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		2026-10-16

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 27 of 42 · 833 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Bisacodyl	BISACODYL SUPPOSITORIES	Oncor Pharmaceuticals	6f0aefc9-cd5f-4bdd-89c2-b6a80558987c	2025-01-24	Warnings	Exact identifier application number: M007
Stool Softener Laxative	DOCUSATE SODIUM	NuCare Pharmaceuticals, Inc.	2c65319f-6cf5-aa90-e063-6394a90ad662	2025-01-23	Warnings	Exact identifier application number: M007
Epsom Salt	MAGNESIUM SULFATE	Cardinal Health (Leader) 70000	cde87f95-73c0-46f5-9349-37e04096048c	2025-01-22	Warnings	Exact identifier application number: M007
Senna-Tabs	SENNA 8.6MG	Ulai Health LLC	485129a0-8340-4f61-be51-5abff5032b8d	2025-01-20	Warnings	Exact identifier application number: M007
Fiber Laxative	CALCIUM POLYCARBOPHIL	Topco Associates, LLC	0609468d-ee66-49af-be40-e51965b88f6f	2025-01-20	Warnings	Exact identifier application number: M007
Soluble Fiber	METHYLCELLULOSE	United Natural Foods, Inc. dba UNFI	6decd5ef-e8e1-44ae-8465-6266cf18e81e	2025-01-20	Warnings	Exact identifier application number: M007
Perdiem	SENNOSIDES, STIMULANT LAXATIVE	Haleon US Holdings LLC	6b256c8f-3953-4c69-9a16-ffa0511bdbcd	2025-01-16	Warnings	Exact identifier application number: M007
Senna Syrup	SENNOSIDES	Everpharm LLC	0ea9f2b5-4533-4b71-b019-10ecb3c06459	2025-01-16	Warnings	Exact identifier application number: M007
Anecream 5	LIDOCAINE 5%	Focus Health Group	1810edc3-093e-402f-bcb0-9c731da283a7	2025-01-15	Warnings	Exact identifier application number: M007
Senna	SENNOSIDES	Reliable 1 Laboratories LLC	ae46a611-20f2-74c8-e053-2995a90a32ce	2025-01-15	Warnings	Exact identifier application number: M007
Sennosides and Docusate Sodium	SENNOSIDES, DOCUSATE SODIUM	Reliable-1 Laboratories LLC	a97a1829-f62f-2014-e053-2a95a90a8cc5	2025-01-15	Warnings	Exact identifier application number: M007
Stool Softener Laxative	DOCUSATE SODIUM	NCS HealthCare of KY, LLC dba Vangard Labs	4d678da0-9ada-4d00-9db9-33b45c776107	2025-01-15	Warnings	Exact identifier application number: M007 ndc (product): 0615-8557
Goodsense Fiber laxative 147	CALCIUM POLYCARBOPHIL	GoodSense	17f5570b-be85-9dce-e063-6294a90abeaf	2025-01-14	Warnings	Exact identifier application number: M007
Sunmark Mineral Oil Laxative	MINERAL OIL	Strategic Sourcing Services	c54f7df2-3845-425f-b13e-3dc000123f3c	2025-01-14	Warnings	Exact identifier application number: M007
Senna-S	SENNOSIDES 8.6MG AND DOCUSATE SODIUM 50MG	Ulai Health LLC	c0e27b02-8ef2-4239-8f8c-790f7d978dc0	2025-01-12	Warnings	Exact identifier application number: M007
Docusate Sodium	DOCUSATE SODIUM	Major Pharmaceuticals	1541ff5b-11f8-444b-a2a0-8e3086ae650a	2025-01-10	Warnings	Exact identifier application number: M007
Docusate Sodium	DOCUSATE SODIUM	AvPAK	f31a4349-7826-45c0-9388-6b938d167b7a	2025-01-09	Warnings	Exact identifier application number: M007
Docusate sodium	DOCUSATE SODIUM	APNAR PHARMA LP	05b0732b-012f-78ee-e063-6294a90a839a	2025-01-09	Warnings	Exact identifier application number: M007
Foster and Thrive Ready to Use Saline Laxative	SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM AND SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM	McKesson	e5fdfcfd-5340-4929-9f68-2696110cca8e	2025-01-07	Warnings	Exact identifier application number: M007
Calcium Polycarbophil	CALCIUM POLYCARBOPHIL	SHANDONG XINHUA PHARMACEUTICAL CO., LTD.	ee06868b-f741-8da2-e053-2a95a90a9772	2025-01-02	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