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 30 of 42 · 833 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Senna-LaxSENNOSIDESGuardian Drug Companyd3ee7288-986e-44a6-8aa2-05405210c8752024-12-19WarningsExact identifier
application number: M007
Quality Choice Stool SoftenerDOCUSATE SODIUMChain Drug Marketing Association4d5facd4-f57f-44f7-b8dd-83a33e57afd92024-12-18WarningsExact identifier
application number: M007
Good Neighbor Pharmacy Gentle LaxativeBISACODYLAmerisourceBergen Drug Corp8336d821-ec70-468e-98b2-512a9a7212e02024-12-18WarningsExact identifier
application number: M007
Good Neighbor Stool SoftenerDOCUSATE SODIUMAmerisourceBergen Drug Corp88d657a1-77be-412a-9295-034872db2dde2024-12-18WarningsExact identifier
application number: M007
Preferred Stool SoftenerDOCUSATE SODIUMReese Pharmaceutical Co217d13a0-3205-492c-af49-82eb80dba53a2024-12-18WarningsExact identifier
application number: M007
Preferred Stool SoftenerDOCUSATE CALCIUMReese Pharmaceutical Co3b481b74-5683-466f-ad74-3da63279ce912024-12-18WarningsExact identifier
application number: M007
Topcare Stool SoftenerDOCUSATE SODIUMTOPCO ASSOCIATES LLC9342c1b5-5d35-4b60-b347-c208c0774cdc2024-12-18WarningsExact identifier
application number: M007
HEB Stool SoftenerDOCUSATE SODIUMH E B3a513cb9-8404-43dc-a780-040bf9f1741d2024-12-18WarningsExact identifier
application number: M007
Topcare Stool Softener laxativeDOCUSATE SODIUMTOPCO ASSOCIATES LLCf9302fc2-684d-4cc2-bdd7-7ad0e9304edb2024-12-18WarningsExact identifier
application number: M007
Good Neighbor Stool Softener laxativeDOCUSATE SODIUMAmerisourceBergen Drug Corpd09151ae-1cc6-4e69-8d80-7813082a42362024-12-18WarningsExact identifier
application number: M007
Dollar General Gentle LaxativeBISACODYLDolgencorp, LLCf1977a2e-942a-49eb-8d0f-cdb67b020a262024-12-18WarningsExact identifier
application number: M007
Discount Drugmart Gentle LaxativeBISACODYLDiscount Drug Mart, Incb525a0a9-f97c-4406-8360-58e87e44cfce2024-12-18WarningsExact identifier
application number: M007
HEB Gentle LaxativeBISACODYLH E B3d163d71-93c7-419f-9707-5811aa6474fb2024-12-18WarningsExact identifier
application number: M007
Winco Stool SoftenerDOCUSATE SODIUMWinCo Foods, LLC4de2e315-5ec6-4ddf-8617-4e07ba4563542024-12-18WarningsExact identifier
application number: M007
Meijer Gentle LaxativeBISACODYLMeijer Distribution Inc.b49786a1-f0b9-45ae-b8f6-683489c54e762024-12-18WarningsExact identifier
application number: M007
H E B Stool Softener laxativeDOCUSATE SODIUMH E B9d848fdd-3a2f-45c6-9ff3-17f1d74e0f4f2024-12-18WarningsExact identifier
application number: M007
Preferred Stool Softener laxativeDOCUSATE SODIUMReese Pharmaceutical Co9135addd-4fc7-411b-b3c3-79e7e0e4cec82024-12-18WarningsExact identifier
application number: M007
DOCUSATE SODIUM 100mg Two-ToneDOCUSATE SODIUMDiscount Drug Mart, Inc80092188-0517-4646-bd46-ab56c63bb3542024-12-18WarningsExact identifier
application number: M007
Winco Stool SoftenerDOCUSATE SODIUMWinCo Foods, LLCd74c54d6-7a75-4ca9-8425-7593b7841b0f2024-12-18WarningsExact identifier
application number: M007
Quality Choice Stool Softener laxativeDOCUSATE SODIUMChain Drug Marketing Association7635b081-4350-45d0-b44e-82afccce21342024-12-18WarningsExact 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