STOOL SOFTENER

Product NDC: 57896-421
11-digit product format: 578960421
Labeler code: 57896
Product ID: 57896-421_548956c0-c6c7-be65-e063-6294a90a44fe
Type: HUMAN OTC DRUG
Nonproprietary name: docusate sodium
Dosage form: TABLET
Route: ORAL
Labeler: Geri-Care Pharmaceuticals, Corp
Application: M007
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2015-09-01
Substance: DOCUSATE SODIUM
Active strength: 100 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
Listing expiration: 2027-12-31

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
1099279	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
3ec42148-6786-22f2-e054-00144ff8d46c	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
57896-421-01	STOOL SOFTENER	100 in 1 BOTTLE	TABLET	100	5
57896-421-10	STOOL SOFTENER	1000 in 1 BOTTLE	TABLET	1000	5
57896-421-20	STOOL SOFTENER	200 in 1 BOTTLE	TABLET	200	5

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
57896-421-01	EA - Each	57896-421	81c968a7-8921-4237-8518-0aea0336f8ed	1	2016-11-08
57896-421-10	EA - Each	57896-421	3f2e704c-f32c-409c-b2b9-3587365c5f1d	1	2016-11-08
57896-421-20	EA - Each	57896-421	f0110dec-7b8d-45b9-a166-56a71b6ddde2	1	2022-03-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
57896-421	STOOL SOFTENER (DOCUSATE SODIUM) TABLET [GERI-CARE PHARMACEUTICALS, CORP]	5	Current NDC, Legacy NDC, 3 package rows	20241218_3ec42148-6786-22f2-e054-00144ff8d46c.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 23 of 43 · 858 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Castor Oil	CASTOR OIL	BIONPHARMA INC.	3f9728e8-c7a2-6cfb-e063-6394a90a8f1d	2025-10-06	Warnings	Exact identifier application number: M007
Epsom Salt	MAGNESIUM SULFATE	Family Dollar (FAMILY WELLNESS)	7de802aa-6c31-451c-995c-8549b2545c69	2025-10-06	Warnings	Exact identifier application number: M007
Sennosides	SENNOSIDES	InvaTech Pharma Solutions LLC	3de39fbd-29be-fce7-e063-6394a90a67ae	2025-10-03	Warnings	Exact identifier application number: M007
Metamucil Therapy for regularity	PSYLLIUM HUSK	The Procter & Gamble Manufacturing Company	a9824f73-5ea2-4a65-a926-3a57561441b8	2025-10-01	Warnings	Exact identifier application number: M007
OneLAX SENNA	SENNA	Atlantic Biologicals Corp.	40202c76-4273-88fd-e063-6394a90a07b2	2025-10-01	Warnings	Exact identifier application number: M007
Magnesium Citrate	MAGNESIUM CITRATE ORAL SOLUTION	Bionpharma, Inc.	4019fbd0-fcf9-77a6-e063-6294a90a5ae7	2025-09-30	Warnings	Exact identifier application number: M007
LEADER HYDROCORTISONE WITH ALOE	HYDROCORTISONE	LEADER	39916470-15bf-4bd0-96e2-b909d68cf9c4	2025-09-29	Warnings	Exact identifier application number: M007
Leader Ready to Use Mineral Oil Laxative	MINERAL OIL	Cardinal Health	b8494d02-8a7d-47b4-80b0-b8ab51b625fd	2025-09-29	Warnings	Exact identifier application number: M007
Leader Ready to Use Saline Laxative	SODIUM PHOSPHATE, DIBASIC AND SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM	Cardinal Health	1b4f9c28-0547-4922-aa15-990c6fd9dc9f	2025-09-29	Warnings	Exact identifier application number: M007
Milk of Magnesia	MAGNESIUM HYDROXIDE	Kesin Pharma Corporation	3f7cff50-749b-5275-e063-6394a90af407	2025-09-23	Warnings	Exact identifier application number: M007
Stimulant Laxative Plus Stool Softener	DOCUSATE SODIUM 50 MG AND SENNOSIDES 8.6 MG	Bryant Ranch Prepack	12f613e4-c919-4cc4-a445-eb30039ae45f	2025-09-18	Warnings	Exact identifier application number: M007
Saline Laxative	SALINE LAXATIVE	Major Pharmaceuticals	b3758ffe-1bac-4df6-9714-5e33e9d28d90	2025-09-16	Warnings	Exact identifier application number: M007
Gentle Laxative	BISACODYL	BETTER LIVING BRANDS LLC.	f29d57f6-0938-d459-e053-2995a90ad86b	2025-09-13	Warnings	Exact identifier application number: M007
Epsom Salt	MAGNESIUM SULFATE	Walgreens	7365e199-5038-48eb-b0b9-7b46f9894dd7	2025-09-05	Warnings	Exact identifier application number: M007
MILK OF MAGNESIA	MAGNESIUM HYDROXIDE	H E B	ab995d9a-1e40-2b38-e053-2a95a90a87e4	2025-08-21	Warnings	Exact identifier application number: M007
Senokot	STANDARDIZED SENNA CONCENTRATE	Atlantis Consumer Healthcare, Inc.	d5bf67e5-82c6-edbf-e9ec-e027fdd47c84	2025-08-20	Warnings	Exact identifier application number: M007
Stool Softener	DOCUSATE SODIUM	BJWC (Berkley & Jensen / BJ's)	330758d2-fc1a-50ce-e063-6294a90a7db1	2025-08-19	Warnings	Exact identifier application number: M007
Sennosides and Docusate Sodium	SENNOSIDES AND DOCUSATE SODIUM	American Health Packaging	4b84d5d7-43cf-47bb-af59-088550c3a0bc	2025-08-12	Warnings	Exact identifier application number: M007
Stool Softener Laxative	DOCUSATE SODIUM	Good Sense (Geiss, Destin & Dunn, Inc.)	8066a52d-e683-47c1-905c-290d2d427acf	2025-08-12	Warnings	Exact identifier application number: M007
Prolaxa	DOCUSATE SODIUM 250MG	Advanced Rx of Tennessee, LLC	3ba0c0d9-9e6f-a2e6-e063-6394a90a202d	2025-08-05	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
1099279	docusate sodium 100 MG Oral Tablet	PSN	3ec42148-6786-22f2-e054-00144ff8d46c	5
1099279	docusate sodium 100 MG Oral Tablet	SCD	3ec42148-6786-22f2-e054-00144ff8d46c	5
1099279	DOSS Sodium 100 MG Oral Tablet	SY	3ec42148-6786-22f2-e054-00144ff8d46c	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
57896-421-01	57896042101	100 TABLET in 1 BOTTLE (57896-421-01)	100 tablet	2015-09-01	0000-00-00	No	No	Current
57896-421-10	57896042110	1000 TABLET in 1 BOTTLE (57896-421-10)	1000 tablet	2015-09-01	0000-00-00	No	No	Current
57896-421-20	57896042120	200 TABLET in 1 BOTTLE (57896-421-20)	200 tablet	2019-05-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Gericare 421	Geri-Care Pharmaceuticals, Corp \| GCP Laboratories	2026-06-18	HUMAN OTC DRUG LABEL	6