Colace

Product NDC: 67618-110
11-digit product format: 676180110
Labeler code: 67618
Product ID: 67618-110_43b34e61-b03f-47a7-bbe7-56022f7e521a
Type: HUMAN OTC DRUG
Nonproprietary name: Docusate sodium - sennosides
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Atlantis Consumer Healthcare, Inc.
Application: M007
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 1957-02-08
Substance: DOCUSATE SODIUM; SENNOSIDES
Active strength: 50; 8.6 mg/1; 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
SENNOSIDES	8.6 mg/1

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
67618-110-10	Colace	2 in 1 CARTON	TABLET, FILM COATED	2	8
67618-110-10	Colace	5 in 1 BLISTER PACK	TABLET, FILM COATED	5	8
67618-110-12	Colace	2 in 1 PACKAGE	TABLET, FILM COATED	2	8
67618-110-12	Colace	1 in 1 CARTON	TABLET, FILM COATED	1	8
67618-110-30	Colace	1 in 1 CARTON	TABLET, FILM COATED	1	8
67618-110-30	Colace	30 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	30	8
67618-110-60	Colace	1 in 1 CARTON	TABLET, FILM COATED	1	8
67618-110-60	Colace	60 in 1 BOTTLE, PLASTIC	TABLET, FILM COATED	60	8

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
67618-110-10	EA - Each	67618-110	97f64826-6da0-4225-8a8c-fd5c79f1d290	1	2017-06-15
67618-110-30	EA - Each	67618-110	cc0b7afb-4dbc-4de0-9baf-f0a11bf2e3c2	1	2017-06-15
67618-110-60	EA - Each	67618-110	8ed23b60-d6db-4138-9d8d-ba01cc4db8ec	1	2017-06-15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
67618-110	COLACE (DOCUSATE SODIUM - SENNOSIDES) TABLET, FILM COATED [ATLANTIS CONSUMER HEALTHCARE, INC.]	8	Current NDC, Legacy NDC, 8 package rows	20250419_9fce5c4b-1e2e-47ef-13e5-c3bd5320d41b.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
3FYP5M0IJX	SENNOSIDES		SENNOSIDES

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1872920	Colace w/Sennosides 50 MG / 8.6 MG Oral Tablet	PSN	9fce5c4b-1e2e-47ef-13e5-c3bd5320d41b	8
998740	sennosides 8.6 MG / docusate sodium 50 MG Oral Tablet	PSN	9fce5c4b-1e2e-47ef-13e5-c3bd5320d41b	8
1872920	docusate sodium 50 MG / sennosides, USP 8.6 MG Oral Tablet [Colace w/Sennosides]	SBD	9fce5c4b-1e2e-47ef-13e5-c3bd5320d41b	8
998740	docusate sodium 50 MG / sennosides, USP 8.6 MG Oral Tablet	SCD	9fce5c4b-1e2e-47ef-13e5-c3bd5320d41b	8
1872920	Colace w/Sennosides (docusate sodium 50 MG / sennosides, USP 8.6 MG) Oral Tablet	SY	9fce5c4b-1e2e-47ef-13e5-c3bd5320d41b	8
998740	DOSS Sodium 50 MG / sennosides, USP 8.6 MG Oral Tablet	SY	9fce5c4b-1e2e-47ef-13e5-c3bd5320d41b	8
1872920	DOSS Sodium 50 MG / sennosides, USP 8.6 MG Oral Tablet [Colace w/Sennosides]	SY	9fce5c4b-1e2e-47ef-13e5-c3bd5320d41b	8

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
67618-110-10	67618011010	2 BLISTER PACK in 1 CARTON (67618-110-10) / 5 TABLET, FILM COATED in 1 BLISTER PACK	2 blister pack	1957-02-08	0000-00-00	No	No	Current
67618-110-12	67618011012	2 in 1 PACKAGE						Historical
67618-110-30	67618011030	1 BOTTLE, PLASTIC in 1 CARTON (67618-110-30) / 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC		1957-02-08	0000-00-00	No	No	Current
67618-110-60	67618011060	1 BOTTLE, PLASTIC in 1 CARTON (67618-110-60) / 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC		1957-02-08	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Colace	Atlantis Consumer Healthcare, Inc.	2026-09-09	HUMAN OTC DRUG LABEL	9
Colace 2-in-1	ATLANTIS CONSUMER HEALTHCARE INC \| Purdue Pharma LP \| Contract Pharmacal Corporation \| P&L Development, LLC \| Patheon Softgels Inc.	2023-12-22	HUMAN OTC DRUG LABEL	2