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 34 of 42 · 833 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Senna-S	SENNOSIDES 8.6MG AND DOCUSATE SODIUM 50MG	Proficient Rx LP	8678a3ee-0e2c-4c95-ad2e-83aa601f3238	2024-10-01	Warnings	Exact identifier application number: M007
Pedia-Lax	DOCUSATE SODIUM	C.B. Fleet Company, Inc.	0e908bea-ebab-44e7-919c-90002e6f5d42	2024-10-01	Warnings	Exact identifier application number: M007
Natural Vegetable Laxative and Stool Softener	DOCUSATE SODIUM AND SENNOSIDES	BETTER LIVING BRANDS LLC.	f2c562e1-4080-44cb-e053-2a95a90a4222	2024-09-25	Warnings	Exact identifier application number: M007
SENNA-S LAXATIVE WITH STOOL SOFTENER	SENNOSIDES	Basic Drugs, Inc.	d32b9956-fc04-8d64-e053-2a95a90a17b3	2024-09-14	Warnings	Exact identifier application number: M007
DOCUSATE SODIUM, EXTRA STRENGTH 250 MG	DOCUSATE SODIUM	Advanced Rx LLC	e8be12c5-c591-eadd-e053-2a95a90a431b	2024-09-13	Warnings	Exact identifier application number: M007
Senna	SENNOSIDES	Proficient Rx LP	5f7f0df4-dabe-4c8f-a2b5-766f20af2f46	2024-09-01	Warnings	Exact identifier application number: M007
Fiber caplets 147	CALCIUM POLYCARBOPHIL	Chain Drug Marketing Association Inc.	17e2a50d-1867-49fe-e063-6394a90a56df	2024-08-27	Warnings	Exact identifier application number: M007
MAXIMUM STRENGTH LAXATIVE PILLS	SENNOSIDES	TARGET CORPORATION	7cae52ae-931c-3e7c-e053-2991aa0a8396	2024-08-22	Warnings	Exact identifier application number: M007
STOOL SOFTENER AND STIMULANT LAXATIVE	DOCUSATE SODIUM AND SENNOSIDES	TARGET CORPORATION	7cac99da-8d89-0aee-e053-2991aa0a0fd9	2024-08-22	Warnings	Exact identifier application number: M007
SENNA LAXATIVE	SENNOSIDES 8.6 MG	TARGET CORPORATION	7cab058f-3647-7124-e053-2a91aa0a41bd	2024-08-22	Warnings	Exact identifier application number: M007
Docusate Sodium	DOCUSATE SODIUM	Padagis Israel Pharmaceuticals Ltd	bce3b245-ec47-4e62-9cad-bb12d0812c18	2024-08-15	Warnings	Exact identifier application number: M007
Docusate Sodium	DOCUSATE SODIUM	NuCare Pharmaceuticals,Inc.	56f7966a-c95e-3ce3-e054-00144ff88e88	2024-08-14	Warnings	Exact identifier application number: M007
Stool Softener Laxative	DOCUSATE SODIUM	Proficient Rx LP	ccfa095c-77f0-41ff-84f8-e02d983c7c74	2024-08-01	Warnings	Exact identifier application number: M007
Magnesium Citrate	HARRIS TEETER MAGNESIUM CITRATE ORAL SOLUTION - LEMON	Harris Teeter, LLC	1e8e01fc-2c89-9722-e063-6394a90a6acf	2024-07-31	Warnings	Exact identifier application number: M007
Senna laxative	SENNOSIDES	Best Choice (Valu Merchandisers Company)	d5f90aa1-78e5-491f-b09d-399d54f3def1	2024-07-31	Warnings	Exact identifier application number: M007
Stool Softener Laxative Plus Stimulant	DOCUSATE SODIUM AND SENNOSIDES	Walgreens	db528659-768a-46e0-a340-9fbcdb25ea5e	2024-07-25	Warnings	Exact identifier application number: M007
Senna laxative	SENNOSIDES	Walgreens	bfa089a6-4767-45e0-b663-ee7e8949d9a4	2024-07-25	Warnings	Exact identifier application number: M007
Dr. Fibra	PSYLLIUM HUSK	Pharmadel LLC	1a6151c9-e1c4-f0c1-e063-6394a90aad24	2024-07-22	Warnings	Exact identifier application number: M007
BISACODYL	BISCODYL	TARGET CORPORATION	8ed281d5-b17e-e3bb-e053-2995a90a2590	2024-07-15	Warnings	Exact identifier application number: M007
Stool Softener	DOCUSATE CALCIUM	Walgreens	b6f0770e-671d-4965-9275-b1c224d7f06a	2024-07-10	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