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 16 of 42 · 833 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Senna-S	DOCUSATE SODIUM 50MG AND SENNOSIDES 8.6MG	Walgreens	36cc3a5b-1891-d39e-e063-6294a90a93b4	2025-12-31	Warnings	Exact identifier application number: M007
Senna Liquid	SENNOSIDES	RUGBY LABORATORIES	8123b092-2ae9-459b-ae06-6ceb837adcf8	2025-12-30	Warnings	Exact identifier application number: M007
Docusate Sodium Liquid	DOCUSATE SODIUM	RUGBY LABORATORIES	e21d19d8-6c2d-4474-a663-dfe7e91ac320	2025-12-30	Warnings	Exact identifier application number: M007
MILK OF MAGNESIA	MAGNESIUM HYDROXIDE	RUGBY LABORATORIES	b1bafa6e-0f54-1c35-e053-2995a90a42e4	2025-12-30	Warnings	Exact identifier application number: M007
OneLAX SENNA	SENNA	ATLANTIC BIOLOGICALS CORP.	d2a5a13a-e7e4-488a-b60b-4dd467efa971	2025-12-29	Warnings	Exact identifier application number: M007
Senna Syrup	SENNOSIDES	Llorens Pharmaceutical International Division, Inc.	5be0163c-b7f7-46db-b738-78c2946a6cf6	2025-12-29	Warnings	Exact identifier application number: M007
Senokot	STANDARDIZED SENNA CONCENTRATE	Atlantis Consumer Healthcare, Inc.	c18dd7fa-993b-440b-8cdd-f1551abb99ca	2025-12-29	Warnings	Exact identifier application number: M007
LAXATIVE	BISACODYL	GRAXCELL PHARMACEUTICAL, LLC	5a65d4ab-447f-42bb-b38d-070db523b806	2025-12-25	Warnings	Exact identifier application number: M007
Senna-S	SENNOSIDES 8.6MG AND DOCUSATE SODIUM 50MG	Pharbest Pharmaceuticals, Inc.	2b5152b2-d354-409f-a19f-b470f4181b3f	2025-12-24	Warnings	Exact identifier application number: M007
Senna Tabs	SENNA	Pharbest Pharmaceuticals, Inc.	b9f8ea59-932f-4827-a87c-b4aff909c43f	2025-12-24	Warnings	Exact identifier application number: M007
Senna Plus	DOCUSATE SODIUM 50 MG AND SENNOSIDES 8.6 MG	CARDINAL HEALTH, 110 DBA LEADER	4d4101ca-7d78-4712-9b3d-f395f2646c6b	2025-12-23	Warnings	Exact identifier application number: M007
Equate Gentle Laxative Soft chew	MAGNESIUM HYDROXIDE	Walmart	0997c1b7-16db-7db7-e063-6294a90a5928	2025-12-23	Warnings	Exact identifier application number: M007
Equate Kids Gentle Laxative SC	MAGNESIUM HYDROXIDE	Walmart	1662a542-aef0-9087-e063-6294a90aa6d9	2025-12-23	Warnings	Exact identifier application number: M007
AMAZON FIBER CAPLETS	CALCIUM POLYCARBOPHIL	AMAZON.COM SERVICES LLC	178f4150-c75c-45e1-a5f3-3af67b5c8109	2025-12-22	Warnings	Exact identifier application number: M007
AMAZON FIBER THERAPY	METHYLCELLULOSE	AMAZON.COM SERVICES LLC	3eee7b21-5401-4ef1-b1c6-1013439639d2	2025-12-22	Warnings	Exact identifier application number: M007
Sennosides	SENNOSIDES	Granules USA Inc	a619b8f4-1b5d-181b-e053-2995a90ab729	2025-12-22	Warnings	Exact identifier application number: M007
CAREALL Sennosides	SENNOSIDES	New World Imports, Inc	61bbbb6a-9997-4df1-94be-a80686d1f1b9	2025-12-22	Warnings	Exact identifier application number: M007
Walgreens Blueberry Raspberry Gentle Laxative	MAGNESIUM HYDROXIDE	Walgreen	d35f1518-bc63-83eb-e053-2995a90ae4bb	2025-12-21	Warnings	Exact identifier application number: M007
Sennosides	SENNOSIDES	Walgreens Co	85a2f7ed-315e-2403-e053-2991aa0abdce	2025-12-19	Warnings	Exact identifier application number: M007
Sennosides	SENNOSIDES	H E B	a5652d5b-43fd-5bfa-e053-2995a90aad6c	2025-12-19	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
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