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 36 of 42 · 833 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Stool Softener Laxative	DOCUSATE SODIUM	United Natural Foods, Inc. dba UNFI	b1d903a5-1d5f-44d4-9939-a4b86e5a620d	2024-05-23	Warnings	Exact identifier application number: M007
Senna laxative	SENNOSIDES	United Natural Foods, Inc. dba UNFI	30b9bbf3-0a64-41de-bfb4-5c8c257cc3e8	2024-05-23	Warnings	Exact identifier application number: M007
Gentle Laxative	MAGNESIUM HYDROXIDE	MEIJER, INC.	11fe5bd0-585a-ad8a-e063-6294a90a3ae8	2024-05-22	Warnings	Exact identifier application number: M007
Stool Softener	DOCUSATE SODIUM	Sam's West, Inc	b14d2495-1092-4063-869f-73a7e8c28708	2024-05-21	Warnings	Exact identifier application number: M007
Stool Softener Plus Stimulant Laxative	DOCUSATE SODIUM AND SENNOSIDES	Safeway, Inc.	6bc9ea37-31b8-4a6d-9b2d-2c80bad4f30d	2024-05-15	Warnings	Exact identifier application number: M007
Stool Softener Plus Stimulant Laxative	DOCUSATE SODIUM AND SENNOSIDES	Safeway, Inc.	c0898583-4bbb-41d5-9e84-00cca823024f	2024-05-15	Warnings	Exact identifier application number: M007
Senna S	DOCUSATE SODIUM SENNOSIDES	QUALITY CHOICE (Chain Drug Marketing Association)	9c986ca8-d540-49c1-b092-94c1bf837c07	2024-05-09	Warnings	Exact identifier application number: M007
Fleet	GLYCERIN	C.B. Fleet Company, Inc.	381f4179-0c3b-41f8-927c-c88534ebe06d	2024-05-06	Warnings	Exact identifier application number: M007
Docusate Sodium	DOCUSATE SODIUM	NuCare Pharmaceuticals,Inc.	ed20d198-e935-200e-e053-2a95a90a309b	2024-05-02	Warnings	Exact identifier application number: M007
Sennosides, Docusate Sodium	SENNOSIDES, DOCUSATE SODIUM	Major Pharmaceuticals	1768b470-2808-fa46-e063-6394a90ac8d9	2024-05-01	Warnings	Exact identifier application number: M007
Stool Softener Stimulant laxative	DOCUSATE SODIUM AND SENNOSIDES	QUALITY CHOICE (Chain Drug Marketing Association)	9467e1f7-19bb-4fb3-853b-75c4d28bb9a9	2024-05-01	Warnings	Exact identifier application number: M007
Stool Softener Laxative	DOCUSATE SODIUM AND SENNOSIDES	QUALITY CHOICE (Chain Drug Marketing Association)	72f8e8d7-ee38-4bd3-8711-f11fded0cede	2024-05-01	Warnings	Exact identifier application number: M007
Stool Softener Laxative Extra Strength	DOCUSATE SODIUM	P & L Development, LLC	c1e9863a-c229-4694-b450-6b0e0ad37503	2024-04-30	Warnings	Exact identifier application number: M007
Stool Softener Laxative	DOCUSATE SODIUM	QUALITY CHOICE (Chain Drug Marketing Association)	96c7f8bc-be95-40d1-9977-44b7cc6582df	2024-04-22	Warnings	Exact identifier application number: M007
Pedia-Lax	MAGNESIUM HYDROXIDE	C.B. Fleet Company, Inc.	975f24d8-218c-40f4-84a5-558acf34329d	2024-04-11	Warnings	Exact identifier application number: M007
Stool Softener Laxative	DOCUSATE SODIUM AND SENNOSIDES	H E B	2f9e2723-53a7-47a8-8c41-87bffc4e50dd	2024-04-09	Warnings	Exact identifier application number: M007
Senna	SENNOSIDES	H E B	d047e4e9-b8ac-498e-9fde-8af5d415edaa	2024-04-09	Warnings	Exact identifier application number: M007
Stool Softener Laxative	DOCUSATE SODIUM	H E B	5b8bcc6c-de03-4d73-a76f-6f4c371cf250	2024-04-09	Warnings	Exact identifier application number: M007
Stool Softener	DOCUSATE SODIUM	H E B	1dd2be7e-bdca-4e43-b853-3ed10b636632	2024-04-08	Warnings	Exact identifier application number: M007
Stool Softener	DOCUSATE SODIUM	Bryant Ranch Prepack	1f11cf85-b094-4ca4-8b48-2d3a9093304b	2024-04-04	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