Colace

Product NDC: 67618-111
11-digit product format: 676180111
Labeler code: 67618
Product ID: 67618-111_ec10da1a-de65-47d1-ae30-07ad97469e73
Type: HUMAN OTC DRUG
Nonproprietary name: Docusate sodium
Dosage form: CAPSULE, LIQUID FILLED
Route: ORAL
Labeler: Atlantis Consumer Healthcare, Inc.
Application: M007
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 1900-01-07
Substance: DOCUSATE SODIUM
Active strength: 50 mg/1
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

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: Colace
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DOCUSATE SODIUM	50 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 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1247759	Internal RxNorm lookup
1247761	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
a1591da0-a1a9-9583-3cf5-788b8fee3814	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
67618-111-10	Colace	100 in 1 BOTTLE	CAPSULE, LIQUID FILLED	100	10
67618-111-10	Colace	1 in 1 CARTON	CAPSULE, LIQUID FILLED	1	10
67618-111-28	Colace	1 in 1 CARTON	CAPSULE, LIQUID FILLED	1	10
67618-111-28	Colace	28 in 1 BOTTLE	CAPSULE, LIQUID FILLED	28	10
67618-111-42	Colace	42 in 1 BOTTLE	CAPSULE, LIQUID FILLED	42	10
67618-111-42	Colace	1 in 1 CARTON	CAPSULE, LIQUID FILLED	1	10
67618-111-60	Colace	60 in 1 BOTTLE	CAPSULE, LIQUID FILLED	60	10
67618-111-60	Colace	1 in 1 CARTON	CAPSULE, LIQUID FILLED	1	10

