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 42 of 43 · 858 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
MILK OF MAGNESIA	MAGNESIUM HYDROXIDE	TOP CARE (TOPCO ASSOCIATES LLC)	b83eb807-d522-4408-e053-2a95a90a7926	2023-11-07	Warnings	Exact identifier application number: M007
MILK OF MAGNESIA CHERRY	MAGNESIUM HYDROXIDE	TOP CARE (TOPCO ASSOCIATES LLC)	b83f0c1c-0e90-2888-e053-2995a90a0b96	2023-11-07	Warnings	Exact identifier application number: M007
MILK OF MAGNESIA	MAGNESIUM HYDROXIDE	DOLGENCORP, INC.	b6991abf-9819-701c-e053-2a95a90ac0b4	2023-11-07	Warnings	Exact identifier application number: M007
MILK OF MAGNESIA MINT	MAGNESIUM HYDROXIDE	Chain Drug Marketing Association	7722145c-913c-4ed5-a9b2-a6c343064066	2023-11-06	Warnings	Exact identifier application number: M007
MILK OF MAGNESIA CHERRY	MAGNESIUM HYDROXIDE	Chain Drug Marketing Association	12361478-d178-4950-9458-4e2e56565599	2023-11-06	Warnings	Exact identifier application number: M007
MILK OF MAGNESIA	MAGNESIUM HYDROXIDE	Wal-Mart Stores, Inc.	750e0355-369e-b679-e053-2a91aa0a66ca	2023-11-01	Warnings	Exact identifier application number: M007
MILK OF MAGNESIA	MAGNESIUM HYDROXIDE	Wal-Mart Stores, Inc.	750efd58-5845-fbc4-e053-2a91aa0a86d1	2023-11-01	Warnings	Exact identifier application number: M007
Gentle Laxative	MAGNESIUM HYDROXIDE	WALGREEN COMPANY	ba4a29b3-2ddc-b906-e053-2995a90a2ab7	2023-11-01	Warnings	Exact identifier application number: M007
DOCUZEN	SENNOSIDES 8.6MG AND DOCUSATE SODIUM 50MG	Proficient Rx LP	92879e62-f60a-4ab4-9532-610cdd2628ee	2023-11-01	Warnings	Exact identifier application number: M007
Docusate Sodium	DOCUSATE SODIUM	A-S Medication Solutions	5999904a-6ac8-4d9e-951c-6e64e8cd93eb	2023-11-01	Warnings	Exact identifier application number: M007
MILK OF MAGNESIA	MAGNESIUM HYDROXIDE	VALU MERCHANDISERS COMPANY	5e98f9d9-679c-63a2-e053-2991aa0a4b8d	2023-10-31	Warnings	Exact identifier application number: M007
MILK OF MAGNESIA	MAGNESIUM HYDROXIDE	VALU MERCHANDISERS COMPANY	5e957b01-4f44-0a2a-e053-2991aa0a37a0	2023-10-31	Warnings	Exact identifier application number: M007
MILK OF MAGNESIA	MAGNESIUM HYDROXIDE	VALU MERCHANDISERS COMPANY	5e993b13-8dc8-6653-e053-2a91aa0a4c2a	2023-10-31	Warnings	Exact identifier application number: M007
MILK OF MAGNESIA	MAGNESIUM HYDROXIDE	CVS	3c8e4144-6702-2678-e054-00144ff88e88	2023-10-31	Warnings	Exact identifier application number: M007
Fiber Laxative	CALCIUM POLYCARBOPHIL	Magno-Humphries, Inc.	9d22c208-d089-8b6a-e053-2995a90ab90a	2023-10-27	Warnings	Exact identifier application number: M007
Stool Softener Docusate Sodium	DOCUSATE SODIUM	Magno-Humphries, Inc.	a0e6ab9b-fd31-45fd-93d5-b51d705c180a	2023-10-27	Warnings	Exact identifier application number: M007
Sennosides Natural Laxative	SENNOSIDES	Magno-Humphries, Inc.	9d22bedb-9fca-8421-e053-2a95a90acf4a	2023-10-27	Warnings	Exact identifier application number: M007
Stool Softener Docusate Sodium	DOCUSATE SODIUM	Magno-Humphries, Inc.	9d22d642-8aed-d17e-e053-2995a90ae182	2023-10-27	Warnings	Exact identifier application number: M007
Senna S	DOCUSATE SODIUM, SENNOSIDES	Magno-Humphries, Inc.	9deaf264-6af0-40ba-e053-2a95a90ada0e	2023-10-27	Warnings	Exact identifier application number: M007
FLEET	MINERAL OIL	C.B. Fleet Company, Inc.	2528cb5e-437e-41f0-9c34-e9ce57404d8b	2023-10-26	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