Dulcolax Stool Softener

Product NDC: 41167-0221
11-digit product format: 411670221
Labeler code: 41167
Product ID: 41167-0221_30425636-e884-4991-b31b-1d56948a6953
Type: HUMAN OTC DRUG
Nonproprietary name: Docusate sodium
Dosage form: CAPSULE, LIQUID FILLED
Route: ORAL
Labeler: Chattem, Inc.
Application: M007
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2020-08-01
Substance: DOCUSATE SODIUM
Active strength: 100 mg/1
NDC exclude flag: No
Listing certified through: 2026-12-31
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	41167-0221	41167-0221-9	D	Discontinued by firm		2026-10-21

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 · 10 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`

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: Dulcolax Stool Softener
Listing expiration: 2026-12-31

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
86cb7102-3585-4757-9c37-5bf9776bbe63	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
41167-0221-2	Dulcolax Stool Softener	1 in 1 CARTON	CAPSULE, LIQUID FILLED	1	7
41167-0221-2	Dulcolax Stool Softener	25 in 1 BOTTLE	CAPSULE, LIQUID FILLED	25	7
41167-0221-3	Dulcolax Stool Softener	1 in 1 CARTON	CAPSULE, LIQUID FILLED	1	7
41167-0221-3	Dulcolax Stool Softener	50 in 1 BOTTLE	CAPSULE, LIQUID FILLED	50	7
41167-0221-4	Dulcolax Stool Softener	1 in 1 CARTON	CAPSULE, LIQUID FILLED	1	7
41167-0221-4	Dulcolax Stool Softener	100 in 1 BOTTLE	CAPSULE, LIQUID FILLED	100	7
41167-0221-9	Dulcolax Stool Softener	30 in 1 BOTTLE	CAPSULE, LIQUID FILLED	30	7
41167-0221-9	Dulcolax Stool Softener	1 in 1 CARTON	CAPSULE, LIQUID FILLED	1	7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
41167-0221	DULCOLAX STOOL SOFTENER (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [CHATTEM, INC.]	6	Current NDC, Legacy NDC, 8 package rows	20250308_86cb7102-3585-4757-9c37-5bf9776bbe63.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 42 of 42 · 829 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Topcare Stool Softener	DOCUSATE SODIUM	TopCo Associates, LLC	6f4fddda-4129-4087-b0e4-ababc5558484	2021-02-19	Warnings	Exact identifier application number: M007
Stool Softener	DOCUSATE SODIUM	Allegiant Health	30c9ff75-cee4-4632-86fd-acfdf5ee85af	2020-10-27	Warnings	Exact identifier application number: M007
Stool Softener	MARC GLASSMAN	Marc Glassman, Inc.	909cd222-d836-416f-aa7d-deb4a0c5a560	2020-09-08	Warnings	Exact identifier application number: M007
Senna Lax	SENNOSIDES 8.6MG	Allegiant Health	94a9c24a-07c3-4535-b810-b7abc9fc5ad5	2019-12-11	Warnings	Exact identifier application number: M007
Laxative Enteric Coated	BISACODYL 5MG	Marc Glassman, Inc.	ec34fc1e-d122-4fa4-859e-e89e3e12edd5	2019-09-18	Warnings	Exact identifier application number: M007
Womens Laxative	BISACODYL	Marc Glassman, Inc.	aeb3c49b-cbf5-4a47-b19c-e77fbb987a49	2019-09-17	Warnings	Exact identifier application number: M007
Bisacodyl 5mg	BISACODYL 5MG	Allegiant Health	46a377f5-822b-496f-a73b-66d8f902680a	2019-03-26	Warnings	Exact identifier application number: M007
Laxative Enteric Coated	BISACODYL 5MG	Allegiant Health	51f1c6c0-770c-4426-820b-bc1f42e143fd	2019-02-07	Warnings	Exact identifier application number: M007
Senna-Lax	SENNOSIDES	Marc Glassman, Inc.	7dd97c54-2ba1-4629-87b9-1ba0913fe531	2016-12-27	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	86cb7102-3585-4757-9c37-5bf9776bbe63	7
1115005	docusate sodium 100 MG Oral Capsule	SCD	86cb7102-3585-4757-9c37-5bf9776bbe63	7
1115005	DOSS Sodium 100 MG Oral Capsule	SY	86cb7102-3585-4757-9c37-5bf9776bbe63	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
41167-0221-2	41167022102	1 BOTTLE in 1 CARTON (41167-0221-2) / 25 CAPSULE, LIQUID FILLED in 1 BOTTLE	1 bottle	2020-08-01	0000-00-00	No	No	Current
41167-0221-3	41167022103	1 BOTTLE in 1 CARTON (41167-0221-3) / 50 CAPSULE, LIQUID FILLED in 1 BOTTLE	1 bottle	2020-08-01	0000-00-00	No	No	Current
41167-0221-4	41167022104	1 BOTTLE in 1 CARTON (41167-0221-4) / 100 CAPSULE, LIQUID FILLED in 1 BOTTLE	1 bottle	2020-08-01	0000-00-00	No	No	Current
41167-0221-9	41167022109	1 BOTTLE in 1 CARTON (41167-0221-9) > 30 CAPSULE, LIQUID FILLED in 1 BOTTLE	1 bottle	2020-08-01	0000-00-00	No	No	Current