Stool Softener

Product NDC: 49781-037
11-digit product format: 497810037
Labeler code: 49781
Product ID: 49781-037_80e49eba-d916-4abf-b0c4-f15a53fbf687
Type: HUMAN OTC DRUG
Nonproprietary name: DOCUSATE SODIUM
Dosage form: CAPSULE, LIQUID FILLED
Route: ORAL
Labeler: Cardinal Health (Leader) 49781
Application: part334
Marketing category: OTC MONOGRAPH NOT FINAL
Marketing start: 2013-09-30
Marketing end: 2019-12-31
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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	49781-037		D	Discontinued by firm	2026-10-05
excluded package	package	49781-037	49781-037-51	D	Discontinued by firm	2026-10-05
excluded package	package	49781-037	49781-037-56	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 · 36 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	49781-037-56	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	49781-037-51	`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	49781-037-56	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	49781-037-51	`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	49781-037-56	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	49781-037-51	`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	49781-037-56	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	49781-037-51	`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	49781-037-56	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	49781-037-51	`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	49781-037-56	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	49781-037-51	`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	49781-037-56	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	49781-037-51	`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	49781-037-56	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	49781-037-51	`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	49781-037-56	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	49781-037-51	`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	49781-037-56	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	49781-037-51	`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	49781-037-56	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	49781-037-51	`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	49781-037-56	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	49781-037-51	`557ba5c1ecfa…`	`9c80585c8c6e…`

Reported adverse events (FAERS/openFDA)#

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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
49781-037-51	EA - Each	49781-037	837a6eef-c598-4639-b98e-5cc2872f46a0	1	2018-09-05

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 [CARDINAL HEALTH (LEADER) 49781]	4
DOCUSATE	ACTIVE MOIETY	M7P27195AG	STOOL SOFTENER (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [CARDINAL HEALTH (LEADER) 49781]	4
D&C RED NO. 33	INACTIVE INGREDIENT	9DBA0SBB0L	STOOL SOFTENER (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [CARDINAL HEALTH (LEADER) 49781]	4
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	STOOL SOFTENER (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [CARDINAL HEALTH (LEADER) 49781]	4
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	STOOL SOFTENER (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [CARDINAL HEALTH (LEADER) 49781]	4
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	STOOL SOFTENER (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [CARDINAL HEALTH (LEADER) 49781]	4
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	STOOL SOFTENER (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [CARDINAL HEALTH (LEADER) 49781]	4
GELATIN	INACTIVE INGREDIENT	2G86QN327L	STOOL SOFTENER (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [CARDINAL HEALTH (LEADER) 49781]	4
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	STOOL SOFTENER (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [CARDINAL HEALTH (LEADER) 49781]	4
LECITHIN, SOYBEAN	INACTIVE INGREDIENT	1DI56QDM62	STOOL SOFTENER (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [CARDINAL HEALTH (LEADER) 49781]	4
MEDIUM-CHAIN TRIGLYCERIDES	INACTIVE INGREDIENT	C9H2L21V7U	STOOL SOFTENER (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [CARDINAL HEALTH (LEADER) 49781]	4
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	STOOL SOFTENER (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [CARDINAL HEALTH (LEADER) 49781]	4
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	STOOL SOFTENER (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [CARDINAL HEALTH (LEADER) 49781]	4
SORBITAN	INACTIVE INGREDIENT	6O92ICV9RU	STOOL SOFTENER (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [CARDINAL HEALTH (LEADER) 49781]	4
SORBITOL	INACTIVE INGREDIENT	506T60A25R	STOOL SOFTENER (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [CARDINAL HEALTH (LEADER) 49781]	4
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	STOOL SOFTENER (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [CARDINAL HEALTH (LEADER) 49781]	4
WATER	INACTIVE INGREDIENT	059QF0KO0R	STOOL SOFTENER (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [CARDINAL HEALTH (LEADER) 49781]	4

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

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Drug Facts	Cardinal Health (Leader) 49781 \| P & L Development, LLC	2018-12-19	HUMAN OTC DRUG LABEL	5

Stool Softener

NDC auxiliary status#

Observed NDC auxiliary status history#

Reported adverse events (FAERS/openFDA)#

DailyMed Billing Units#

DailyMed Socrata Ingredients#

Related Records#

Related UNII Ingredients#

Related DailyMed Labels#