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: 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	0615-8557	0615-8557-30	D	Discontinued by firm		2026-08-17

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…`

Additional Listing Data#

Finished product: Yes
Brand name base: Stool Softener Laxative
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
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 1 of 44 · 874 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Epsom Salt	MAGNESIUM SULFATE	Cardinal Health, 110 dba Leader	d27dc1cc-5e17-40d3-84fe-c1792552cfd5	2026-08-25	Warnings, Adverse reactions	Exact identifier application number: M007
Stool Softener Laxative	DOCUSATE SODIUM	Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)	ccec364a-3135-4a5d-b4b0-86b832387b4e	2026-08-24	Warnings	Exact identifier application number: M007
Colace	DOCUSATE SODIUM	Atlantis Consumer Healthcare, Inc.	a1591da0-a1a9-9583-3cf5-788b8fee3814	2026-08-24		Exact identifier application number: M007
MiraFAST soft chews	MAGNESIUM HYDROXIDE	Bayer HealthCare LLC.	2cee67dd-b71f-32b8-e063-6394a90ae864	2026-08-21	Warnings	Exact identifier application number: M007
Senokot-S	STANDARDIZED SENNA CONCENTRATE AND DOCUSATE SODIUM	Atlantis Consumer Healthcare, Inc.	c24cdc5e-62e0-41a6-8afb-512202a569f4	2026-08-21	Warnings	Exact identifier application number: M007
Epsom Salt	EPSOM SALT	AmerisourceBergen (Good Neighbor Pharmacy) 46122	d22fb02f-09c4-476a-b6d6-d3a2fd30049d	2026-08-18	Warnings	Exact identifier application number: M007
CVS Stool Softener Fruit Punch	DOCUSATE SODIUM	CVS PHARMACY, INC	0e6900d6-7dc9-47d6-a006-1695feb8d5a5	2026-08-17	Warnings	Exact identifier application number: M007
CVS Senna Laxative	SENNOSIDES	CVS PHARMACY	5a5565b2-827f-4fcc-a835-d827f62da8f9	2026-08-17	Warnings	Exact identifier application number: M007
Stool Softener Laxative	DOCUSATE SODIUM	Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)	306fd12b-ed60-40dc-a5be-2dc394bd29d2	2026-08-17	Warnings	Exact identifier application number: M007
CVS Health Childrens Saline Laxative	MAGNESIUM HYDROXIDE	CVS PHARMACY,INC.	e57e5529-2190-4c66-8397-bc2848739e59	2026-08-14	Warnings	Exact identifier application number: M007
Docusate Sodium and Sennosides	DOCUSATE SODIUM AND SENNOSIDES	Morepen Bio Inc	562d1b9a-09d8-92fc-e063-6394a90a1993	2026-08-14	Warnings	Exact identifier application number: M007
CVS Health	NATURAL FIBER SUPPLEMENT	CVS Pharmacy,Inc.	04dbe9aa-ed18-4d76-a840-d010445a8643	2026-08-14	Warnings	Exact identifier application number: M007
CVS Fiber Therapy	METHYLCELLULOSE	CVS PHARMACY	e066f5bd-5f34-4e04-beec-3c7d6db49381	2026-08-13	Warnings	Exact identifier application number: M007
Mineral oil	MINERAL OIL	EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)	92f2147d-b52d-4282-b217-28f6095dca0e	2026-08-12	Warnings	Exact identifier application number: M007
CAREONE Orange Flavored	PSYLLIUM HUSK	FOODHOLD USA	4b1cccd2-e941-4d51-9924-4ca35e3a4429	2026-08-11	Warnings	Exact identifier application number: M007
CAREONE	PSYLLIUM HUSK	FOODHOLD USA	3ec3ead0-382e-4765-bbe8-b21e7c7b42a6	2026-08-11	Warnings	Exact identifier application number: M007
Stool Softener	DOCUSATE SODIUM	Dolgencorp, Inc. (DOLLAR GENERAL & REXALL)	f4671579-aed0-4f93-ab83-248e0d72b5b0	2026-08-10	Warnings	Exact identifier application number: M007
Docusate Sodium Liquid	DOCUSATE SODIUM.50MG/5ML	Aldama Pharmaceuticals, Inc	492b6d37-47cf-3a28-e063-6294a90a2a18	2026-08-10	Warnings	Exact identifier application number: M007
Epsom Salt	MAGNESIUM SULFATE	Safeway Inc	0b757160-f9eb-4413-9b43-97544c49c72f	2026-08-10	Warnings, Adverse reactions	Exact identifier application number: M007
Sennosides	SENNOSIDES	Cardinal Health 107, LLC	4a9e1cbe-ffe4-462f-a86d-078a357dcf49	2026-08-07	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