FDA.reportPublic FDA data

KAO- TIN

Product NDC
0904-5779
11-digit product format
009045779
Labeler code
0904
Product ID
0904-5779_01231f2e-f609-4cc1-b7bc-a0e35eb9294e
Type
HUMAN OTC DRUG
Nonproprietary name
DOCUSATE CALCIUM
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
Major Pharmaceuticals
Application
part334
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2011-12-01
Marketing end
2020-12-31
Substance
DOCUSATE CALCIUM
Active strength
240 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 productproduct0904-5779DDiscontinued by firm2026-08-17
excluded packagepackage0904-57790904-5779-40DDiscontinued by firm2026-08-17
excluded packagepackage0904-57790904-5779-60DDiscontinued by firm2026-08-17

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 packagepackage0904-5779-40d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0904-5779-60d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0904-5779-40f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0904-5779-60f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0904-5779-402ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0904-5779-602ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0904-5779-40a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0904-5779-60a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0904-5779-40cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0904-5779-60cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0904-5779-40cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0904-5779-60cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0904-5779-40302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0904-5779-60302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0904-5779-40ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0904-5779-60ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0904-5779-400efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0904-5779-600efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0904-5779-40ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0904-5779-60ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0904-5779-40367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0904-5779-60367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0904-5779-40557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0904-5779-60557ba5c1ecfa…9c80585c8c6e…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-5779-40EA - Each0904-57790d3621e5-ec40-4238-b60e-6d4989336b7512013-02-13
0904-5779-60EA - Each0904-57798d6f8a42-2696-40b1-8fc9-cf545d50fa6312013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DOCUSATE CALCIUMACTIVE INGREDIENT6K7YS503HCDOCUSATE CALCIUM CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]3
DOCUSATEACTIVE MOIETYM7P27195AGDOCUSATE CALCIUM CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]3
CORN OILINACTIVE INGREDIENT8470G57WFMDOCUSATE CALCIUM CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]3
D&C RED NO. 33INACTIVE INGREDIENT9DBA0SBB0LDOCUSATE CALCIUM CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]3
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOADOCUSATE CALCIUM CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]3
GELATININACTIVE INGREDIENT2G86QN327LDOCUSATE CALCIUM CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]3
GLYCERININACTIVE INGREDIENTPDC6A3C0OXDOCUSATE CALCIUM CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]3
SORBITOLINACTIVE INGREDIENT506T60A25RDOCUSATE CALCIUM CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]3
WATERINACTIVE INGREDIENT059QF0KO0RDOCUSATE CALCIUM CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]3
DOCUSATE CALCIUMACTIVE INGREDIENT6K7YS503HCKAO- TIN (DOCUSATE CALCIUM) CAPSULE, LIQUID FILLED [MAJOR PHARMACEUTICALS]1
DOCUSATEACTIVE MOIETYM7P27195AGKAO- TIN (DOCUSATE CALCIUM) CAPSULE, LIQUID FILLED [MAJOR PHARMACEUTICALS]1
CORN OILINACTIVE INGREDIENT8470G57WFMKAO- TIN (DOCUSATE CALCIUM) CAPSULE, LIQUID FILLED [MAJOR PHARMACEUTICALS]1
D&C RED NO. 33INACTIVE INGREDIENT9DBA0SBB0LKAO- TIN (DOCUSATE CALCIUM) CAPSULE, LIQUID FILLED [MAJOR PHARMACEUTICALS]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAKAO- TIN (DOCUSATE CALCIUM) CAPSULE, LIQUID FILLED [MAJOR PHARMACEUTICALS]1
GELATININACTIVE INGREDIENT2G86QN327LKAO- TIN (DOCUSATE CALCIUM) CAPSULE, LIQUID FILLED [MAJOR PHARMACEUTICALS]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXKAO- TIN (DOCUSATE CALCIUM) CAPSULE, LIQUID FILLED [MAJOR PHARMACEUTICALS]1
SORBITOLINACTIVE INGREDIENT506T60A25RKAO- TIN (DOCUSATE CALCIUM) CAPSULE, LIQUID FILLED [MAJOR PHARMACEUTICALS]1
WATERINACTIVE INGREDIENT059QF0KO0RKAO- TIN (DOCUSATE CALCIUM) CAPSULE, LIQUID FILLED [MAJOR PHARMACEUTICALS]1