LIQUID FILLED [MCKESSON PACKAGING SERVICES BUSINESS UNIT OF MCKESSON CORPORATION]3
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8DOCUSATE SODIUM CAPSULE, LIQUID FILLED [MCKESSON PACKAGING SERVICES BUSINESS UNIT OF MCKESSON CORPORATION]3
GELATININACTIVE INGREDIENT2G86QN327LDOCUSATE SODIUM CAPSULE, LIQUID FILLED [MCKESSON PACKAGING SERVICES BUSINESS UNIT OF MCKESSON CORPORATION]3
GLYCERININACTIVE INGREDIENTPDC6A3C0OXDOCUSATE SODIUM CAPSULE, LIQUID FILLED [MCKESSON PACKAGING SERVICES BUSINESS UNIT OF MCKESSON CORPORATION]3
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ADOCUSATE SODIUM CAPSULE, LIQUID FILLED [MCKESSON PACKAGING SERVICES BUSINESS UNIT OF MCKESSON CORPORATION]3
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3DOCUSATE SODIUM CAPSULE, LIQUID FILLED [MCKESSON PACKAGING SERVICES BUSINESS UNIT OF MCKESSON CORPORATION]3
SORBITOLINACTIVE INGREDIENT506T60A25RDOCUSATE SODIUM CAPSULE, LIQUID FILLED [MCKESSON PACKAGING SERVICES BUSINESS UNIT OF MCKESSON CORPORATION]3
WATERINACTIVE INGREDIENT059QF0KO0RDOCUSATE SODIUM CAPSULE, LIQUID FILLED [MCKESSON PACKAGING SERVICES BUSINESS UNIT OF MCKESSON CORPORATION]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63739-478DOCUSATE SODIUM CAPSULE, LIQUID FILLED [MCKESSON CORPORATION]12Legacy NDC20250424_48555cc1-a711-411f-a384-550116da1d3c.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63739-478-026373904780230 BLISTER PACK in 1 BOX, UNIT-DOSE (63739-478-02) > 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK30 blister pack2021-07-010000-00-00NoNoCurrent