FDA.reportPublic FDA data

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
IngredientStrength
DOCUSATE SODIUM50 mg/1
SENNOSIDES8.6 mg/1

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67618-110-10Colace2 in 1 CARTONTABLET, FILM COATED28
67618-110-10Colace5 in 1 BLISTER PACKTABLET, FILM COATED58
67618-110-12Colace2 in 1 PACKAGETABLET, FILM COATED28
67618-110-12Colace1 in 1 CARTONTABLET, FILM COATED18
67618-110-30Colace1 in 1 CARTONTABLET, FILM COATED18
67618-110-30Colace30 in 1 BOTTLE, PLASTICTABLET, FILM COATED308
67618-110-60Colace1 in 1 CARTONTABLET, FILM COATED18
67618-110-60Colace60 in 1 BOTTLE, PLASTICTABLET, FILM COATED608

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
67618-110-10EA - Each67618-11097f64826-6da0-4225-8a8c-fd5c79f1d29012017-06-15
67618-110-30EA - Each67618-110cc0b7afb-4dbc-4de0-9baf-f0a11bf2e3c212017-06-15
67618-110-60EA - Each67618-1108ed23b60-d6db-4138-9d8d-ba01cc4db8ec12017-06-15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67618-110COLACE (DOCUSATE SODIUM - SENNOSIDES) TABLET, FILM COATED [ATLANTIS CONSUMER HEALTHCARE, INC.]8Current NDC, Legacy NDC, 8 package rows20250419_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 42 of 42 · 833 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Stool Softener Extra StrengthDOCUSATE SODIUMMEIJER, INC.e43bd2ed-17c7-4530-af72-81a7ad70069c2023-10-12WarningsExact identifier
application number: M007
Stool Softener Plus Stimulant LaxativeDOCUSATE SODIUM AND SENNOSIDESCare One (Retail Business Services, LLC.)9adaec97-43e3-48f2-96c8-c508b693676c2023-10-05WarningsExact identifier
application number: M007
Senna LaxSENNOSIDES 8.6MGTopCo Associates, LLC83aeb90a-ab00-4e26-aa44-5259dce590182021-04-28WarningsExact identifier
application number: M007
Stool SoftenerDOCUSATE SODIUMAllegiant Health9fbe783e-ddd9-445a-852a-00f4ad7548802021-04-20WarningsExact identifier
application number: M007
Topcare Stool SoftenerDOCUSATE SODIUMTopCo Associates, LLC6f4fddda-4129-4087-b0e4-ababc55584842021-02-19WarningsExact identifier
application number: M007
Stool SoftenerDOCUSATE SODIUMAllegiant Health30c9ff75-cee4-4632-86fd-acfdf5ee85af2020-10-27WarningsExact identifier
application number: M007
Stool SoftenerMARC GLASSMANMarc Glassman, Inc.909cd222-d836-416f-aa7d-deb4a0c5a5602020-09-08WarningsExact identifier
application number: M007
Senna LaxSENNOSIDES 8.6MGAllegiant Health94a9c24a-07c3-4535-b810-b7abc9fc5ad52019-12-11WarningsExact identifier
application number: M007
Laxative Enteric CoatedBISACODYL 5MGMarc Glassman, Inc.ec34fc1e-d122-4fa4-859e-e89e3e12edd52019-09-18WarningsExact identifier
application number: M007
Womens LaxativeBISACODYLMarc Glassman, Inc.aeb3c49b-cbf5-4a47-b19c-e77fbb987a492019-09-17WarningsExact identifier
application number: M007
Bisacodyl 5mgBISACODYL 5MGAllegiant Health46a377f5-822b-496f-a73b-66d8f902680a2019-03-26WarningsExact identifier
application number: M007
Laxative Enteric CoatedBISACODYL 5MGAllegiant Health51f1c6c0-770c-4426-820b-bc1f42e143fd2019-02-07WarningsExact identifier
application number: M007
Senna-LaxSENNOSIDESMarc Glassman, Inc.7dd97c54-2ba1-4629-87b9-1ba0913fe5312016-12-27WarningsExact identifier
application number: M007

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1872920Colace w/Sennosides 50 MG / 8.6 MG Oral TabletPSN9fce5c4b-1e2e-47ef-13e5-c3bd5320d41b8
998740sennosides 8.6 MG / docusate sodium 50 MG Oral TabletPSN9fce5c4b-1e2e-47ef-13e5-c3bd5320d41b8
1872920docusate sodium 50 MG / sennosides, USP 8.6 MG Oral Tablet [Colace w/Sennosides]SBD9fce5c4b-1e2e-47ef-13e5-c3bd5320d41b8
998740docusate sodium 50 MG / sennosides, USP 8.6 MG Oral TabletSCD9fce5c4b-1e2e-47ef-13e5-c3bd5320d41b8
1872920Colace w/Sennosides (docusate sodium 50 MG / sennosides, USP 8.6 MG) Oral TabletSY9fce5c4b-1e2e-47ef-13e5-c3bd5320d41b8
998740DOSS Sodium 50 MG / sennosides, USP 8.6 MG Oral TabletSY9fce5c4b-1e2e-47ef-13e5-c3bd5320d41b8
1872920DOSS Sodium 50 MG / sennosides, USP 8.6 MG Oral Tablet [Colace w/Sennosides]SY9fce5c4b-1e2e-47ef-13e5-c3bd5320d41b8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67618-110-10676180110102 BLISTER PACK in 1 CARTON (67618-110-10) / 5 TABLET, FILM COATED in 1 BLISTER PACK2 blister pack1957-02-080000-00-00NoNoCurrent
67618-110-12676180110122 in 1 PACKAGEHistorical
67618-110-30676180110301 BOTTLE, PLASTIC in 1 CARTON (67618-110-30) / 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC1957-02-080000-00-00NoNoCurrent
67618-110-60676180110601 BOTTLE, PLASTIC in 1 CARTON (67618-110-60) / 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC1957-02-080000-00-00NoNoCurrent