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 7 of 42 · 833 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Sennosides, Docusate Sodium	SENNOSIDES, DOCUSATE SODIUM	Cardinal Health 107, LLC	1a21b07a-263c-41a4-ba0c-ad2dc5a295d7	2026-05-05	Warnings	Exact identifier application number: M007
Docusate Sodium and Sennosides	DOCUSATE SODIUM AND SENNOSIDES	SOFTGEL HEALTHCARE PRIVATE LIMITED	4842a767-bb12-9d85-e063-6294a90a19b5	2026-04-27	Warnings	Exact identifier application number: M007
Alcohol wet wipes	ALCOHOL WET WIPES	Shandong Aishule Hygiene Products Co., Ltd	f79dbac0-cec0-46bc-e053-6294a90a2b13	2026-04-25	Warnings	Exact identifier application number: M007
Sterilized wet wipes	STERILIZED WET WIPES	Shandong Aishule Hygiene Products Co., Ltd	f7ca1799-eee4-66f0-e053-6294a90a273f	2026-04-25	Warnings	Exact identifier application number: M007
Wet wipes	WET WIPES	JINGXIN GROUP (M) SDN BHD	395225b1-486b-1867-e063-6394a90a1865	2026-04-25	Warnings	Exact identifier application number: M007
Sterilized wet wipes	STERILIZED WET WIPES	JINGXIN GROUP (M) SDN BHD	3952873e-5e3f-1bff-e063-6294a90a8a62	2026-04-25	Warnings	Exact identifier application number: M007
Stool Softener Laxative	DOCUSATE SODIUM	Publix Supermarkets, Inc.	ed50555f-b105-45c8-9dc4-1bd4d233a1e3	2026-04-23	Warnings	Exact identifier application number: M007
Mineral Oil	MINERAL OIL	Publix Supermarkets, Inc.	382a57d1-85bf-480f-9967-f85da2904410	2026-04-23	Warnings	Exact identifier application number: M007
BISACODYL	BISACODYL	AARNA USA INC.	50109967-69af-5fc5-e063-6394a90a8751	2026-04-22	Warnings	Exact identifier application number: M007
Senna	SENNA	Rugby Laboratories	41d53783-7ac2-411c-b9bf-afd87b3af30d	2026-04-18	Warnings	Exact identifier application number: M007
Stool Softener Laxative	DOCUSATE SODIUM	United Natural Foods, Inc. dba UNFI	95bae7bf-f240-4674-9e3c-640a603fdc35	2026-04-15	Warnings	Exact identifier application number: M007
Magnesium Citrate	MAGNESIUM CITRATE	Publix Super Markets, Inc.	a4b442f1-d5a6-4cbf-b371-1f6639634f80	2026-04-13	Warnings, Adverse reactions	Exact identifier application number: M007
Magnesium Citrate	MAGNESIUM CITRATE	Publix Super Markets, Inc.	267c434d-3034-491b-b4b1-1d0cbacb1615	2026-04-13	Warnings, Adverse reactions	Exact identifier application number: M007
Stool Softener Laxative	DOCUSATE SODIUM	Bryant Ranch Prepack	d616685a-11fc-4ae0-80de-7d25c0d71ee9	2026-04-09	Warnings	Exact identifier application number: M007
Stool Softener Laxative	DOCUSATE SODIUM	H E B	84116db2-a7b7-460a-a5e5-8558bd424781	2026-04-02	Warnings	Exact identifier application number: M007
MILK OF MAGNESIA ORIGINAL	MAGNESIUM HYDROXIDE	American Health Packaging	7d7d789b-b2e7-4600-a025-0cd2ff5b3672	2026-04-02	Warnings	Exact identifier application number: M007
Castor Oil	CASTOR OIL	STRATEGIC SOURCING SERVICES	4db6736f-416a-f142-e063-6394a90ab08f	2026-04-01	Warnings	Exact identifier application number: M007
Magnesium Citrate	MAGNESIUM CITRATE	Farmacias De Similares TX LLC	4e6a64a0-e453-709b-e063-6294a90a7443	2026-04-01	Warnings	Exact identifier application number: M007
Stool Softener Laxative	DOCUSATE SODIUM	Major Pharmaceuticals	93ef6486-0930-41e3-a2c6-44af7e37e98b	2026-03-31	Warnings	Exact identifier application number: M007
Senna Syrup	NATURAL VEGETABLE LAXATIVE	Bryant Ranch Prepack	2c0d62e7-563b-46e4-9793-183e98e761a6	2026-03-25	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