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		2026-10-15

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 7 of 42 · 833 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Sennosides, Docusate Sodium	SENNOSIDES, DOCUSATE SODIUM	Cardinal Health 107, LLC	1a21b07a-263c-41a4-ba0c-ad2dc5a295d7	2026-05-05	Warnings	Exact identifier application number: M007
Docusate Sodium and Sennosides	DOCUSATE SODIUM AND SENNOSIDES	SOFTGEL HEALTHCARE PRIVATE LIMITED	4842a767-bb12-9d85-e063-6294a90a19b5	2026-04-27	Warnings	Exact identifier application number: M007
Alcohol wet wipes	ALCOHOL WET WIPES	Shandong Aishule Hygiene Products Co., Ltd	f79dbac0-cec0-46bc-e053-6294a90a2b13	2026-04-25	Warnings	Exact identifier application number: M007
Sterilized wet wipes	STERILIZED WET WIPES	Shandong Aishule Hygiene Products Co., Ltd	f7ca1799-eee4-66f0-e053-6294a90a273f	2026-04-25	Warnings	Exact identifier application number: M007
Wet wipes	WET WIPES	JINGXIN GROUP (M) SDN BHD	395225b1-486b-1867-e063-6394a90a1865	2026-04-25	Warnings	Exact identifier application number: M007
Sterilized wet wipes	STERILIZED WET WIPES	JINGXIN GROUP (M) SDN BHD	3952873e-5e3f-1bff-e063-6294a90a8a62	2026-04-25	Warnings	Exact identifier application number: M007
Stool Softener Laxative	DOCUSATE SODIUM	Publix Supermarkets, Inc.	ed50555f-b105-45c8-9dc4-1bd4d233a1e3	2026-04-23	Warnings	Exact identifier application number: M007
Mineral Oil	MINERAL OIL	Publix Supermarkets, Inc.	382a57d1-85bf-480f-9967-f85da2904410	2026-04-23	Warnings	Exact identifier application number: M007
BISACODYL	BISACODYL	AARNA USA INC.	50109967-69af-5fc5-e063-6394a90a8751	2026-04-22	Warnings	Exact identifier application number: M007
Senna	SENNA	Rugby Laboratories	41d53783-7ac2-411c-b9bf-afd87b3af30d	2026-04-18	Warnings	Exact identifier application number: M007
Stool Softener Laxative	DOCUSATE SODIUM	United Natural Foods, Inc. dba UNFI	95bae7bf-f240-4674-9e3c-640a603fdc35	2026-04-15	Warnings	Exact identifier application number: M007
Magnesium Citrate	MAGNESIUM CITRATE	Publix Super Markets, Inc.	a4b442f1-d5a6-4cbf-b371-1f6639634f80	2026-04-13	Warnings, Adverse reactions	Exact identifier application number: M007
Magnesium Citrate	MAGNESIUM CITRATE	Publix Super Markets, Inc.	267c434d-3034-491b-b4b1-1d0cbacb1615	2026-04-13	Warnings, Adverse reactions	Exact identifier application number: M007
Stool Softener Laxative	DOCUSATE SODIUM	Bryant Ranch Prepack	d616685a-11fc-4ae0-80de-7d25c0d71ee9	2026-04-09	Warnings	Exact identifier application number: M007
Stool Softener Laxative	DOCUSATE SODIUM	H E B	84116db2-a7b7-460a-a5e5-8558bd424781	2026-04-02	Warnings	Exact identifier application number: M007
MILK OF MAGNESIA ORIGINAL	MAGNESIUM HYDROXIDE	American Health Packaging	7d7d789b-b2e7-4600-a025-0cd2ff5b3672	2026-04-02	Warnings	Exact identifier application number: M007
Castor Oil	CASTOR OIL	STRATEGIC SOURCING SERVICES	4db6736f-416a-f142-e063-6394a90ab08f	2026-04-01	Warnings	Exact identifier application number: M007
Magnesium Citrate	MAGNESIUM CITRATE	Farmacias De Similares TX LLC	4e6a64a0-e453-709b-e063-6294a90a7443	2026-04-01	Warnings	Exact identifier application number: M007
Stool Softener Laxative	DOCUSATE SODIUM	Major Pharmaceuticals	93ef6486-0930-41e3-a2c6-44af7e37e98b	2026-03-31	Warnings	Exact identifier application number: M007
Senna Syrup	NATURAL VEGETABLE LAXATIVE	Bryant Ranch Prepack	2c0d62e7-563b-46e4-9793-183e98e761a6	2026-03-25	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