Senna/Docusate Sodium

Product NDC
0904-5512
11-digit product format
009045512
Labeler code
0904
Product ID
0904-5512_a68f4aa3-d072-49f2-9782-c41d116e8323
Type
HUMAN OTC DRUG
Nonproprietary name
Docusate sodium and Sennosides
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Major Pharmaceuticals
Application
part334
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2011-06-16
Marketing end
0000-00-00
Substance
DOCUSATE SODIUM; SENNOSIDES
Active strength
50 mg/1; mg/1
NDC exclude flag
No
Listing certified through
2019-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct0904-5512DDiscontinued by firm2026-10-15
excluded packagepackage0904-55120904-5512-61DDiscontinued by firm2026-10-15

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 packagepackage0904-5512-61d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0904-5512-61f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0904-5512-612ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0904-5512-61a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0904-5512-61cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0904-5512-61cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0904-5512-61302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0904-5512-61ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0904-5512-610efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0904-5512-61ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0904-5512-61367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0904-5512-61557ba5c1ecfa…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
0904-5512-52EA - Each0904-551220d61bdf-b11e-4f8b-9db0-7d3b83cbb7d312013-02-11
0904-5512-61EA - Each0904-55124a6495c4-71eb-4dd0-8405-6fc8d09074ab12013-02-13
0904-5512-80EA - Each0904-55125a94eafc-67ec-44d3-9345-15e866beded812013-02-11

