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 date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2019-12-08 06:16 UTC · source 2019-12-05	unfinished product	product		`263afe128892…`	`91768de4ddbe…`
2019-12-08 06:16 UTC · source 2019-12-05	unfinished package	package	49873-404-90	`263afe128892…`	`91768de4ddbe…`
2019-06-01 22:24 UTC · source 2019-05-30	unfinished product	product		`5b2001dcd8f5…`	`54b53d4dc9e4…`
2019-06-01 22:24 UTC · source 2019-05-30	unfinished package	package	49873-404-90	`5b2001dcd8f5…`	`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
Ingredient	Strength
DOCUSATE SODIUM	8.33 mg/1
SENNOSIDES	1.36 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
F05Q2T2JA0	Internal UNII lookup
3FYP5M0IJX	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
83c0d52b-f7e2-40b0-a01b-1ccee78f8f1b	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
49873-404-01	Sankaijo	1 in 1 CARTON	TABLET	1		11
49873-404-01	Sankaijo	150 in 1 BOTTLE	TABLET	150		11

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
docusate sodium	ACTIVE INGREDIENT	F05Q2T2JA0	SANKAIJO (DOCUSATE SODIUM, SENNOSIDES) TABLET [SATO PHARMACEUTICAL CO., LTD.]	6
SENNOSIDES	ACTIVE INGREDIENT	3FYP5M0IJX	SANKAIJO (DOCUSATE SODIUM, SENNOSIDES) TABLET [SATO PHARMACEUTICAL CO., LTD.]	6
docusate	ACTIVE MOIETY	M7P27195AG	SANKAIJO (DOCUSATE SODIUM, SENNOSIDES) TABLET [SATO PHARMACEUTICAL CO., LTD.]	6
SENNOSIDES	ACTIVE MOIETY	3FYP5M0IJX	SANKAIJO (DOCUSATE SODIUM, SENNOSIDES) TABLET [SATO PHARMACEUTICAL CO., LTD.]	6
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS	INACTIVE INGREDIENT	L11K75P92J	SANKAIJO (DOCUSATE SODIUM, SENNOSIDES) TABLET [SATO PHARMACEUTICAL CO., LTD.]	6
caramel	INACTIVE INGREDIENT	T9D99G2B1R	SANKAIJO (DOCUSATE SODIUM, SENNOSIDES) TABLET [SATO PHARMACEUTICAL CO., LTD.]	6
CARBOXYMETHYLCELLULOSE CALCIUM	INACTIVE INGREDIENT	UTY7PDF93L	SANKAIJO (DOCUSATE SODIUM, SENNOSIDES) TABLET [SATO PHARMACEUTICAL CO., LTD.]	6
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	SANKAIJO (DOCUSATE SODIUM, SENNOSIDES) TABLET [SATO PHARMACEUTICAL CO., LTD.]	6
DIMETHICONE	INACTIVE INGREDIENT	92RU3N3Y1O	SANKAIJO (DOCUSATE SODIUM, SENNOSIDES) TABLET [SATO PHARMACEUTICAL CO., LTD.]	6
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	SANKAIJO (DOCUSATE SODIUM, SENNOSIDES) TABLET [SATO PHARMACEUTICAL CO., LTD.]	6
FENNEL	INACTIVE INGREDIENT	557II4LLC3	SANKAIJO (DOCUSATE SODIUM, SENNOSIDES) TABLET [SATO PHARMACEUTICAL CO., LTD.]	6
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	SANKAIJO (DOCUSATE SODIUM, SENNOSIDES) TABLET [SATO PHARMACEUTICAL CO., LTD.]	6
HYPROMELLOSE 2910 (15000 MPA.S)	INACTIVE INGREDIENT	288VBX44JC	SANKAIJO (DOCUSATE SODIUM, SENNOSIDES) TABLET [SATO PHARMACEUTICAL CO., LTD.]	6
IPOMOEA NIL SEED	INACTIVE INGREDIENT	I85W45B4WB	SANKAIJO (DOCUSATE SODIUM, SENNOSIDES) TABLET [SATO PHARMACEUTICAL CO., LTD.]	6
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	SANKAIJO (DOCUSATE SODIUM, SENNOSIDES) TABLET [SATO PHARMACEUTICAL CO., LTD.]	6
PAEONIA SUFFRUTICOSA ROOT BARK	INACTIVE INGREDIENT	BUG255FE7X	SANKAIJO (DOCUSATE SODIUM, SENNOSIDES) TABLET [SATO PHARMACEUTICAL CO., LTD.]	6
PEG/PPG-105/5 COPOLYMER	INACTIVE INGREDIENT	52901V8XAR	SANKAIJO (DOCUSATE SODIUM, SENNOSIDES) TABLET [SATO PHARMACEUTICAL CO., LTD.]	6
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	SANKAIJO (DOCUSATE SODIUM, SENNOSIDES) TABLET [SATO PHARMACEUTICAL CO., LTD.]	6
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	SANKAIJO (DOCUSATE SODIUM, SENNOSIDES) TABLET [SATO PHARMACEUTICAL CO., LTD.]	6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
49873-404	SANKAIJO (DOCUSATE SODIUM, SENNOSIDES) TABLET [SATO PHARMACEUTICAL CO., LTD.]	11	Current NDC, Legacy NDC, 2 package rows	20231130_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 36 of 42 · 833 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Stool Softener Laxative	DOCUSATE SODIUM	United Natural Foods, Inc. dba UNFI	b1d903a5-1d5f-44d4-9939-a4b86e5a620d	2024-05-23	Warnings	Exact identifier application number: M007
