FDA.reportPublic FDA data

Sankaijo

Product NDC
49873-404
11-digit product format
498730404
Labeler code
49873
Product ID
49873-404_0b54b2d1-83e7-3a18-e063-6394a90a5b58
Type
HUMAN OTC DRUG
Nonproprietary name
docusate sodium, sennosides
Dosage form
TABLET
Route
ORAL
Labeler
Sato Pharmaceutical Co., Ltd.
Application
M007
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2002-12-20
Substance
DOCUSATE SODIUM; SENNOSIDES
Active strength
8.33; 1.36 mg/1; mg/1
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

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 · 4 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2019-12-08 06:16 UTC · source 2019-12-05unfinished productproduct263afe128892…91768de4ddbe…
2019-12-08 06:16 UTC · source 2019-12-05unfinished packagepackage49873-404-90263afe128892…91768de4ddbe…
2019-06-01 22:24 UTC · source 2019-05-30unfinished productproduct5b2001dcd8f5…54b53d4dc9e4…
2019-06-01 22:24 UTC · source 2019-05-30unfinished packagepackage49873-404-905b2001dcd8f5…54b53d4dc9e4…

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
Sankaijo
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DOCUSATE SODIUM8.33 mg/1
SENNOSIDES1.36 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
F05Q2T2JA0Internal UNII lookup
3FYP5M0IJXInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1235252Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
83c0d52b-f7e2-40b0-a01b-1ccee78f8f1bAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49873-404-01Sankaijo1 in 1 CARTONTABLET111
49873-404-01Sankaijo150 in 1 BOTTLETABLET15011