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DOCUSATE SODIUMACTIVE INGREDIENTF05Q2T2JA0SENNA PLUS (SENNOSIDES AND DOCUSATE SODIUM) TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]8
SENNOSIDESACTIVE INGREDIENT3FYP5M0IJXSENNA PLUS (SENNOSIDES AND DOCUSATE SODIUM) TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]8
DOCUSATEACTIVE MOIETYM7P27195AGSENNA PLUS (SENNOSIDES AND DOCUSATE SODIUM) TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]8
SENNOSIDESACTIVE MOIETY3FYP5M0IJXSENNA PLUS (SENNOSIDES AND DOCUSATE SODIUM) TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]8
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSINACTIVE INGREDIENTL11K75P92JSENNA PLUS (SENNOSIDES AND DOCUSATE SODIUM) TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]8
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61USENNA PLUS (SENNOSIDES AND DOCUSATE SODIUM) TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]8
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48SENNA PLUS (SENNOSIDES AND DOCUSATE SODIUM) TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]8
FD&C YELLOW NO. 5INACTIVE INGREDIENTI753WB2F1MSENNA PLUS (SENNOSIDES AND DOCUSATE SODIUM) TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]8
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8SENNA PLUS (SENNOSIDES AND DOCUSATE SODIUM) TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]8
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOSENNA PLUS (SENNOSIDES AND DOCUSATE SODIUM) TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]8
MAGNESIUM SILICATEINACTIVE INGREDIENT9B9691B2N9SENNA PLUS (SENNOSIDES AND DOCUSATE SODIUM) TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]8
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30SENNA PLUS (SENNOSIDES AND DOCUSATE SODIUM) TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]8
MINERAL OILINACTIVE INGREDIENTT5L8T28FGPSENNA PLUS (SENNOSIDES AND DOCUSATE SODIUM) TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]8
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ASENNA PLUS (SENNOSIDES AND DOCUSATE SODIUM) TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]8
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUSENNA PLUS (SENNOSIDES AND DOCUSATE SODIUM) TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]8
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JSENNA PLUS (SENNOSIDES AND DOCUSATE SODIUM) TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]8
STARCH, TAPIOCAINACTIVE INGREDIENT24SC3U704ISENNA PLUS (SENNOSIDES AND DOCUSATE SODIUM) TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]8
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APSENNA PLUS (SENNOSIDES AND DOCUSATE SODIUM) TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]8
TARTARIC ACIDINACTIVE INGREDIENTW4888I119HSENNA PLUS (SENNOSIDES AND DOCUSATE SODIUM) TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]8
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPSENNA PLUS (SENNOSIDES AND DOCUSATE SODIUM) TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]8
TRIACETININACTIVE INGREDIENTXHX3C3X673SENNA PLUS (SENNOSIDES AND DOCUSATE SODIUM) TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]8
DOCUSATE SODIUMACTIVE INGREDIENTF05Q2T2JA0SENNA/DOCUSATE SODIUM (DOCUSATE SODIUM AND SENNOSIDES) TABLET, FILM COATED [MAJOR PHARMACEUTICALS]5
SENNOSIDESACTIVE INGREDIENT3FYP5M0IJXSENNA/DOCUSATE SODIUM (DOCUSATE SODIUM AND SENNOSIDES) TABLET, FILM COATED [MAJOR PHARMACEUTICALS]5
DOCUSATEACTIVE MOIETYM7P27195AGSENNA/DOCUSATE SODIUM (DOCUSATE SODIUM AND SENNOSIDES) TABLET, FILM COATED [MAJOR PHARMACEUTICALS]5
SENNOSIDESACTIVE MOIETY3FYP5M0IJXSENNA/DOCUSATE SODIUM (DOCUSATE SODIUM AND SENNOSIDES) TABLET, FILM COATED [MAJOR PHARMACEUTICALS]5
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATEINACTIVE INGREDIENTO7TSZ97GEPSENNA/DOCUSATE SODIUM (DOCUSATE SODIUM AND SENNOSIDES) TABLET, FILM COATED [MAJOR PHARMACEUTICALS]5
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61USENNA/DOCUSATE SODIUM (DOCUSATE SODIUM AND SENNOSIDES) TABLET, FILM COATED [MAJOR PHARMACEUTICALS]5
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48SENNA/DOCUSATE SODIUM (DOCUSATE SODIUM AND SENNOSIDES) TABLET, FILM COATED [MAJOR PHARMACEUTICALS]5
FD&C YELLOW NO. 5INACTIVE INGREDIENTI753WB2F1MSENNA/DOCUSATE SODIUM (DOCUSATE SODIUM AND SENNOSIDES) TABLET, FILM COATED [MAJOR PHARMACEUTICALS]5
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8SENNA/DOCUSATE SODIUM (DOCUSATE SODIUM AND SENNOSIDES) TABLET, FILM COATED [MAJOR PHARMACEUTICALS]5
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOSENNA/DOCUSATE SODIUM (DOCUSATE SODIUM AND SENNOSIDES) TABLET, FILM COATED [MAJOR PHARMACEUTICALS]5
LIGHT MINERAL OILINACTIVE INGREDIENTN6K5787QVPSENNA/DOCUSATE SODIUM (DOCUSATE SODIUM AND SENNOSIDES) TABLET, FILM COATED [MAJOR PHARMACEUTICALS]5
MAGNESIUM SILICATEINACTIVE INGREDIENT9B9691B2N9SENNA/DOCUSATE SODIUM (DOCUSATE SODIUM AND SENNOSIDES) TABLET, FILM COATED [MAJOR PHARMACEUTICALS]5
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30SENNA/DOCUSATE SODIUM (DOCUSATE SODIUM AND SENNOSIDES) TABLET, FILM COATED [MAJOR PHARMACEUTICALS]5
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ASENNA/DOCUSATE SODIUM (DOCUSATE SODIUM AND SENNOSIDES) TABLET, FILM COATED [MAJOR PHARMACEUTICALS]5
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUSENNA/DOCUSATE SODIUM (DOCUSATE SODIUM AND SENNOSIDES) TABLET, FILM COATED [MAJOR PHARMACEUTICALS]5
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JSENNA/DOCUSATE SODIUM (DOCUSATE SODIUM AND SENNOSIDES) TABLET, FILM COATED [MAJOR PHARMACEUTICALS]5
STARCH, TAPIOCAINACTIVE INGREDIENT24SC3U704ISENNA/DOCUSATE SODIUM (DOCUSATE SODIUM AND SENNOSIDES) TABLET, FILM COATED [MAJOR PHARMACEUTICALS]5
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APSENNA/DOCUSATE SODIUM (DOCUSATE SODIUM AND SENNOSIDES) TABLET, FILM COATED [MAJOR PHARMACEUTICALS]5
TARTARIC ACIDINACTIVE INGREDIENTW4888I119HSENNA/DOCUSATE SODIUM (DOCUSATE SODIUM AND SENNOSIDES) TABLET, FILM COATED [MAJOR PHARMACEUTICALS]5
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPSENNA/DOCUSATE SODIUM (DOCUSATE SODIUM AND SENNOSIDES) TABLET, FILM COATED [MAJOR PHARMACEUTICALS]5