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 5 of 42 · 833 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
MILK OF MAGNESIA MINT	MAGNESIUM HYDROXIDE	Preferred Pharmaceuticals Inc.	f8bba8cb-a111-4285-8bdb-2273a049c3bb	2026-07-08	Warnings	Exact identifier application number: M007
DOCUSATE SODIUM, EXTRA STRENGTH 250 MG	DOCUSATE SODIUM	Advanced Rx LLC	fc8cf24e-8ca1-b3fb-e053-6294a90a7a50	2026-07-06	Warnings	Exact identifier application number: M007
Curewell Docusate Sodium Liquid	DOCUSATE SODIUM.50MG/5ML	RMT HEALTH LLC	55903043-2a1d-0525-e063-6394a90ae182	2026-07-01	Warnings	Exact identifier application number: M007
Senna	SENNOSIDES 8.6 MG TABLETS	Aarkish Pharmaceuticals NJ Inc.	564bc9a5-13b5-4cce-a349-6b2e122683ed	2026-07-01	Warnings	Exact identifier application number: M007
Senna-S	DOCUSATE SODIUM 50 MG SENNOSIDES 8.6 MG	Aarkish Pharmaceuticals NJ Inc.	faca8f3e-d9eb-44c5-93ab-f59ed1c0f56f	2026-07-01	Warnings	Exact identifier application number: M007
ENEMEEZ	DOCUSATE SODIUM	Quest Products, LLC	0b06445d-0839-497e-bdff-e0fe224a7738	2026-06-30	Warnings	Exact identifier application number: M007
ENEMEEZ Plus	DOCUSATE SODIUM AND BENZOCAINE	Quest Products, LLC	1670ca59-7275-4ac6-bef4-674a7b24c7b3	2026-06-30	Warnings	Exact identifier application number: M007
Mineral oil	MINERAL OIL	CVS Pharmacy, Inc.	1183bcbc-51ec-e53a-e063-6394a90af0f2	2026-06-26	Warnings, Adverse reactions	Exact identifier application number: M007
Glycerin	GLYCERIN	Beijing Jingfeng Pharmaceutical (Shandong) Co., Ltd	552d9018-cc7d-7e1a-e063-6294a90a3322	2026-06-26	Warnings	Exact identifier application number: M007
Glycerin	GLYCERIN	Beijing Jingfeng Pharmaceutical (Shandong) Co., Ltd	552e16b9-f46a-7838-e063-6394a90ab8aa	2026-06-26	Warnings	Exact identifier application number: M007
Walgreens Gentle Laxative	BISACODYL SUPPOSITORY	Walgreens	20c43036-830b-0e1d-e063-6394a90adf5f	2026-06-25	Warnings	Exact identifier application number: M007
Docusate Sodium	DOCUSATE SODIUM	American Health Packaging	be7cab51-ce7e-465d-95db-083e69288cfd	2026-06-25	Warnings	Exact identifier application number: M007
Epsom Salt	MAGNESIUM SULFATE	Vi-Jon, LLC	ba490c22-19f0-4887-9509-bd3d32e0f5b1	2026-06-24	Warnings, Adverse reactions	Exact identifier application number: M007
MILK OF MAGNESIA	MAGNESIUM HYDROXIDE	KROGER COMPANY	a1b0c638-6c34-1b72-e053-2995a90acc85	2026-06-24	Warnings	Exact identifier application number: M007
Womens Laxative	WOMENS LAXTIVE	Allegiant Health	549a11d1-a096-4c22-96b4-2d4f54f46022	2026-06-24	Warnings	Exact identifier application number: M007
Magnesium Citrate	MAGNESIUM CITRATE	Meijer Distribution Inc	f4259fda-19d4-087e-e053-2995a90a7081	2026-06-22	Warnings	Exact identifier application number: M007
STOOL SOFTENER	DOCUSATE SODIUM	Geri-Care Pharmaceuticals, Corp	3ec42148-6786-22f2-e054-00144ff8d46c	2026-06-18	Warnings	Exact identifier application number: M007
Glycerin	GLYCERIN SUPPOSITORY	Everpharm LLC	546347e5-841e-15ca-e063-6294a90a0c8b	2026-06-16	Warnings	Exact identifier application number: M007
Glycerin	GLYCERIN SUPPOSITORY	Everpharm LLC	5463f869-2b92-4551-e063-6394a90ad6f9	2026-06-16	Warnings	Exact identifier application number: M007
MINICA-S	GLYCERIN	Sato Pharmaceutical Co., Ltd.	687902eb-e702-4e87-a0ce-9add05e3cbc1	2026-06-16	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