Senna laxative	SENNOSIDES	United Natural Foods, Inc. dba UNFI	30b9bbf3-0a64-41de-bfb4-5c8c257cc3e8	2024-05-23	Warnings	Exact identifier application number: M007
Gentle Laxative	MAGNESIUM HYDROXIDE	MEIJER, INC.	11fe5bd0-585a-ad8a-e063-6294a90a3ae8	2024-05-22	Warnings	Exact identifier application number: M007
Stool Softener	DOCUSATE SODIUM	Sam's West, Inc	b14d2495-1092-4063-869f-73a7e8c28708	2024-05-21	Warnings	Exact identifier application number: M007
Stool Softener Plus Stimulant Laxative	DOCUSATE SODIUM AND SENNOSIDES	Safeway, Inc.	6bc9ea37-31b8-4a6d-9b2d-2c80bad4f30d	2024-05-15	Warnings	Exact identifier application number: M007
Stool Softener Plus Stimulant Laxative	DOCUSATE SODIUM AND SENNOSIDES	Safeway, Inc.	c0898583-4bbb-41d5-9e84-00cca823024f	2024-05-15	Warnings	Exact identifier application number: M007
Senna S	DOCUSATE SODIUM SENNOSIDES	QUALITY CHOICE (Chain Drug Marketing Association)	9c986ca8-d540-49c1-b092-94c1bf837c07	2024-05-09	Warnings	Exact identifier application number: M007
Fleet	GLYCERIN	C.B. Fleet Company, Inc.	381f4179-0c3b-41f8-927c-c88534ebe06d	2024-05-06	Warnings	Exact identifier application number: M007
Docusate Sodium	DOCUSATE SODIUM	NuCare Pharmaceuticals,Inc.	ed20d198-e935-200e-e053-2a95a90a309b	2024-05-02	Warnings	Exact identifier application number: M007
Sennosides, Docusate Sodium	SENNOSIDES, DOCUSATE SODIUM	Major Pharmaceuticals	1768b470-2808-fa46-e063-6394a90ac8d9	2024-05-01	Warnings	Exact identifier application number: M007
Stool Softener Stimulant laxative	DOCUSATE SODIUM AND SENNOSIDES	QUALITY CHOICE (Chain Drug Marketing Association)	9467e1f7-19bb-4fb3-853b-75c4d28bb9a9	2024-05-01	Warnings	Exact identifier application number: M007
Stool Softener Laxative	DOCUSATE SODIUM AND SENNOSIDES	QUALITY CHOICE (Chain Drug Marketing Association)	72f8e8d7-ee38-4bd3-8711-f11fded0cede	2024-05-01	Warnings	Exact identifier application number: M007
Stool Softener Laxative Extra Strength	DOCUSATE SODIUM	P & L Development, LLC	c1e9863a-c229-4694-b450-6b0e0ad37503	2024-04-30	Warnings	Exact identifier application number: M007
Stool Softener Laxative	DOCUSATE SODIUM	QUALITY CHOICE (Chain Drug Marketing Association)	96c7f8bc-be95-40d1-9977-44b7cc6582df	2024-04-22	Warnings	Exact identifier application number: M007
Pedia-Lax	MAGNESIUM HYDROXIDE	C.B. Fleet Company, Inc.	975f24d8-218c-40f4-84a5-558acf34329d	2024-04-11	Warnings	Exact identifier application number: M007
Stool Softener Laxative	DOCUSATE SODIUM AND SENNOSIDES	H E B	2f9e2723-53a7-47a8-8c41-87bffc4e50dd	2024-04-09	Warnings	Exact identifier application number: M007
Senna	SENNOSIDES	H E B	d047e4e9-b8ac-498e-9fde-8af5d415edaa	2024-04-09	Warnings	Exact identifier application number: M007
Stool Softener Laxative	DOCUSATE SODIUM	H E B	5b8bcc6c-de03-4d73-a76f-6f4c371cf250	2024-04-09	Warnings	Exact identifier application number: M007
Stool Softener	DOCUSATE SODIUM	H E B	1dd2be7e-bdca-4e43-b853-3ed10b636632	2024-04-08	Warnings	Exact identifier application number: M007
Stool Softener	DOCUSATE SODIUM	Bryant Ranch Prepack	1f11cf85-b094-4ca4-8b48-2d3a9093304b	2024-04-04	Warnings	Exact identifier application number: M007

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
F05Q2T2JA0	DOCUSATE SODIUM	577-11-7	DOCUSATE SODIUM
3FYP5M0IJX	SENNOSIDES		SENNOSIDES

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1235252	docusate sodium 8.33 MG / sennosides 1.36 MG Oral Tablet	PSN	83c0d52b-f7e2-40b0-a01b-1ccee78f8f1b	11
1235252	docusate sodium 8.33 MG / sennosides, USP 1.36 MG Oral Tablet	SCD	83c0d52b-f7e2-40b0-a01b-1ccee78f8f1b	11
1235252	DOSS Sodium 8.33 MG / sennosides, USP 1.36 MG Oral Tablet	SY	83c0d52b-f7e2-40b0-a01b-1ccee78f8f1b	11

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
49873-404-01	49873040401	1 BOTTLE in 1 CARTON (49873-404-01) / 150 TABLET in 1 BOTTLE	1 bottle	2002-12-20	0000-00-00	No	No	Current