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 22 of 42 · 833 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Senna Syrup	NATURAL VEGETABLE LAXATIVE	Method Pharmaceuticals	ce83ba78-7e0d-b37f-e053-2995a90a9383	2025-10-21	Warnings	Exact identifier application number: M007
Fiber Lax	CALCIUM POLYCARBOPHIL	PD-Rx Pharmaceuticals, Inc.	730198a5-b6d9-4fc7-b053-a7c65a93c540	2025-10-20	Warnings	Exact identifier application number: M007
Glycerin	GLYCERIN	Chain Drug Consortium LLC	4694f05b-d927-4e15-9630-a0a1cddb3cbb	2025-10-16	Warnings	Exact identifier application number: M007
Glycerin	GLYCERIN	Amerisource Bergen/Good Neighbor Pharmacy	e6a8914f-cfd9-4c72-abaa-22189bf0faef	2025-10-16	Warnings	Exact identifier application number: M007
Glycerin	GLYCERIN	Chain Drug Marketing Association Inc.	3386fada-6b7f-46fd-e063-6294a90abffc	2025-10-16	Warnings	Exact identifier application number: M007
Senna Syrup	SENNA SYRUP	Kesin Pharma Corporation	360fb98d-c6ad-7bcc-e063-6294a90a9453	2025-10-14	Warnings	Exact identifier application number: M007
Glycerin	GLYCERIN	H E B	3d0566a1-57a5-6a31-e054-00144ff88e88	2025-10-09	Warnings	Exact identifier application number: M007
SENNA WITH DOCUSATE SODIUM	DOCUSATE SODIUM AND SENNOSIDES	HHH Pharmaceuticals	2bbb1b99-d43c-40a3-bc53-e18e8394c318	2025-10-08	Warnings	Exact identifier application number: M007
Castor Oil	CASTOR OIL	BIONPHARMA INC.	3f9728e8-c7a2-6cfb-e063-6394a90a8f1d	2025-10-06	Warnings	Exact identifier application number: M007
Sennosides	SENNOSIDES	InvaTech Pharma Solutions LLC	3de39fbd-29be-fce7-e063-6394a90a67ae	2025-10-03	Warnings	Exact identifier application number: M007
Metamucil Therapy for regularity	PSYLLIUM HUSK	The Procter & Gamble Manufacturing Company	a9824f73-5ea2-4a65-a926-3a57561441b8	2025-10-01	Warnings	Exact identifier application number: M007
OneLAX SENNA	SENNA	Atlantic Biologicals Corp.	40202c76-4273-88fd-e063-6394a90a07b2	2025-10-01	Warnings	Exact identifier application number: M007
Magnesium Citrate	MAGNESIUM CITRATE ORAL SOLUTION	Bionpharma, Inc.	4019fbd0-fcf9-77a6-e063-6294a90a5ae7	2025-09-30	Warnings	Exact identifier application number: M007
LEADER HYDROCORTISONE WITH ALOE	HYDROCORTISONE	LEADER	39916470-15bf-4bd0-96e2-b909d68cf9c4	2025-09-29	Warnings	Exact identifier application number: M007
Leader Ready to Use Mineral Oil Laxative	MINERAL OIL	Cardinal Health	b8494d02-8a7d-47b4-80b0-b8ab51b625fd	2025-09-29	Warnings	Exact identifier application number: M007
Leader Ready to Use Saline Laxative	SODIUM PHOSPHATE, DIBASIC AND SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM	Cardinal Health	1b4f9c28-0547-4922-aa15-990c6fd9dc9f	2025-09-29	Warnings	Exact identifier application number: M007
Milk of Magnesia	MAGNESIUM HYDROXIDE	Kesin Pharma Corporation	3f7cff50-749b-5275-e063-6394a90af407	2025-09-23	Warnings	Exact identifier application number: M007
Stimulant Laxative Plus Stool Softener	DOCUSATE SODIUM 50 MG AND SENNOSIDES 8.6 MG	Bryant Ranch Prepack	12f613e4-c919-4cc4-a445-eb30039ae45f	2025-09-18	Warnings	Exact identifier application number: M007
Saline Laxative	SALINE LAXATIVE	Major Pharmaceuticals	b3758ffe-1bac-4df6-9714-5e33e9d28d90	2025-09-16	Warnings	Exact identifier application number: M007
Gentle Laxative	BISACODYL	BETTER LIVING BRANDS LLC.	f29d57f6-0938-d459-e053-2995a90ad86b	2025-09-13	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
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