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
docusate sodiumACTIVE INGREDIENTF05Q2T2JA0SANKAIJO (DOCUSATE SODIUM, SENNOSIDES) TABLET [SATO PHARMACEUTICAL CO., LTD.]6
SENNOSIDESACTIVE INGREDIENT3FYP5M0IJXSANKAIJO (DOCUSATE SODIUM, SENNOSIDES) TABLET [SATO PHARMACEUTICAL CO., LTD.]6
docusateACTIVE MOIETYM7P27195AGSANKAIJO (DOCUSATE SODIUM, SENNOSIDES) TABLET [SATO PHARMACEUTICAL CO., LTD.]6
SENNOSIDESACTIVE MOIETY3FYP5M0IJXSANKAIJO (DOCUSATE SODIUM, SENNOSIDES) TABLET [SATO PHARMACEUTICAL CO., LTD.]6
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSINACTIVE INGREDIENTL11K75P92JSANKAIJO (DOCUSATE SODIUM, SENNOSIDES) TABLET [SATO PHARMACEUTICAL CO., LTD.]6
caramelINACTIVE INGREDIENTT9D99G2B1RSANKAIJO (DOCUSATE SODIUM, SENNOSIDES) TABLET [SATO PHARMACEUTICAL CO., LTD.]6
CARBOXYMETHYLCELLULOSE CALCIUMINACTIVE INGREDIENTUTY7PDF93LSANKAIJO (DOCUSATE SODIUM, SENNOSIDES) TABLET [SATO PHARMACEUTICAL CO., LTD.]6
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61USANKAIJO (DOCUSATE SODIUM, SENNOSIDES) TABLET [SATO PHARMACEUTICAL CO., LTD.]6
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1OSANKAIJO (DOCUSATE SODIUM, SENNOSIDES) TABLET [SATO PHARMACEUTICAL CO., LTD.]6
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKSANKAIJO (DOCUSATE SODIUM, SENNOSIDES) TABLET [SATO PHARMACEUTICAL CO., LTD.]6
FENNELINACTIVE INGREDIENT557II4LLC3SANKAIJO (DOCUSATE SODIUM, SENNOSIDES) TABLET [SATO PHARMACEUTICAL CO., LTD.]6
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675SANKAIJO (DOCUSATE SODIUM, SENNOSIDES) TABLET [SATO PHARMACEUTICAL CO., LTD.]6
HYPROMELLOSE 2910 (15000 MPA.S)INACTIVE INGREDIENT288VBX44JCSANKAIJO (DOCUSATE SODIUM, SENNOSIDES) TABLET [SATO PHARMACEUTICAL CO., LTD.]6
IPOMOEA NIL SEEDINACTIVE INGREDIENTI85W45B4WBSANKAIJO (DOCUSATE SODIUM, SENNOSIDES) TABLET [SATO PHARMACEUTICAL CO., LTD.]6
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30SANKAIJO (DOCUSATE SODIUM, SENNOSIDES) TABLET [SATO PHARMACEUTICAL CO., LTD.]6
PAEONIA SUFFRUTICOSA ROOT BARKINACTIVE INGREDIENTBUG255FE7XSANKAIJO (DOCUSATE SODIUM, SENNOSIDES) TABLET [SATO PHARMACEUTICAL CO., LTD.]6
PEG/PPG-105/5 COPOLYMERINACTIVE INGREDIENT52901V8XARSANKAIJO (DOCUSATE SODIUM, SENNOSIDES) TABLET [SATO PHARMACEUTICAL CO., LTD.]6
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4SANKAIJO (DOCUSATE SODIUM, SENNOSIDES) TABLET [SATO PHARMACEUTICAL CO., LTD.]6
TALCINACTIVE INGREDIENT7SEV7J4R1USANKAIJO (DOCUSATE SODIUM, SENNOSIDES) TABLET [SATO PHARMACEUTICAL CO., LTD.]6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49873-404SANKAIJO (DOCUSATE SODIUM, SENNOSIDES) TABLET [SATO PHARMACEUTICAL CO., LTD.]11Current NDC, Legacy NDC, 2 package rows20231130_83c0d52b-f7e2-40b0-a01b-1ccee78f8f1b.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 2 of 43 · 858 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Epsom SaltMAGNESIUM SULFATECardinal Health, 110 dba Leaderd27dc1cc-5e17-40d3-84fe-c1792552cfd52026-08-25Warnings, Adverse reactionsExact identifier
application number: M007
HyVee Senna SDOCUSATE SODIUM, SENNOSIDESHyVee Inc4982b9c6-ed0e-24da-e063-6394a90a147f2026-08-24WarningsExact identifier
application number: M007
Stool Softener LaxativeDOCUSATE SODIUMDolgencorp, Inc. (DOLLAR GENERAL & REXALL)ccec364a-3135-4a5d-b4b0-86b832387b4e2026-08-24WarningsExact identifier
application number: M007
ColaceDOCUSATE SODIUMAtlantis Consumer Healthcare, Inc.a1591da0-a1a9-9583-3cf5-788b8fee38142026-08-24Exact identifier
application number: M007
MiraFAST soft chewsMAGNESIUM HYDROXIDEBayer HealthCare LLC.2cee67dd-b71f-32b8-e063-6394a90ae8642026-08-21WarningsExact identifier
application number: M007
HyVee Senna SDOCUSATE SODIUM, SENNOSIDESHyVee Inc49837b2c-492f-2fed-e063-6294a90aaa242026-08-21WarningsExact identifier
application number: M007
Senokot-SSTANDARDIZED SENNA CONCENTRATE AND DOCUSATE SODIUMAtlantis Consumer Healthcare, Inc.c24cdc5e-62e0-41a6-8afb-512202a569f42026-08-21WarningsExact identifier
application number: M007
Foster and Thrive Senna-S Sennosides and Docusate Sodium Laxative and Stool SoftenerDOCUSATE SODIUM 50MG AND SENNOSIDES 8.6MGStrategic Sourcing Services LLC5966ff80-7be2-788a-e063-6294a90ab4f32026-08-19WarningsExact identifier
application number: M007
Epsom SaltEPSOM SALTAmerisourceBergen (Good Neighbor Pharmacy) 46122d22fb02f-09c4-476a-b6d6-d3a2fd30049d2026-08-18WarningsExact identifier
application number: M007
FiberconCALCIUM POLYCARBOPHILMedtech Products Inc.59534afd-fe38-818a-e063-6394a90a21ea2026-08-18WarningsExact identifier
application number: M007
CVS Stool Softener Fruit PunchDOCUSATE SODIUMCVS PHARMACY, INC0e6900d6-7dc9-47d6-a006-1695feb8d5a52026-08-17WarningsExact identifier
application number: M007
CVS Senna LaxativeSENNOSIDESCVS PHARMACY5a5565b2-827f-4fcc-a835-d827f62da8f92026-08-17WarningsExact identifier
application number: M007
Stool Softener LaxativeDOCUSATE SODIUMDolgencorp, Inc. (DOLLAR GENERAL & REXALL)306fd12b-ed60-40dc-a5be-2dc394bd29d22026-08-17WarningsExact identifier
application number: M007
CVS Health Childrens Saline LaxativeMAGNESIUM HYDROXIDECVS PHARMACY,INC.e57e5529-2190-4c66-8397-bc2848739e592026-08-14WarningsExact identifier
application number: M007
Docusate Sodium and SennosidesDOCUSATE SODIUM AND SENNOSIDESMorepen Bio Inc562d1b9a-09d8-92fc-e063-6394a90a19932026-08-14WarningsExact identifier
application number: M007
CVS HealthNATURAL FIBER SUPPLEMENTCVS Pharmacy,Inc.04dbe9aa-ed18-4d76-a840-d010445a86432026-08-14WarningsExact identifier
application number: M007
CVS Fiber TherapyMETHYLCELLULOSECVS PHARMACYe066f5bd-5f34-4e04-beec-3c7d6db493812026-08-13WarningsExact identifier
application number: M007
Mineral oilMINERAL OILEQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)92f2147d-b52d-4282-b217-28f6095dca0e2026-08-12WarningsExact identifier
application number: M007
CAREONE Orange FlavoredPSYLLIUM HUSKFOODHOLD USA4b1cccd2-e941-4d51-9924-4ca35e3a44292026-08-11WarningsExact identifier
application number: M007
CAREONEPSYLLIUM HUSKFOODHOLD USA3ec3ead0-382e-4765-bbe8-b21e7c7b42a62026-08-11WarningsExact identifier
application number: M007

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1235252docusate sodium 8.33 MG / sennosides 1.36 MG Oral TabletPSN83c0d52b-f7e2-40b0-a01b-1ccee78f8f1b11
1235252docusate sodium 8.33 MG / sennosides, USP 1.36 MG Oral TabletSCD83c0d52b-f7e2-40b0-a01b-1ccee78f8f1b11
1235252DOSS Sodium 8.33 MG / sennosides, USP 1.36 MG Oral TabletSY83c0d52b-f7e2-40b0-a01b-1ccee78f8f1b11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49873-404-01498730404011 BOTTLE in 1 CARTON (49873-404-01) / 150 TABLET in 1 BOTTLE1 bottle2002-12-200000-00-00NoNoCurrent