DOK

Product NDC
0904-6458
11-digit product format
009046458
Labeler code
0904
Product ID
0904-6458_e5db4d6e-7c15-4951-b27f-91d439ef57d8
Type
HUMAN OTC DRUG
Nonproprietary name
DOCUSATE SODIUM
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
Major Pharmaceuticals
Application
part334
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2015-02-28
Marketing end
2021-12-30
Substance
DOCUSATE SODIUM
Active strength
250 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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct0904-6458DDiscontinued by firm2026-10-05
excluded packagepackage0904-64580904-6458-59DDiscontinued 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 · 24 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 packagepackage0904-6458-59d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0904-6458-59f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0904-6458-592ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0904-6458-59a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0904-6458-59cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0904-6458-59cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0904-6458-59302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0904-6458-59ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0904-6458-590efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0904-6458-59ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0904-6458-59367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0904-6458-59557ba5c1ecfa…9c80585c8c6e…

Reported adverse events (FAERS/openFDA)#

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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-6458-59EA - Each0904-6458b0e24221-af9d-44a1-a6af-846d0b688f8012015-06-09

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DOCUSATE SODIUMACTIVE INGREDIENTF05Q2T2JA0DOCUSATE SODIUM CAPSULE, LIQUID FILLED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]4
DOCUSATEACTIVE MOIETYM7P27195AGDOCUSATE SODIUM CAPSULE, LIQUID FILLED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]4
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOADOCUSATE SODIUM CAPSULE, LIQUID FILLED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]4
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8DOCUSATE SODIUM CAPSULE, LIQUID FILLED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]4
GELATININACTIVE INGREDIENT2G86QN327LDOCUSATE SODIUM CAPSULE, LIQUID FILLED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]4
GLYCERININACTIVE INGREDIENTPDC6A3C0OXDOCUSATE SODIUM CAPSULE, LIQUID FILLED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]4
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ADOCUSATE SODIUM CAPSULE, LIQUID FILLED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]4
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3DOCUSATE SODIUM CAPSULE, LIQUID FILLED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]4
SORBITANINACTIVE INGREDIENT6O92ICV9RUDOCUSATE SODIUM CAPSULE, LIQUID FILLED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]4
SORBITOLINACTIVE INGREDIENT506T60A25RDOCUSATE SODIUM CAPSULE, LIQUID FILLED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]4
WATERINACTIVE INGREDIENT059QF0KO0RDOCUSATE SODIUM CAPSULE, LIQUID FILLED [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]4
DOCUSATE SODIUMACTIVE INGREDIENTF05Q2T2JA0DOK (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [MAJOR PHARMACEUTICALS]2
DOCUSATEACTIVE MOIETYM7P27195AGDOK (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [MAJOR PHARMACEUTICALS]2
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOADOK (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [MAJOR PHARMACEUTICALS]2
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8DOK (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [MAJOR PHARMACEUTICALS]2
GELATININACTIVE INGREDIENT2G86QN327LDOK (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [MAJOR PHARMACEUTICALS]2
GLYCERININACTIVE INGREDIENTPDC6A3C0OXDOK (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [MAJOR PHARMACEUTICALS]2
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ADOK (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [MAJOR PHARMACEUTICALS]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3DOK (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [MAJOR PHARMACEUTICALS]2
SORBITANINACTIVE INGREDIENT6O92ICV9RUDOK (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [MAJOR PHARMACEUTICALS]2
SORBITOLINACTIVE INGREDIENT506T60A25RDOK (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [MAJOR PHARMACEUTICALS]2
WATERINACTIVE INGREDIENT059QF0KO0RDOK (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [MAJOR PHARMACEUTICALS]2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0904-6458-5900904645859100 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (0904-6458-59) 2015-02-282021-12-30NoNoCurrent