Stool Softener Laxative

Product NDC: 63868-946
11-digit product format: 638680946
Labeler code: 63868
Product ID: 63868-946_866fb276-b4fd-4634-b66e-38a6b29bb980
Type: HUMAN OTC DRUG
Nonproprietary name: docusate sodium and sennosides
Dosage form: TABLET
Route: ORAL
Labeler: QUALITY CHOICE (Chain Drug Marketing Association)
Application: M007
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2021-03-31
Substance: DOCUSATE SODIUM; SENNOSIDES
Active strength: 50; 8.6 mg/1; mg/1
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

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: Stool Softener Laxative
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DOCUSATE SODIUM	50 mg/1
SENNOSIDES	8.6 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
998740	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
72f8e8d7-ee38-4bd3-8711-f11fded0cede	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
63868-946-01	Stool Softener Laxative	100 in 1 BOTTLE, PLASTIC	TABLET	100		5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63868-946	STOOL SOFTENER LAXATIVE (DOCUSATE SODIUM AND SENNOSIDES) TABLET [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]	5	Current NDC, Legacy NDC, 1 package rows	20240502_72f8e8d7-ee38-4bd3-8711-f11fded0cede.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 34 of 41 · 817 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Stool Softener Laxative Plus Stimulant	DOCUSATE SODIUM AND SENNOSIDES	Walgreens	db528659-768a-46e0-a340-9fbcdb25ea5e	2024-07-25	Warnings	Exact identifier application number: M007
Senna laxative	SENNOSIDES	Walgreens	bfa089a6-4767-45e0-b663-ee7e8949d9a4	2024-07-25	Warnings	Exact identifier application number: M007
Dr. Fibra	PSYLLIUM HUSK	Pharmadel LLC	1a6151c9-e1c4-f0c1-e063-6394a90aad24	2024-07-22	Warnings	Exact identifier application number: M007
BISACODYL	BISCODYL	TARGET CORPORATION	8ed281d5-b17e-e3bb-e053-2995a90a2590	2024-07-15	Warnings	Exact identifier application number: M007
Stool Softener	DOCUSATE CALCIUM	Walgreens	b6f0770e-671d-4965-9275-b1c224d7f06a	2024-07-10	Warnings	Exact identifier application number: M007
Stool Softener	DOCUSATE SODIUM	Bryant Ranch Prepack	2c9a1fe7-b77b-436b-8701-9f95f642d001	2024-07-05	Warnings	Exact identifier application number: M007
SENNA	SENNA	Precision Dose, Inc.	e637777e-a39d-4e2f-a95c-4f524aa122f7	2024-07-05	Warnings	Exact identifier application number: M007
Gentle Laxative	MAGNESIUM HYDROXIDE	GERI-CARE PHARMACEUTICALS, CORP	1c462af8-af1a-391c-e063-6394a90a8b49	2024-07-02	Warnings	Exact identifier application number: M007
Good Neighbor Pharmacy Fiber-Caps Fiber Laxative Stimulant Free	CALCIUM POLYCARBOPHIL	Amerisourcebergen Drug Corporation	4911fb44-e070-46c1-8f90-b78ceb10e51e	2024-06-28	Warnings	Exact identifier application number: M007
Fleet	DOCUSATE SODIUM	C.B. Fleet Company, Inc.	56a7b6c5-d674-4eed-91c2-77f7d18fff32	2024-06-27	Warnings	Exact identifier application number: M007
Stool Softener Laxative Extra Strength	DOCUSATE SODIUM	WALMART INC. (see also Equate)	2cf6c9bf-c318-445d-9306-5675b1d424b0	2024-06-26	Warnings	Exact identifier application number: M007
Stool Softener Laxative	DOCUSATE SODIUM	WALMART INC. (see also Equate)	d9db24b5-e3b5-47f9-b86b-bc8d70896a11	2024-06-26	Warnings	Exact identifier application number: M007
Stool Softener	DOCUSATE CALCIUM	Walgreens	2791223a-7ac0-47e5-9a6a-4d9a02cfeb63	2024-06-25	Warnings	Exact identifier application number: M007
Fleet	BISACODYL	C.B. Fleet Company, Inc.	4e0d973f-e6dc-48d9-8df3-1d47c87840f1	2024-06-21	Warnings	Exact identifier application number: M007
Stool Softener Plus Stimulant Laxative	DOCUSATE SODIUM AND SENNOSIDES	TOP CARE (Topco Associates LLC)	3b184800-649b-45d0-9586-8055d6d7fe08	2024-06-20	Warnings	Exact identifier application number: M007
Senna Laxative	SENNA LAXATIVE	Good Sense	9393032e-4343-4ac5-8e91-36013e5ca089	2024-06-18	Warnings	Exact identifier application number: M007
Stool Softener	STOOL SOFTENER	Good Sense	64266195-1b07-42c2-98a7-d76c12f74776	2024-06-18	Warnings	Exact identifier application number: M007
Stool Softener Plus Stimulant	DOCUSATE SODIUM AND SENNOSIDES	United Natural Foods, Inc. dba UNFI	6c8c7c46-3ded-4e89-8e16-30eeb72aa08b	2024-06-14	Warnings	Exact identifier application number: M007
Stool Softener Plus Stimulant Laxative	DOCUSATE SODIUM AND SENNOSIDES	United Natural Foods, Inc. dba UNFI	50ca1ce2-885f-4b71-a5fb-90c2cf508ce6	2024-06-14	Warnings	Exact identifier application number: M007
basic care stool softener	DOCUSATE SODIUM	Amazon.com Services LLC	356a889f-ec23-4eb2-a25c-bbe609475155	2024-06-14	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
998740	sennosides 8.6 MG / docusate sodium 50 MG Oral Tablet	PSN	72f8e8d7-ee38-4bd3-8711-f11fded0cede	5
998740	docusate sodium 50 MG / sennosides, USP 8.6 MG Oral Tablet	SCD	72f8e8d7-ee38-4bd3-8711-f11fded0cede	5
998740	DOSS Sodium 50 MG / sennosides, USP 8.6 MG Oral Tablet	SY	72f8e8d7-ee38-4bd3-8711-f11fded0cede	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
63868-946-01	63868094601	100 TABLET in 1 BOTTLE, PLASTIC (63868-946-01)	100 tablet	2021-03-31	0000-00-00	No	No	Current