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

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 Identifiers#

Field, Values table
FieldValues
UniiF05Q2T2JA0, 3FYP5M0IJX
Rxcui1235252

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

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