Quality Choice Stool Softener

Product NDC: 63868-585
11-digit product format: 638680585
Labeler code: 63868
Product ID: 63868-585_129ab8f7-316a-4106-8f58-17015db9c661
Type: HUMAN OTC DRUG
Nonproprietary name: DOCUSATE SODIUM
Dosage form: CAPSULE, LIQUID FILLED
Route: ORAL
Labeler: Chain Drug Marketing Association
Application: M007
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2020-11-11
Substance: DOCUSATE SODIUM
Active strength: 100 mg/1
NDC exclude flag: No
Listing certified through: 2026-12-31
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: Quality Choice Stool Softener
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DOCUSATE SODIUM	100 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

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

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1115005	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
4d5facd4-f57f-44f7-b8dd-83a33e57afd9	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
63868-585-01	Quality Choice Stool Softener	100 in 1 BOTTLE	CAPSULE, LIQUID FILLED	100		3
63868-585-25	Quality Choice Stool Softener	250 in 1 BOTTLE	CAPSULE, LIQUID FILLED	250		3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63868-585-01	EA - Each	63868-585	5c402a9c-cd07-4be0-95c0-ea2a2629914e	1	2022-08-04
63868-585-25	EA - Each	63868-585	9fba97b2-9da9-4581-83f3-3b13ef2b6b0a	1	2022-09-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63868-585	QUALITY CHOICE STOOL SOFTENER (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [CHAIN DRUG MARKETING ASSOCIATION]	3	Current NDC, Legacy NDC, 2 package rows	20241220_4d5facd4-f57f-44f7-b8dd-83a33e57afd9.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 · 829 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
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
Stool Softener Laxative	DOCUSATE SODIUM	TARGET Corporation	89106733-69f1-469b-9d07-f06ac09b2fb6	2024-04-02	Warnings	Exact identifier application number: M007
Stool Softener Laxative Plus Stimulant	DOCUSATE SODIUM AND SENNOSIDES	Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)	89dc2063-6744-4412-89be-90990090b57c	2024-03-19	Warnings	Exact identifier application number: M007
Senna Laxative	SENNOSIDES	Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)	2322765d-6f08-48d4-a500-818a8a558f6f	2024-03-19	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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1115005	docusate sodium 100 MG Oral Capsule	PSN	4d5facd4-f57f-44f7-b8dd-83a33e57afd9	3
1115005	docusate sodium 100 MG Oral Capsule	SCD	4d5facd4-f57f-44f7-b8dd-83a33e57afd9	3
1115005	DOSS Sodium 100 MG Oral Capsule	SY	4d5facd4-f57f-44f7-b8dd-83a33e57afd9	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
63868-585-01	63868058501	100 CAPSULE, LIQUID FILLED in 1 BOTTLE (63868-585-01)	2020-11-11	0000-00-00	No	No	Current
63868-585-25	63868058525	250 CAPSULE, LIQUID FILLED in 1 BOTTLE (63868-585-25)	2020-11-11	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
DOCUSATE SODIUM 100mg Two-Tone, Capsule, liquid filled	Chain Drug Marketing Association \| Reese Pharmaceutical \| Swiss Caps Romania	2024-12-18	HUMAN OTC DRUG LABEL	3