Stool Softener

Product NDC: 50804-424
11-digit product format: 508040424
Labeler code: 50804
Product ID: 50804-424_352f3947-64f9-4453-b954-e174260b93c7
Type: HUMAN OTC DRUG
Nonproprietary name: Stool Softener
Dosage form: CAPSULE, LIQUID FILLED
Route: ORAL
Labeler: Good Sense
Application: M007
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2024-06-18
Substance: DOCUSATE SODIUM
Active strength: 100 mg/1
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	50804-424	50804-424-24	D	Discontinued by firm		2026-10-20

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 · 2 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Archive	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	50804-424	50804-424-24	D	Discontinued by firm		excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	50804-424	50804-424-24	D	Discontinued by firm		excluded / ndc_excluded.zip	`f5e01cc5f278…`	`a2eaf40c39c3…`

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: 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
64266195-1b07-42c2-98a7-d76c12f74776	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
50804-424-24	Stool Softener	1 in 1 CARTON	CAPSULE, LIQUID FILLED	1	2
50804-424-24	Stool Softener	25 in 1 BOTTLE	CAPSULE, LIQUID FILLED	25	2
50804-424-25	Stool Softener	1 in 1 CARTON	CAPSULE, LIQUID FILLED	1	2
50804-424-25	Stool Softener	25 in 1 BOTTLE	CAPSULE, LIQUID FILLED	25	2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50804-424-25	EA - Each	50804-424	d2470d21-3131-480f-94ff-83e2e7b7c9e3	1	2025-08-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50804-424	STOOL SOFTENER CAPSULE, LIQUID FILLED [GOOD SENSE]	1	Current NDC, 4 package rows	20240619_64266195-1b07-42c2-98a7-d76c12f74776.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 39 of 42 · 833 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Magnesium Citrate	FRESKARO MAGNESIUM CITRATE ORAL SOLUTION - GRAPE	Pharma Nobis, LLC	f0488c86-6c74-3987-e053-2a95a90a31b4	2023-12-22	Warnings	Exact identifier application number: M007
Mineral Oil Heavy	MINERAL OIL	Pharma Nobis, LLC	e42f6c6d-c4de-02c6-e053-2995a90a3ace	2023-12-22	Warnings	Exact identifier application number: M007
Quality Choice Castor Oil	CASTOR OIL	Chain Drug Market Asociation	18d7124f-7745-45b2-adc4-cb1103add5d6	2023-12-20	Warnings	Exact identifier application number: M007
Premiere Value Castor Oil	CASTOR OIL	Chain Drug Consortium	5c8c1564-fcff-894b-e053-2991aa0a9c0b	2023-12-20	Warnings	Exact identifier application number: M007
Magnesium Citrate	BE HEALTH MAGNESIUM CITRATE ORAL SOLUTION - CHERRY	Bionpharma, Inc.	f0fa4b72-50a5-5c42-e053-2995a90a159a	2023-12-20	Warnings	Exact identifier application number: M007
Harris Teeter Castor Oil	CASTOR OIL	Harris Teeter, LLC	5cca6b4b-d88f-1c7d-e053-2991aa0a051f	2023-12-20	Warnings	Exact identifier application number: M007
Magnesium Citrate	BE HEALTH MAGNESIUM CITRATE ORAL SOLUTION - LEMON	Bionpharma, Inc.	f0f9c36e-c43b-05d2-e053-2995a90a6d65	2023-12-20	Warnings	Exact identifier application number: M007
Magnesium Citrate	BE HEALTH MAGNESIUM CITRATE ORAL SOLUTION - GRAPE	Bionpharma, Inc.	f0f9ff19-ae08-0af0-e053-2a95a90ab842	2023-12-20	Warnings	Exact identifier application number: M007
CVS Mineral Oil	MINERAL OIL	CVS	9d7402e1-524b-1084-e053-2a95a90ae3af	2023-12-20	Warnings	Exact identifier application number: M007
Top Care Castor Oil	CASTOR OIL	TOPCO ASSOCIATES LLC	8dce1a1f-e765-9c75-e053-2995a90abf9f	2023-12-18	Warnings	Exact identifier application number: M007
Humco Epson Salt	MAGNESIUM SULFATE	Humco Holding Group, Inc.	7a9d1b77-6c39-46f1-86f2-4059dde20f85	2023-12-15	Warnings	Exact identifier application number: M007
Humco Mineral Oil Heavy	MINERAL OIL	Humco Holding Group, Inc.	9f943fdf-5058-4e18-ba96-6be112bf72ca	2023-12-15	Warnings	Exact identifier application number: M007
Rite Aid Castor Oil	CASTOR OIL	Rite Aid Corporation.	5e0d3664-b01b-ba28-e053-2991aa0a8a4c	2023-12-15	Warnings	Exact identifier application number: M007
GNP Castor Oil	CASTOR OIL	Amerisource Bergen	5d06bec6-f1e7-4f0c-e053-2991aa0a8ad8	2023-12-14	Warnings	Exact identifier application number: M007
Sankaijo	DOCUSATE SODIUM, SENNOSIDES	Sato Pharmaceutical Co., Ltd.	83c0d52b-f7e2-40b0-a01b-1ccee78f8f1b	2023-11-29	Warnings	Exact identifier application number: M007
SIMPEX Bisacodyl laxative	BISACODYL	Simpex Pharma Pvt. Ltd	5114ed64-4fec-401b-8a91-8df3e42b10b1	2023-11-29	Warnings	Exact identifier application number: M007
Stool Softener	DOCUSATE SODIUM	Geri-Care Pharmaceutical Corp	b595063a-5fee-18c2-e053-2a95a90a5b99	2023-11-15	Warnings	Exact identifier application number: M007
MILK OF MAGNESIA	MAGNESIUM HYDROXIDE	Publix	cbf7dcef-7623-b333-e053-2a95a90a0f1a	2023-11-08	Warnings	Exact identifier application number: M007
MILK OF MAGNESIA	MAGNESIUM HYDROXIDE	Meijer, Inc.	bb8b51e9-ba4a-270d-e053-2a95a90a318b	2023-11-08	Warnings	Exact identifier application number: M007
MILK OF MAGNESIA	MAGNESIUM HYDROXIDE	STRATEGIC SOURCING SERVICES LLC	ff0d4b9f-7ce8-dd98-e053-6394a90ab614	2023-11-08	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	64266195-1b07-42c2-98a7-d76c12f74776	2
1115005	docusate sodium 100 MG Oral Capsule	SCD	64266195-1b07-42c2-98a7-d76c12f74776	2
1115005	DOSS Sodium 100 MG Oral Capsule	SY	64266195-1b07-42c2-98a7-d76c12f74776	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
50804-424-24	50804042424	1 in 1 CARTON					Historical
50804-424-25	50804042425	1 BOTTLE in 1 CARTON (50804-424-25) / 25 CAPSULE, LIQUID FILLED in 1 BOTTLE	1 bottle	2024-06-18	No	No	Current