Stool Softener

Product NDC: 49348-483
11-digit product format: 493480483
Labeler code: 49348
Product ID: 49348-483_94d632eb-69cd-4aa0-b429-38c28785c0bb
Type: HUMAN OTC DRUG
Nonproprietary name: DOCUSATE SODIUM
Dosage form: CAPSULE, LIQUID FILLED
Route: ORAL
Labeler: Strategic Sourcing Services LLC
Application: part334
Marketing category: OTC MONOGRAPH NOT FINAL
Marketing start: 2013-08-15
Marketing end: 2021-12-30
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	49348-483		D	Discontinued by firm	2026-10-05
excluded package	package	49348-483	49348-483-10	D	Discontinued by firm	2026-10-05
excluded package	package	49348-483	49348-483-19	D	Discontinued by firm	2026-10-05
excluded package	package	49348-483	49348-483-90	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	49348-483-10	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	49348-483-19	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	49348-483-90	`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	49348-483-10	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	49348-483-19	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	49348-483-90	`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	49348-483-10	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	49348-483-19	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	49348-483-90	`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	49348-483-10	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	49348-483-19	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	49348-483-90	`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	49348-483-10	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	49348-483-19	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	49348-483-90	`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	49348-483-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	49348-483-19	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	49348-483-90	`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	49348-483-10	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	49348-483-19	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	49348-483-90	`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	49348-483-10	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	49348-483-19	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	49348-483-90	`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	49348-483-10	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	49348-483-19	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	49348-483-90	`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	49348-483-10	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	49348-483-19	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	49348-483-90	`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	49348-483-10	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	49348-483-19	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	49348-483-90	`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	49348-483-10	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	49348-483-19	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	49348-483-90	`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
49348-483-10	EA - Each	49348-483	e5f55ecd-2bd7-44a1-a9db-2fb661aef4ef	1	2014-04-03
49348-483-19	EA - Each	49348-483	be5b3578-9769-4be4-9abb-7fec4a75c918	1	2014-06-03
49348-483-90	EA - Each	49348-483	6867b5e9-9b49-4acb-aa39-3ea9c7e4449f	1	2015-07-20

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 [MCKESSON (SUNMARK)]	1
DOCUSATE	ACTIVE MOIETY	M7P27195AG	STOOL SOFTENER (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [MCKESSON (SUNMARK)]	1
D&C RED NO. 33	INACTIVE INGREDIENT	9DBA0SBB0L	STOOL SOFTENER (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [MCKESSON (SUNMARK)]	1
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	STOOL SOFTENER (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [MCKESSON (SUNMARK)]	1
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	STOOL SOFTENER (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [MCKESSON (SUNMARK)]	1
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	STOOL SOFTENER (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [MCKESSON (SUNMARK)]	1
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	STOOL SOFTENER (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [MCKESSON (SUNMARK)]	1
GELATIN	INACTIVE INGREDIENT	2G86QN327L	STOOL SOFTENER (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [MCKESSON (SUNMARK)]	1
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	STOOL SOFTENER (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [MCKESSON (SUNMARK)]	1
LECITHIN, SOYBEAN	INACTIVE INGREDIENT	1DI56QDM62	STOOL SOFTENER (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [MCKESSON (SUNMARK)]	1
MEDIUM-CHAIN TRIGLYCERIDES	INACTIVE INGREDIENT	C9H2L21V7U	STOOL SOFTENER (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [MCKESSON (SUNMARK)]	1
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	STOOL SOFTENER (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [MCKESSON (SUNMARK)]	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	STOOL SOFTENER (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [MCKESSON (SUNMARK)]	1
SORBITAN	INACTIVE INGREDIENT	6O92ICV9RU	STOOL SOFTENER (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [MCKESSON (SUNMARK)]	1
SORBITOL	INACTIVE INGREDIENT	506T60A25R	STOOL SOFTENER (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [MCKESSON (SUNMARK)]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	STOOL SOFTENER (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [MCKESSON (SUNMARK)]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	STOOL SOFTENER (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [MCKESSON (SUNMARK)]	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
49348-483-10	49348048310	100 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (49348-483-10)	2013-08-15	2021-12-30	No	No	Current
49348-483-19	49348048319	250 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (49348-483-19)	2013-08-15	2021-12-30	No	No	Current
49348-483-90	49348048390	400 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (49348-483-90)	2013-08-15	2021-12-30	No	No	Current