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
67618-111-28	EA - Each	67618-111	83568077-dfe8-4169-b53c-57668d071625	1	2017-06-15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
67618-111	COLACE (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [ATLANTIS CONSUMER HEALTHCARE, INC.]	8	Current NDC, Legacy NDC, 8 package rows	20240113_a1591da0-a1a9-9583-3cf5-788b8fee3814.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 11 of 42 · 833 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Mineral Oil	MINERAL OIL	United Natural Foods, Inc. dba UNFI	cb7bc571-295f-47c2-ae93-18cba194752c	2026-02-17	Warnings, Adverse reactions	Exact identifier application number: M007
Mineral Oil	MINERAL OIL	Strategic Sourcing Services LLC	e4965086-dcc0-4b34-bb30-81facf7139f3	2026-02-17	Warnings, Adverse reactions	Exact identifier application number: M007
Magnesium Citrate	MAGNESIUM CITRATE	Valu Merchandisers Company	cd3e5836-b2f0-41f3-8623-3105c4642491	2026-02-16	Warnings, Adverse reactions	Exact identifier application number: M007
citroma	MAGESIUM CITRATE	Valu Merchandisers Company	a693f6b0-0679-4609-9ca0-dddfa4158c02	2026-02-16	Warnings, Adverse reactions	Exact identifier application number: M007
citroma	MAGNESIUM CITRATE	Valu Merchandisers Company	fb358bc3-e479-42e7-8aea-a6a3676f2430	2026-02-16	Warnings, Adverse reactions	Exact identifier application number: M007
Epsom Salt	MAGNESIUM SULFATE	Valu Merchandisers Company	ff539c1c-9ed3-49be-9b30-1858f12e1e90	2026-02-16	Warnings, Adverse reactions	Exact identifier application number: M007
Castor Oil	CASTOR OIL	United Natural Foods, Inc. dba UNFI	bd19bea3-5ac9-4f8d-b1a0-478fd9c8a01f	2026-02-16	Warnings, Adverse reactions	Exact identifier application number: M007
Walgreens SmoothLAX Soft Chews	MAGNESIUM HYDROXIDE	Walgreens	424e27ce-0b11-9cd2-e063-6294a90a3c21	2026-02-16	Warnings	Exact identifier application number: M007
citroma	MAGNESIUM CITRATE	United Natural Foods, Inc. dba UNFI	da013c15-3531-4dc5-b122-bfc99bc494ae	2026-02-16	Warnings, Adverse reactions	Exact identifier application number: M007
citroma	MAGNESIUM CITRATE	United Natural Foods, Inc. dba UNFI	db1bc651-1a35-4f92-a917-c6a19f421594	2026-02-16	Warnings, Adverse reactions	Exact identifier application number: M007
Stool Softener Laxative	DOCUSATE SODIUM	The Kroger Co.	e1a68bd9-d31a-46a6-8c08-7ad8197b6e0b	2026-02-13	Warnings	Exact identifier application number: M007
Epsom Salt	MAGNESIUM SULFATE	Topco Associates LLC	b2ec06b3-647d-49ab-a392-6db63d96d1e3	2026-02-13	Warnings, Adverse reactions	Exact identifier application number: M007
Castor Oil	CASTOR OIL	Topco Associates LLC	5643f2e0-93e2-4c2e-90a0-fd152150d18a	2026-02-13	Warnings, Adverse reactions	Exact identifier application number: M007
citroma	MAGESIUM CITRATE	Topco Associates LLC	d3cc7cb6-098e-413c-b1ad-7ebf5fa35269	2026-02-13	Warnings, Adverse reactions	Exact identifier application number: M007
citroma	MAGNESIUM CITRATE	Topco Associates LLC	bc89c4bc-5207-479d-9a3b-e570b412a7ba	2026-02-13	Warnings, Adverse reactions	Exact identifier application number: M007
Epsom Salt	MAGNESIUM SULFATE	Topco Associates LLC	72f69aa0-381a-4e5c-975d-3a73fdc1b377	2026-02-13	Warnings, Adverse reactions	Exact identifier application number: M007
Mineral Oil	MINERAL OIL	Topco Associates LLC	e9b1fd61-c229-4529-82c2-d6ac5b076082	2026-02-13	Warnings	Exact identifier application number: M007
Magnesium Citrate	MAGNESIUM CITRATE	Pinnacle RX LLC	4abbb0e4-e005-bc4e-e063-6394a90a126a	2026-02-13	Warnings, Adverse reactions	Exact identifier application number: M007
365 Whole Foods Market Epsom Salt	MAGNESIUM SULFATE	Whole Foods Market, Inc.	4147cdd0-57f6-3857-e063-6394a90afecb	2026-02-12	Warnings, Adverse reactions	Exact identifier application number: M007
Epsom Salt	MAGNESIUM SULFATE	Your Military Exchanges	27cff497-123c-424a-9c43-57740c00168b	2026-02-12	Warnings, Adverse reactions	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
1247761	Colace 50 MG Oral Capsule	PSN	a1591da0-a1a9-9583-3cf5-788b8fee3814	10
1247759	docusate sodium 50 MG Oral Capsule	PSN	a1591da0-a1a9-9583-3cf5-788b8fee3814	10
1247761	docusate sodium 50 MG Oral Capsule [Colace]	SBD	a1591da0-a1a9-9583-3cf5-788b8fee3814	10
1247759	docusate sodium 50 MG Oral Capsule	SCD	a1591da0-a1a9-9583-3cf5-788b8fee3814	10
1247761	Colace 50 MG Oral Capsule	SY	a1591da0-a1a9-9583-3cf5-788b8fee3814	10
1247759	DOSS Sodium 50 MG Oral Capsule	SY	a1591da0-a1a9-9583-3cf5-788b8fee3814	10
1247761	DOSS Sodium 50 MG Oral Capsule [Colace]	SY	a1591da0-a1a9-9583-3cf5-788b8fee3814	10

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
67618-111-10	67618011110	1 BOTTLE in 1 CARTON (67618-111-10) / 100 CAPSULE, LIQUID FILLED in 1 BOTTLE	1 bottle	2025-12-01		No	No	Current
67618-111-28	67618011128	1 BOTTLE in 1 CARTON (67618-111-28) / 28 CAPSULE, LIQUID FILLED in 1 BOTTLE	1 bottle	1900-01-07	0000-00-00	No	No	Current
67618-111-42	67618011142	1 BOTTLE in 1 CARTON (67618-111-42) / 42 CAPSULE, LIQUID FILLED in 1 BOTTLE	1 bottle	2024-02-01		No	No	Current
67618-111-60	67618011160	1 BOTTLE in 1 CARTON (67618-111-60) / 60 CAPSULE, LIQUID FILLED in 1 BOTTLE	1 bottle	2024-04-01		No	No	Current