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 26 of 42 · 833 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Womens Gentle LaxativeBISACODYLBETTER LIVING BRANDS LLC.f2c4ed1a-5aa4-1915-e053-2a95a90a59b62025-02-12WarningsExact identifier
application number: M007
LaxativeSENNOSIDESBETTER LIVING BRANDS LLC.f2c5c1e6-3123-c802-e053-2995a90aa0732025-02-12WarningsExact identifier
application number: M007
Vegetable LaxativeSENNOSIDESBETTER LIVING BRANDS LLC.f2c529e4-6738-377c-e053-2995a90aaf382025-02-12WarningsExact identifier
application number: M007
WOMENS GENTLE LAXATIVEBISACODYLCVS HEALTH CORPa95073f3-e1d6-d291-e053-2a95a90aefea2025-02-12WarningsExact identifier
application number: M007
MAXIMUM STRENGTH LAXATIVESENNOSIDESCVS HEALTHb05ee52f-4801-d4ca-e053-2995a90af3482025-02-12WarningsExact identifier
application number: M007
SENNASENNOSIDESReliable 1 Laboratories LLCc8aa7ae9-7d00-db7d-e053-2995a90ae72b2025-02-11WarningsExact identifier
application number: M007
Extra Gentle LaxativeBISACODYLDOLGENCORP INCbe214c4e-f6db-cc8d-e053-2a95a90addf72025-02-10WarningsExact identifier
application number: M007
SENNA-SDOCUSATE SODIUM AND SENNOSIDESKROGERa187045c-c9d6-592a-e053-2995a90adb832025-02-10WarningsExact identifier
application number: M007
SENNA TIMESENNOSIDESTIME CAP LABORATORIES, INC18ec8127-422c-4c1a-8331-58dabce699692025-02-08WarningsExact identifier
application number: M007
SENNA TIME SDOCUSATE SODIUM-SENNOSIDESTIME CAP LABORATORIES, INCdc491692-8d3a-4ccd-a17d-4c630f1225952025-02-08WarningsExact identifier
application number: M007
LAX-TIMESENNOSIDESTIME CAP LABORATORIES, INC74a627fc-00e5-eb78-e053-2991aa0abacc2025-02-08WarningsExact identifier
application number: M007
SENNOSIDES AND DOCUSATE SODIUMSENNOSIDES AND DOCUSATE SODIUMTIME CAP LABORATORIES, INC0ad617e0-10a6-44fa-be62-4f3cc725fb012025-02-08WarningsExact identifier
application number: M007
Sennosides and Docusate SodiumSENNOSIDES, DOCUSATE SODIUMAsclemed USA, Inc.2db546de-20dc-4697-aff2-12471f073b1d2025-02-08WarningsExact identifier
application number: M007
SENNOSIDESSENNOSIDESTIME CAP LABORATORIES, INC7498f5fa-1739-bb6e-e053-2a91aa0a54042025-02-07WarningsExact identifier
application number: M007
Gentle LaxativeMAGNESIUM HYDROXIDEWALMART INC.26b9f247-c242-2925-e063-6394a90a68dd2025-02-06WarningsExact identifier
application number: M007
Docusate SodiumDOCUSATE SODIUMPAI Holdings, LLC dba PAI Pharmae975a3f1-0e1f-4fb8-9c5f-baa75e12f2a52025-02-06WarningsExact identifier
application number: M007
Docusate SodiumDOCUSATE SODIUMPD-Rx Pharmaceuticals, Inc.6a7e4193-22d2-491e-9842-5c43f571fc652025-02-05WarningsExact identifier
application number: M007
Mineral oilMINERAL OILBest Choice (Valu Merchandisers Company)3ec8a716-60e0-4dfb-adae-ddc53c6139352025-02-04WarningsExact identifier
application number: M007
DOCUSATE SODIUM 50MG SOFTGEL (RED)DOCUSATE SODIUMCVS Pharmacy273e5b52-1cf9-2525-e063-6394a90a8b4f2025-02-04WarningsExact identifier
application number: M007
LaxativeSENNOSIDESWALGREENSf0caba1d-0c09-8496-e053-2995a90a47cf2025-01-30WarningsExact 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