Stool Softener

Product NDC: 61715-081
11-digit product format: 617150081
Labeler code: 61715
Product ID: 61715-081_c4848458-4f58-403a-b916-453d7de5dafa
Type: HUMAN OTC DRUG
Nonproprietary name: DOCUSATE SODIUM
Dosage form: CAPSULE, LIQUID FILLED
Route: ORAL
Labeler: Preferred Plus (Kinray)
Application: part334
Marketing category: OTC MONOGRAPH NOT FINAL
Marketing start: 2013-09-30
Marketing end: 2022-12-30
Substance: DOCUSATE SODIUM
Active strength: 100 mg/1
NDC exclude flag: No
Listing certified through: 0000-00-00
Current FDA listing: Historical FDA.report record

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 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	61715-081		D	Discontinued by firm	2026-10-05
excluded package	package	61715-081	61715-081-51	D	Discontinued by firm	2026-10-05
excluded package	package	61715-081	61715-081-57	D	Discontinued by firm	2026-10-05
excluded package	package	61715-081	61715-081-99	D	Discontinued by firm	2026-10-05

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 · 48 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	61715-081-57	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	61715-081-51	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	61715-081-99	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	61715-081-57	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	61715-081-51	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	61715-081-99	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	61715-081-57	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	61715-081-51	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	61715-081-99	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	61715-081-57	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	61715-081-51	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	61715-081-99	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	61715-081-57	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	61715-081-51	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	61715-081-99	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	61715-081-57	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	61715-081-51	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	61715-081-99	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	61715-081-57	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	61715-081-51	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	61715-081-99	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	61715-081-57	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	61715-081-51	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	61715-081-99	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	61715-081-57	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	61715-081-51	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	61715-081-99	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	61715-081-57	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	61715-081-51	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	61715-081-99	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	61715-081-57	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	61715-081-51	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	61715-081-99	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	61715-081-57	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	61715-081-51	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	61715-081-99	`557ba5c1ecfa…`	`9c80585c8c6e…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
DOCUSATE SODIUM	ACTIVE INGREDIENT	F05Q2T2JA0	STOOL SOFTENER (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [PREFERRED PLUS (KINRAY)]	1
DOCUSATE	ACTIVE MOIETY	M7P27195AG	STOOL SOFTENER (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [PREFERRED PLUS (KINRAY)]	1
D&C RED NO. 33	INACTIVE INGREDIENT	9DBA0SBB0L	STOOL SOFTENER (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [PREFERRED PLUS (KINRAY)]	1
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	STOOL SOFTENER (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [PREFERRED PLUS (KINRAY)]	1
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	STOOL SOFTENER (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [PREFERRED PLUS (KINRAY)]	1
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	STOOL SOFTENER (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [PREFERRED PLUS (KINRAY)]	1
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	STOOL SOFTENER (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [PREFERRED PLUS (KINRAY)]	1
GELATIN	INACTIVE INGREDIENT	2G86QN327L	STOOL SOFTENER (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [PREFERRED PLUS (KINRAY)]	1
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	STOOL SOFTENER (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [PREFERRED PLUS (KINRAY)]	1
LECITHIN, SOYBEAN	INACTIVE INGREDIENT	1DI56QDM62	STOOL SOFTENER (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [PREFERRED PLUS (KINRAY)]	1
MEDIUM-CHAIN TRIGLYCERIDES	INACTIVE INGREDIENT	C9H2L21V7U	STOOL SOFTENER (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [PREFERRED PLUS (KINRAY)]	1
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	STOOL SOFTENER (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [PREFERRED PLUS (KINRAY)]	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	STOOL SOFTENER (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [PREFERRED PLUS (KINRAY)]	1
SORBITAN	INACTIVE INGREDIENT	6O92ICV9RU	STOOL SOFTENER (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [PREFERRED PLUS (KINRAY)]	1
SORBITOL	INACTIVE INGREDIENT	506T60A25R	STOOL SOFTENER (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [PREFERRED PLUS (KINRAY)]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	STOOL SOFTENER (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [PREFERRED PLUS (KINRAY)]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	STOOL SOFTENER (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [PREFERRED PLUS (KINRAY)]	1

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
F05Q2T2JA0	DOCUSATE SODIUM	577-11-7	DOCUSATE SODIUM

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
61715-081-51	61715008151	100 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (61715-081-51)	2013-09-30	2022-12-30	No	No	Current
61715-081-57	61715008157	250 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (61715-081-57)	2013-09-30	2022-12-30	No	No	Current
61715-081-99	61715008199	1000 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (61715-081-99)	2013-09-30	2022-12-30	No	No	Current

Stool Softener

NDC auxiliary status#

Observed NDC auxiliary status history#

Reported adverse events (FAERS/openFDA)#

DailyMed Socrata Ingredients#

Related Records#

Related UNII Ingredients#

Packages#

Related DailyMed Labels#