Senna/Docusate Sodium

Product NDC
0904-5643
Requested package NDC
0904-5643-61
11-digit product format
009045643
Labeler code
0904
Product ID
0904-5643_0c93d8c4-100c-4868-95c1-a889f58c04ae
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
2010-01-01
Marketing end
2022-05-31
Substance
SENNOSIDES; DOCUSATE SODIUM
Active strength
9 mg/1; 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 packagepackage0904-56430904-5643-61DDiscontinued 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 · 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
0904-5643-60EA - Each0904-5643672627f1-a8ac-46c7-b78a-454c6773bfdf12013-02-11
0904-5643-61EA - Each0904-56434c34882b-7edf-4eca-adef-036c1f6224c312013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DOCUSATE SODIUMACTIVE INGREDIENTF05Q2T2JA0DOK PLUS TABLET [CARDINAL HEALTH]6
SENNOSIDESACTIVE INGREDIENT3FYP5M0IJXDOK PLUS TABLET [CARDINAL HEALTH]6
DOCUSATEACTIVE MOIETYM7P27195AGDOK PLUS TABLET [CARDINAL HEALTH]6
SENNOSIDESACTIVE MOIETY3FYP5M0IJXDOK PLUS TABLET [CARDINAL HEALTH]6
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSINACTIVE INGREDIENTL11K75P92JDOK PLUS TABLET [CARDINAL HEALTH]6
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZDOK PLUS TABLET [CARDINAL HEALTH]6
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UDOK PLUS TABLET [CARDINAL HEALTH]6
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48DOK PLUS TABLET [CARDINAL HEALTH]6
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOADOK PLUS TABLET [CARDINAL HEALTH]6
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WODOK PLUS TABLET [CARDINAL HEALTH]6
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30DOK PLUS TABLET [CARDINAL HEALTH]6
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQDOK PLUS TABLET [CARDINAL HEALTH]6
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4DOK PLUS TABLET [CARDINAL HEALTH]6
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUDOK PLUS TABLET [CARDINAL HEALTH]6
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APDOK PLUS TABLET [CARDINAL HEALTH]6
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPDOK PLUS TABLET [CARDINAL HEALTH]6
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
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZSENNA/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 RED NO. 40INACTIVE INGREDIENTWZB9127XOASENNA/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
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
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4SENNA/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
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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0904-5643-6100904564361100 BLISTER PACK in 1 BOX, UNIT-DOSE (0904-5643-61) > 1 TABLET, FILM COATED in 1 BLISTER PACK100 blister pack2010-01-012022-03-31NoNoCurrent