FDA.reportPublic FDA data

Colace

Product NDC
67618-110
11-digit product format
676180110
Labeler code
67618
Product ID
67618-110_33014ecb-19a8-ecec-e063-6294a90a7ab0
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Colace
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DOCUSATE SODIUM50 mg/1
SENNOSIDES8.6 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiF05Q2T2JA0, 3FYP5M0IJX
Rxcui998740, 1872920

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

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 CARTON in 1 PACKAGE (67618-110-12) / 1 BOTTLE, PLASTIC in 1 CARTON / 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC2 carton2024-01-01NoNoCurrent
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