Stool Softener Laxative

Product NDC: 0615-8557
11-digit product format: 006158557
Labeler code: 0615
Product ID: 0615-8557_90878e80-57b1-4bb3-a052-76fa593d0f67
Type: HUMAN OTC DRUG
Nonproprietary name: DOCUSATE SODIUM
Dosage form: CAPSULE, LIQUID FILLED
Route: ORAL
Labeler: NCS HealthCare of KY, LLC dba Vangard Labs
Application: M007
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2022-11-15
Substance: DOCUSATE SODIUM
Active strength: 100 mg/1
NDC exclude flag: No
Listing certified through: 2027-12-31
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	0615-8557	0615-8557-30	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 · 1 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	0615-8557	0615-8557-30	D	Discontinued by firm		excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`

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	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
4d678da0-9ada-4d00-9db9-33b45c776107	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
0615-8557-30	Stool Softener Laxative	5 in 1 BLISTER PACK	CAPSULE, LIQUID FILLED	5	3
0615-8557-30	Stool Softener Laxative	6 in 1 BOX, UNIT-DOSE	CAPSULE, LIQUID FILLED	6	3
0615-8557-39	Stool Softener Laxative	30 in 1 BLISTER PACK	CAPSULE, LIQUID FILLED	30	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0615-8557	STOOL SOFTENER LAXATIVE (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [NCS HEALTHCARE OF KY, LLC DBA VANGARD LABS]	2	Current NDC, 3 package rows	20250122_4d678da0-9ada-4d00-9db9-33b45c776107.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 41 of 42 · 833 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
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
Magnesium Citrate	MAJOR MAGNESIUM CITRATE ORAL SOLUTION - LEMON	Major Pharmaceuticals	088e5543-c947-af78-e063-6294a90a8bc4	2023-10-25	Warnings	Exact identifier application number: M007
DOK	DOCUSATE SODIUM	MAJOR PHARMACEUTICALS	7a92070d-98cc-662f-e053-2991aa0aa1b2	2023-10-23	Warnings	Exact identifier application number: M007
Stool Softener	DOCUSATE SODIUM	KROGER COMPANY	a1afaa71-7e8c-5a49-e053-2a95a90a4db0	2023-10-23	Warnings	Exact identifier application number: M007
Stool Softener	DOCUSATE SODIUM	Geri-Care Pharmaceutical Corp	644d81ec-d38f-4172-a087-727b94e2fefe	2023-10-19	Warnings	Exact identifier application number: M007
Docusate Sodium	DOCUSATE SODIUM	Asclemed USA, Inc.	30fc8c07-c26b-4bcc-a727-6e193f5727fd	2023-10-16	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	4d678da0-9ada-4d00-9db9-33b45c776107	3
1115005	docusate sodium 100 MG Oral Capsule	SCD	4d678da0-9ada-4d00-9db9-33b45c776107	3
1115005	DOSS Sodium 100 MG Oral Capsule	SY	4d678da0-9ada-4d00-9db9-33b45c776107	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
0615-8557-30	00615855730	5 in 1 BLISTER PACK				Historical
0615-8557-39	00615855739	30 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (0615-8557-39)	2024-12-11	No	No	Current