Colace

Product NDC: 67618-101
Requested package NDC: 67618-101-01
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 1 of 43 · 858 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
SENOKOT	STANDARDIZED SENNA	A-S Medication Solutions	0c6e6bdd-9f49-4550-b60a-8f58b7c0f090	2026-09-09	Warnings	Exact identifier application number: M007
Bisacodyl	BISACODYL	KROGER COMPANY	a13a8eec-3652-8c57-e053-2995a90aaebf	2026-09-09	Warnings	Exact identifier application number: M007
Stool Softener Laxative	DOCUSATE SODIUM	TARGET Corporation	4180a35b-cc50-46ae-a100-99bb218c10ff	2026-09-09	Warnings	Exact identifier application number: M007
fiber laxative	PSYLLIUM HUSK	Raritan Pharmaceuticals Inc	22e927bd-5734-424e-8870-1aaa18f1265e	2026-09-08	Warnings	Exact identifier application number: M007
DRx Choice Fiber Therapy	METHYLCELLULOSE	RARITAN PHARMACEUTICALS INC	5e5749f7-074e-4bbc-9f33-5090e603fdb4	2026-09-08	Warnings	Exact identifier application number: M007
Bisacodyl Stimulant Laxative	BISACODYL	Raritan Pharmaceuticals Inc	b99c1a6d-3034-4822-8540-210179c06857	2026-09-08	Warnings	Exact identifier application number: M007
Daily Fiber Sugar Free	PSYLLIUM HUSK	Raritan Pharmaceuticals Inc	9c4c41d8-a2d5-4168-9e97-9f9d47fc5e63	2026-09-08	Warnings	Exact identifier application number: M007
DRx Choice Fiber Therapy	METHYLCELLULOSE	RARITAN PHARMACEUTICALS INC	56c7f197-f01a-4611-a761-cda18da6eed0	2026-09-08	Warnings	Exact identifier application number: M007
Sennosides 8.6 mg	SENNOSIDES	Morepen Bio Inc	562c9f11-0ba1-011d-e063-6394a90a604a	2026-09-05	Warnings	Exact identifier application number: M007
Epsom Salt	MAGNESIUM SULFATE	Target Corporation	87f98e6c-a3a1-4ca5-bd56-977e38f48914	2026-09-04	Warnings, Adverse reactions	Exact identifier application number: M007
Kroger Stool Softener Fruit Punch	DOCUSATE SODIUM	KROGER COMPANY	b86f8f3d-594e-466c-854a-b8bff9f7a0b8	2026-09-02	Warnings	Exact identifier application number: M007
Oil	MINERAL OIL	Atlantic Biologicals Corp.	5a82197b-281d-76c0-e063-6294a90a5746	2026-09-02	Warnings, Adverse reactions	Exact identifier application number: M007
Kroger Senna Laxative Regular Strength	SENNOSIDES	KROGER COMPANY	dbb040bb-21f9-43e8-9705-689aeee4d04c	2026-09-01	Warnings	Exact identifier application number: M007
OneLAX SENNA	SENNA	Akron Pharma Inc.	27fa8f54-ed84-4afd-8da3-8754da48643b	2026-09-01	Warnings	Exact identifier application number: M007
OneLAX Saline Laxative	MAGNESIUM CITRATE	AKRON PHARMA INC	44c87bbc-2507-4b87-a74b-02f4acb30cf4	2026-09-01	Warnings	Exact identifier application number: M007
OneLAX Saline Laxative	MAGNESIUM CITRATE	AKRON PHARMA INC	e6de00e6-dd81-4aab-af23-04fab261c6ff	2026-09-01	Warnings	Exact identifier application number: M007
EZ2Go Magnesium Citrate Saline Laxative Lemon Flavor	MAGNESIUM CITRATE	Valley Medical Products LLC	5a71e88c-d8cc-a8bb-e063-6294a90af4f7	2026-09-01	Warnings	Exact identifier application number: M007
Fiber Caplets	CALCIUM POLYCARBOPHIL	THE KROGER CO.	d6856f59-ccc3-40fc-9bf1-7a5394ed12da	2026-09-01	Warnings	Exact identifier application number: M007
Mineral Oil	MINERAL OIL	Your Military Exchanges	6025dce6-02e8-418c-a248-0b5c33ff6067	2026-08-28	Warnings, Adverse reactions	Exact identifier application number: M007
Magnesium Citrate	MAGNESIUM CITRATE	Chain Drug Marketing Association	583b64e7-e48d-6ba6-e063-6294a90ad4d7	2026-08-28	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

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	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

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