DOK

Product NDC
0904-6457
Requested package NDC
0904-6457-80
11-digit product format
009046457
Labeler code
0904
Product ID
0904-6457_a9b60d60-41e9-4aa5-b207-9e9efa7e5169
Type
HUMAN OTC DRUG
Nonproprietary name
DOCUSATE SODIUM
Dosage form
CAPSULE
Route
ORAL
Labeler
Major Pharmaceuticals
Application
part334
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2015-02-28
Marketing end
2024-01-28
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage0904-64570904-6457-80DDiscontinued 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 · 12 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…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
0904-6457-60EA - Each0904-6457f74e1376-7353-4058-ae1c-b0189c2e036012015-06-09
0904-6457-80EA - Each0904-6457e11f74e7-d452-4fdd-8512-5c99127d2d2912015-06-09

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DOCUSATE SODIUMACTIVE INGREDIENTF05Q2T2JA0DOCUSATE SODIUM CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]5
DOCUSATEACTIVE MOIETYM7P27195AGDOCUSATE SODIUM CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]5
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOADOCUSATE SODIUM CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]5
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8DOCUSATE SODIUM CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]5
GELATININACTIVE INGREDIENT2G86QN327LDOCUSATE SODIUM CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]5
GLYCERININACTIVE INGREDIENTPDC6A3C0OXDOCUSATE SODIUM CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]5
MEDIUM-CHAIN TRIGLYCERIDESINACTIVE INGREDIENTC9H2L21V7UDOCUSATE SODIUM CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]5
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ADOCUSATE SODIUM CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]5
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3DOCUSATE SODIUM CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]5
SORBITANINACTIVE INGREDIENT6O92ICV9RUDOCUSATE SODIUM CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]5
SORBITOLINACTIVE INGREDIENT506T60A25RDOCUSATE SODIUM CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]5
WATERINACTIVE INGREDIENT059QF0KO0RDOCUSATE SODIUM CAPSULE [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]5
DOCUSATE SODIUMACTIVE INGREDIENTF05Q2T2JA0DOK (DOCUSATE SODIUM) CAPSULE [MAJOR PHARMACEUTICALS]2
DOCUSATEACTIVE MOIETYM7P27195AGDOK (DOCUSATE SODIUM) CAPSULE [MAJOR PHARMACEUTICALS]2
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOADOK (DOCUSATE SODIUM) CAPSULE [MAJOR PHARMACEUTICALS]2
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8DOK (DOCUSATE SODIUM) CAPSULE [MAJOR PHARMACEUTICALS]2
GELATININACTIVE INGREDIENT2G86QN327LDOK (DOCUSATE SODIUM) CAPSULE [MAJOR PHARMACEUTICALS]2
GLYCERININACTIVE INGREDIENTPDC6A3C0OXDOK (DOCUSATE SODIUM) CAPSULE [MAJOR PHARMACEUTICALS]2
MEDIUM-CHAIN TRIGLYCERIDESINACTIVE INGREDIENTC9H2L21V7UDOK (DOCUSATE SODIUM) CAPSULE [MAJOR PHARMACEUTICALS]2
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ADOK (DOCUSATE SODIUM) CAPSULE [MAJOR PHARMACEUTICALS]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3DOK (DOCUSATE SODIUM) CAPSULE [MAJOR PHARMACEUTICALS]2
SORBITANINACTIVE INGREDIENT6O92ICV9RUDOK (DOCUSATE SODIUM) CAPSULE [MAJOR PHARMACEUTICALS]2
SORBITOLINACTIVE INGREDIENT506T60A25RDOK (DOCUSATE SODIUM) CAPSULE [MAJOR PHARMACEUTICALS]2
WATERINACTIVE INGREDIENT059QF0KO0RDOK (DOCUSATE SODIUM) CAPSULE [MAJOR PHARMACEUTICALS]2

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1115005docusate sodium 100 MG Oral CapsulePSNe5d7f7e7-c091-4546-9076-7672b1b7b7a85
1483571DOK 100 MG Oral CapsulePSNe5d7f7e7-c091-4546-9076-7672b1b7b7a85
1483571docusate sodium 100 MG Oral Capsule [DOK]SBDe5d7f7e7-c091-4546-9076-7672b1b7b7a85
1115005docusate sodium 100 MG Oral CapsuleSCDe5d7f7e7-c091-4546-9076-7672b1b7b7a85
1483571DOK 100 MG Oral CapsuleSYe5d7f7e7-c091-4546-9076-7672b1b7b7a85
1115005DOSS Sodium 100 MG Oral CapsuleSYe5d7f7e7-c091-4546-9076-7672b1b7b7a85
1483571DOSS Sodium 100 MG Oral Capsule [DOK]SYe5d7f7e7-c091-4546-9076-7672b1b7b7a85
1115005docusate sodium 100 MG Oral CapsulePSN68165491-0e0c-52d9-e053-2a91aa0ae5f12
1115005docusate sodium 100 MG Oral CapsuleSCD68165491-0e0c-52d9-e053-2a91aa0ae5f12
1115005DOSS Sodium 100 MG Oral CapsuleSY68165491-0e0c-52d9-e053-2a91aa0ae5f12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0904-6457-80009046457801000 CAPSULE in 1 BOTTLE, PLASTIC (0904-6457-80) 1000 capsule2015-02-282024-01-28NoNoCurrent