Colace

Product NDC: 67618-101
11-digit product format: 676180101
Labeler code: 67618
Product ID: 67618-101_650714ee-2cec-42c9-8631-b3f8ebc7348f
Type: HUMAN OTC DRUG
Nonproprietary name: Docusate sodium
Dosage form: CAPSULE
Route: ORAL
Labeler: Atlantis Consumer Healthcare, Inc.
Application: M007
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 1997-01-30
Substance: DOCUSATE SODIUM
Active strength: 100 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	100 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
1115005	Internal RxNorm lookup
1247756	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
7793fced-e8ee-44e2-b212-dd2a59a5f462	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
67618-101-01	Colace	1 in 1 CARTON	CAPSULE	1	13
67618-101-01	Colace	100 in 1 BOTTLE, PLASTIC	CAPSULE	100	13
67618-101-10	Colace	2 in 1 CARTON	CAPSULE	2	13
67618-101-10	Colace	5 in 1 BLISTER PACK	CAPSULE	5	13
67618-101-30	Colace	1 in 1 CARTON	CAPSULE	1	13
67618-101-30	Colace	30 in 1 BOTTLE, PLASTIC	CAPSULE	30	13
67618-101-51	Colace	150 in 1 BOTTLE, PLASTIC	CAPSULE	150	13
67618-101-52	Colace	250 in 1 BOTTLE, PLASTIC	CAPSULE	250	13
67618-101-60	Colace	60 in 1 BOTTLE, PLASTIC	CAPSULE	60	13
67618-101-60	Colace	1 in 1 CARTON	CAPSULE	1	13

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
67618-101-01	EA - Each	67618-101	f2ec6fdd-0022-4ae9-9cb1-1283a1d2759b	1	2022-03-09
67618-101-10	EA - Each	67618-101	676d3b90-74ba-48c7-af2d-57967b4b5890	1	2013-02-13
67618-101-30	EA - Each	67618-101	31b331a1-c148-43af-8b5b-a8c2e1bca3e0	1	2012-07-24
67618-101-52	EA - Each	67618-101	fa2dae37-1524-44fa-88c8-abc6ffaa91f1	1	2012-07-24
67618-101-60	EA - Each	67618-101	019c7bf6-c568-44be-8113-3fe6d46ce305	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Docusate sodium	ACTIVE INGREDIENT	F05Q2T2JA0	COLACE (DOCUSATE SODIUM) CAPSULE [PURDUE PRODUCTS LP]	2
docusate	ACTIVE MOIETY	M7P27195AG	COLACE (DOCUSATE SODIUM) CAPSULE [PURDUE PRODUCTS LP]	2
D&C RED NO. 33	INACTIVE INGREDIENT	9DBA0SBB0L	COLACE (DOCUSATE SODIUM) CAPSULE [PURDUE PRODUCTS LP]	2
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	COLACE (DOCUSATE SODIUM) CAPSULE [PURDUE PRODUCTS LP]	2
GELATIN	INACTIVE INGREDIENT	2G86QN327L	COLACE (DOCUSATE SODIUM) CAPSULE [PURDUE PRODUCTS LP]	2
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	COLACE (DOCUSATE SODIUM) CAPSULE [PURDUE PRODUCTS LP]	2
POLYETHYLENE GLYCOL 400	INACTIVE INGREDIENT	B697894SGQ	COLACE (DOCUSATE SODIUM) CAPSULE [PURDUE PRODUCTS LP]	2
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	COLACE (DOCUSATE SODIUM) CAPSULE [PURDUE PRODUCTS LP]	2
SORBITOL	INACTIVE INGREDIENT	506T60A25R	COLACE (DOCUSATE SODIUM) CAPSULE [PURDUE PRODUCTS LP]	2
docusate sodium	ACTIVE INGREDIENT	F05Q2T2JA0	COLACE (DOCUSATE SODIUM) CAPSULE [PHYSICIANS TOTAL CARE, INC.]	1
docusate	ACTIVE MOIETY	M7P27195AG	COLACE (DOCUSATE SODIUM) CAPSULE [PHYSICIANS TOTAL CARE, INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
67618-101	COLACE (DOCUSATE SODIUM) CAPSULE [ATLANTIS CONSUMER HEALTHCARE, INC.]	13	Current NDC, Legacy NDC, 10 package rows	20250228_7793fced-e8ee-44e2-b212-dd2a59a5f462.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 10 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	Better Living Brands, LLC	7f2f1b30-497a-4c53-accc-8455169b17b3	2026-02-24	Warnings, Adverse reactions	Exact identifier application number: M007
citroma	MAGNESIUM CITRATE	Family Dollar Stores, Inc	cc97cfb5-cd40-4589-942a-5bee611a2812	2026-02-24	Warnings, Adverse reactions	Exact identifier application number: M007
citroma	MAGNESIUM CITRATE	Family Dollar Stores, Inc	0ac1896d-7ed9-44e5-bf07-147826237273	2026-02-24	Warnings, Adverse reactions	Exact identifier application number: M007
Castor Oil	CASTOR OIL	Chain Drug Marketing Association	4a003bb1-425d-cd97-e063-6294a90a5dda	2026-02-23	Warnings, Adverse reactions	Exact identifier application number: M007
citroma	MAGNESIUM CITRATE	Better Living Brands, LLC	d8176ef6-cc68-4185-b5eb-e887562f6aaa	2026-02-23	Warnings, Adverse reactions	Exact identifier application number: M007
citroma	MAGNESIUM CITRATE	Better Living Brands, LLC	07732845-c9ce-47bb-8b63-36a3d5ddf8b7	2026-02-23	Warnings, Adverse reactions	Exact identifier application number: M007
