Dulcolax

Product NDC: 0597-0016
11-digit product format: 005970016
Labeler code: 0597
Product ID: 0597-0016_ac8d5286-b70b-d2b0-3526-79e42a106581
Type: HUMAN OTC DRUG
Nonproprietary name: Docusate sodium
Dosage form: CAPSULE, LIQUID FILLED
Route: ORAL
Labeler: Boehringer Ingelheim Pharmaceuticals, Inc.
Application: part334
Marketing category: OTC MONOGRAPH NOT FINAL
Marketing start: 2002-10-01
Marketing end: 0000-00-00
Substance: DOCUSATE SODIUM
Active strength: 100 mg/1
NDC exclude flag: No
Listing certified through: 2019-12-31
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 · 7 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	0597-0016		D	Discontinued by firm	2026-08-11
excluded package	package	0597-0016	0597-0016-01	D	Discontinued by firm	2026-08-11
excluded package	package	0597-0016	0597-0016-18	D	Discontinued by firm	2026-08-11
excluded package	package	0597-0016	0597-0016-26	D	Discontinued by firm	2026-08-11
excluded package	package	0597-0016	0597-0016-50	D	Discontinued by firm	2026-08-11
excluded package	package	0597-0016	0597-0016-55	D	Discontinued by firm	2026-08-11
excluded package	package	0597-0016	0597-0016-56	D	Discontinued by firm	2026-08-11

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 2 · 98 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	0597-0016-56	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0597-0016-26	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0597-0016-01	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0597-0016-55	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0597-0016-18	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0597-0016-50	`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	0597-0016-56	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0597-0016-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0597-0016-01	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0597-0016-55	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0597-0016-18	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0597-0016-50	`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	0597-0016-56	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0597-0016-26	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0597-0016-01	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0597-0016-55	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0597-0016-18	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0597-0016-50	`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	0597-0016-56	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0597-0016-26	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0597-0016-01	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0597-0016-55	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0597-0016-18	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0597-0016-50	`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	0597-0016-56	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0597-0016-26	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0597-0016-01	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0597-0016-55	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0597-0016-18	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0597-0016-50	`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	0597-0016-56	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0597-0016-26	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0597-0016-01	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0597-0016-55	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0597-0016-18	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0597-0016-50	`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	0597-0016-56	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0597-0016-26	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0597-0016-01	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0597-0016-55	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0597-0016-18	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0597-0016-50	`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	0597-0016-56	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0597-0016-26	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0597-0016-01	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0597-0016-55	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0597-0016-18	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0597-0016-50	`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	0597-0016-56	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0597-0016-26	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0597-0016-01	`0efc9e666f02…`	`f202fb6c5f17…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
0597-0016-01	2021-11-08	Dulcolax® Stool Softener (docusate sodium USP 100mg)
0597-0016-18	2021-11-08	Dulcolax® Stool Softener (docusate sodium USP 100mg)
0597-0016-26	2021-11-08	Dulcolax® Stool Softener (docusate sodium USP 100mg)
0597-0016-50	2021-11-08	Dulcolax® Stool Softener (docusate sodium USP 100mg)
0597-0016-55	2021-11-08	Dulcolax® Stool Softener (docusate sodium USP 100mg)
0597-0016-56	2021-11-08	Dulcolax® Stool Softener (docusate sodium USP 100mg)
0597-0016-01	2020-01-31	Dulcolax® Stool Softener (docusate sodium USP 100mg)
0597-0016-18	2020-01-31	Dulcolax® Stool Softener (docusate sodium USP 100mg)
0597-0016-26	2020-01-31	Dulcolax® Stool Softener (docusate sodium USP 100mg)
0597-0016-50	2020-01-31	Dulcolax® Stool Softener (docusate sodium USP 100mg)
0597-0016-55	2020-01-31	Dulcolax® Stool Softener (docusate sodium USP 100mg)
0597-0016-56	2020-01-31	Dulcolax® Stool Softener (docusate sodium USP 100mg)

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
docusate sodium	ACTIVE INGREDIENT	F05Q2T2JA0	DULCOLAX (DOCUSATE SODIUM) GEL [BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.]	2
docusate	ACTIVE MOIETY	M7P27195AG	DULCOLAX (DOCUSATE SODIUM) GEL [BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.]	2
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	DULCOLAX (DOCUSATE SODIUM) GEL [BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.]	2
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	DULCOLAX (DOCUSATE SODIUM) GEL [BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.]	2
GELATIN	INACTIVE INGREDIENT	2G86QN327L	DULCOLAX (DOCUSATE SODIUM) GEL [BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.]	2
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	DULCOLAX (DOCUSATE SODIUM) GEL [BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.]	2
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	DULCOLAX (DOCUSATE SODIUM) GEL [BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.]	2
MANNITOL	INACTIVE INGREDIENT	3OWL53L36A	DULCOLAX (DOCUSATE SODIUM) GEL [BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.]	2
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	DULCOLAX (DOCUSATE SODIUM) GEL [BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.]	2
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	DULCOLAX (DOCUSATE SODIUM) GEL [BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.]	2
SORBITAN	INACTIVE INGREDIENT	6O92ICV9RU	DULCOLAX (DOCUSATE SODIUM) GEL [BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.]	2
SORBITOL	INACTIVE INGREDIENT	506T60A25R	DULCOLAX (DOCUSATE SODIUM) GEL [BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	DULCOLAX (DOCUSATE SODIUM) GEL [BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.]	2
WATER	INACTIVE INGREDIENT	059QF0KO0R	DULCOLAX (DOCUSATE SODIUM) GEL [BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.]	2

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
Dulcolax® Stool Softener (docusate sodium USP 100mg)	Boehringer Ingelheim Pharmaceuticals, Inc.	2017-12-19	HUMAN OTC DRUG LABEL	4

Dulcolax

NDC auxiliary status#

Observed NDC auxiliary status history#

FDA-Initiated Inactive NDC Indexing#

DailyMed Socrata Ingredients#

Related Records#

Related UNII Ingredients#

Related DailyMed Labels#