stimulant laxative	BISACODYL	BIONPHARMA INC.	4b1f7db3-c6a8-7f6a-e063-6394a90a5829	2026-02-22	Warnings	Exact identifier application number: M007
Castor Oil	CASTOR OIL	Nice-Pak Products, LLC	ff6c8022-9522-4eae-b8ff-994ee37fba06	2026-02-19	Warnings, Adverse reactions	Exact identifier application number: M007
Castor Oil	CASTOR OIL	Perrigo Direct, Inc	09e32476-1c60-4f1e-a51c-5fab2e744b30	2026-02-19	Warnings, Adverse reactions	Exact identifier application number: M007
citroma	MAGESIUM CITRATE	Perrigo Direct, Inc	22991685-8228-41e1-a13e-f57961e8dd0e	2026-02-19	Warnings, Adverse reactions	Exact identifier application number: M007
citroma	MAGESIUM CITRATE	Perrigo Direct, Inc	24478279-9a11-4e12-956d-57dc7debf941	2026-02-19	Warnings, Adverse reactions	Exact identifier application number: M007
Mineral Oil	MINERAL OIL	Perrigo Direct, Inc	f1656280-fad9-4922-9d5c-be774a8b1422	2026-02-19	Warnings, Adverse reactions	Exact identifier application number: M007
Epsom Salt	MAGNESIUM SULFATE	Meijer, Inc.	3b8eae67-9e27-46bd-ab2b-02c719786bab	2026-02-19	Warnings, Adverse reactions	Exact identifier application number: M007
Castor Oil	CASTOR OIL	Meijer, Inc.	c4d03837-193b-4817-8b78-fbdfb9122f19	2026-02-19	Warnings, Adverse reactions	Exact identifier application number: M007
Epsom Salt	MAGNESIUM SULFATE	Meijer, Inc.	2070a4a6-7968-49f2-84ec-53bd1cd82445	2026-02-19	Warnings, Adverse reactions	Exact identifier application number: M007
Mineral Oil	MINERAL OIL	Meijer, Inc.	652d1da9-a71f-4113-9ef3-da0916724625	2026-02-19	Warnings, Adverse reactions	Exact identifier application number: M007
SENNA-S	DOCUSATE SODIUM AND SENNOSIDES	Advanced Rx LLC	d148be81-79b4-41f7-b8d8-a0e85b661592	2026-02-18	Warnings	Exact identifier application number: M007
citroma	MAGNESIUM CITRATE	Target Corporation	a8e52a22-7c30-40c0-8f78-523775743bfb	2026-02-18	Warnings, Adverse reactions	Exact identifier application number: M007
Mineral Oil	MINERAL OIL	Target Corporation	526508f0-e908-4e3d-88f5-404a95f6de76	2026-02-18	Warnings, Adverse reactions	Exact identifier application number: M007
CVS Pharmacy	SALINE LAXATIVE	CVS Pharmacy	edd58c52-18de-4ec4-aec3-44f3e17607a7	2026-02-17	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
1247756	Colace 100 MG Oral Capsule	PSN	a6ffb144-0679-4702-8d97-7a78e176911e	1
1115005	docusate sodium 100 MG Oral Capsule	PSN	a6ffb144-0679-4702-8d97-7a78e176911e	1
1247756	docusate sodium 100 MG Oral Capsule [Colace]	SBD	a6ffb144-0679-4702-8d97-7a78e176911e	1
1115005	docusate sodium 100 MG Oral Capsule	SCD	a6ffb144-0679-4702-8d97-7a78e176911e	1
1247756	Colace 100 MG Oral Capsule	SY	a6ffb144-0679-4702-8d97-7a78e176911e	1
1115005	DOSS Sodium 100 MG Oral Capsule	SY	a6ffb144-0679-4702-8d97-7a78e176911e	1
1247756	DOSS Sodium 100 MG Oral Capsule [Colace]	SY	a6ffb144-0679-4702-8d97-7a78e176911e	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
67618-101-01	67618010101	1 BOTTLE, PLASTIC in 1 CARTON (67618-101-01) / 100 CAPSULE in 1 BOTTLE, PLASTIC		2022-01-17	0000-00-00	No	No	Current
67618-101-10	67618010110	2 BLISTER PACK in 1 CARTON (67618-101-10) / 5 CAPSULE in 1 BLISTER PACK	2 blister pack	1997-01-30	0000-00-00	No	No	Current
67618-101-25	67618010125	250 CAPSULE in 1 BOTTLE, PLASTIC (67618-101-25)	250 capsule	2026-05-27		No	No	Current
67618-101-30	67618010130	1 BOTTLE, PLASTIC in 1 CARTON (67618-101-30) / 30 CAPSULE in 1 BOTTLE, PLASTIC		1997-01-30	0000-00-00	No	No	Current
67618-101-51	67618010151	150 CAPSULE in 1 BOTTLE, PLASTIC (67618-101-51)	150 capsule	2025-02-28		No	No	Current
67618-101-52	67618010152	250 CAPSULE in 1 BOTTLE, PLASTIC (67618-101-52)	250 capsule	1997-01-30	2028-09-30	No	No	Current
67618-101-60	67618010160	1 BOTTLE, PLASTIC in 1 CARTON (67618-101-60) / 60 CAPSULE in 1 BOTTLE, PLASTIC		1997-01-30	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Colace - Atlantis Consumer Healthcare, Inc.	Atlantis Consumer Healthcare, Inc.	2026-08-04	HUMAN OTC DRUG LABEL	18
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
Colace - REMEDYREPACK INC.	REMEDYREPACK INC.	2022-01-05	HUMAN OTC DRUG LABEL	1
Colace 50 mg	Physicians Total Care, Inc.	2010-03-29	HUMAN OTC DRUG LABEL	1