FDA.reportPublic FDA data

Colace

Product NDC
67618-111
11-digit product format
676180111
Labeler code
67618
Product ID
67618-111_ec10da1a-de65-47d1-ae30-07ad97469e73
Type
HUMAN OTC DRUG
Nonproprietary name
Docusate sodium
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
Atlantis Consumer Healthcare, Inc.
Application
M007
Marketing category
OTC MONOGRAPH DRUG
Marketing start
1900-01-07
Substance
DOCUSATE SODIUM
Active strength
50 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

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
F05Q2T2JA0Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1247759Internal RxNorm lookup
1247761Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
a1591da0-a1a9-9583-3cf5-788b8fee3814Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67618-111-10Colace100 in 1 BOTTLECAPSULE, LIQUID FILLED10010
67618-111-10Colace1 in 1 CARTONCAPSULE, LIQUID FILLED110
67618-111-28Colace1 in 1 CARTONCAPSULE, LIQUID FILLED110
67618-111-28Colace28 in 1 BOTTLECAPSULE, LIQUID FILLED2810
67618-111-42Colace42 in 1 BOTTLECAPSULE, LIQUID FILLED4210
67618-111-42Colace1 in 1 CARTONCAPSULE, LIQUID FILLED110
67618-111-60Colace60 in 1 BOTTLECAPSULE, LIQUID FILLED6010
67618-111-60Colace1 in 1 CARTONCAPSULE, LIQUID FILLED110

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
67618-111-28EA - Each67618-11183568077-dfe8-4169-b53c-57668d07162512017-06-15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67618-111COLACE (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [ATLANTIS CONSUMER HEALTHCARE, INC.]8Current NDC, Legacy NDC, 8 package rows20240113_a1591da0-a1a9-9583-3cf5-788b8fee3814.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 22 of 42 · 833 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Senna SyrupNATURAL VEGETABLE LAXATIVEMethod Pharmaceuticalsce83ba78-7e0d-b37f-e053-2995a90a93832025-10-21WarningsExact identifier
application number: M007
Fiber LaxCALCIUM POLYCARBOPHILPD-Rx Pharmaceuticals, Inc.730198a5-b6d9-4fc7-b053-a7c65a93c5402025-10-20WarningsExact identifier
application number: M007
GlycerinGLYCERINChain Drug Consortium LLC4694f05b-d927-4e15-9630-a0a1cddb3cbb2025-10-16WarningsExact identifier
application number: M007
GlycerinGLYCERINAmerisource Bergen/Good Neighbor Pharmacye6a8914f-cfd9-4c72-abaa-22189bf0faef2025-10-16WarningsExact identifier
application number: M007
GlycerinGLYCERINChain Drug Marketing Association Inc.3386fada-6b7f-46fd-e063-6294a90abffc2025-10-16WarningsExact identifier
application number: M007
Senna SyrupSENNA SYRUPKesin Pharma Corporation360fb98d-c6ad-7bcc-e063-6294a90a94532025-10-14WarningsExact identifier
application number: M007
GlycerinGLYCERINH E B3d0566a1-57a5-6a31-e054-00144ff88e882025-10-09WarningsExact identifier
application number: M007
SENNA WITH DOCUSATE SODIUMDOCUSATE SODIUM AND SENNOSIDESHHH Pharmaceuticals2bbb1b99-d43c-40a3-bc53-e18e8394c3182025-10-08WarningsExact identifier
application number: M007
Castor OilCASTOR OILBIONPHARMA INC.3f9728e8-c7a2-6cfb-e063-6394a90a8f1d2025-10-06WarningsExact identifier
application number: M007
SennosidesSENNOSIDESInvaTech Pharma Solutions LLC3de39fbd-29be-fce7-e063-6394a90a67ae2025-10-03WarningsExact identifier
application number: M007
Metamucil Therapy for regularityPSYLLIUM HUSKThe Procter & Gamble Manufacturing Companya9824f73-5ea2-4a65-a926-3a57561441b82025-10-01WarningsExact identifier
application number: M007
OneLAX SENNASENNAAtlantic Biologicals Corp.40202c76-4273-88fd-e063-6394a90a07b22025-10-01WarningsExact identifier
application number: M007
Magnesium CitrateMAGNESIUM CITRATE ORAL SOLUTIONBionpharma, Inc.4019fbd0-fcf9-77a6-e063-6294a90a5ae72025-09-30WarningsExact identifier
application number: M007
LEADER HYDROCORTISONE WITH ALOEHYDROCORTISONELEADER39916470-15bf-4bd0-96e2-b909d68cf9c42025-09-29WarningsExact identifier
application number: M007
Leader Ready to Use Mineral Oil LaxativeMINERAL OILCardinal Healthb8494d02-8a7d-47b4-80b0-b8ab51b625fd2025-09-29WarningsExact identifier
application number: M007
Leader Ready to Use Saline LaxativeSODIUM PHOSPHATE, DIBASIC AND SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORMCardinal Health1b4f9c28-0547-4922-aa15-990c6fd9dc9f2025-09-29WarningsExact identifier
application number: M007
Milk of MagnesiaMAGNESIUM HYDROXIDEKesin Pharma Corporation3f7cff50-749b-5275-e063-6394a90af4072025-09-23WarningsExact identifier
application number: M007
Stimulant Laxative Plus Stool SoftenerDOCUSATE SODIUM 50 MG AND SENNOSIDES 8.6 MGBryant Ranch Prepack12f613e4-c919-4cc4-a445-eb30039ae45f2025-09-18WarningsExact identifier
application number: M007
Saline LaxativeSALINE LAXATIVEMajor Pharmaceuticalsb3758ffe-1bac-4df6-9714-5e33e9d28d902025-09-16WarningsExact identifier
application number: M007
Gentle LaxativeBISACODYLBETTER LIVING BRANDS LLC.f29d57f6-0938-d459-e053-2995a90ad86b2025-09-13WarningsExact identifier
application number: M007

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1247761Colace 50 MG Oral CapsulePSNa1591da0-a1a9-9583-3cf5-788b8fee381410
1247759docusate sodium 50 MG Oral CapsulePSNa1591da0-a1a9-9583-3cf5-788b8fee381410
1247761docusate sodium 50 MG Oral Capsule [Colace]SBDa1591da0-a1a9-9583-3cf5-788b8fee381410
1247759docusate sodium 50 MG Oral CapsuleSCDa1591da0-a1a9-9583-3cf5-788b8fee381410
1247761Colace 50 MG Oral CapsuleSYa1591da0-a1a9-9583-3cf5-788b8fee381410
1247759DOSS Sodium 50 MG Oral CapsuleSYa1591da0-a1a9-9583-3cf5-788b8fee381410
1247761DOSS Sodium 50 MG Oral Capsule [Colace]SYa1591da0-a1a9-9583-3cf5-788b8fee381410

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67618-111-10676180111101 BOTTLE in 1 CARTON (67618-111-10) / 100 CAPSULE, LIQUID FILLED in 1 BOTTLE1 bottle2025-12-01NoNoCurrent
67618-111-28676180111281 BOTTLE in 1 CARTON (67618-111-28) / 28 CAPSULE, LIQUID FILLED in 1 BOTTLE1 bottle1900-01-070000-00-00NoNoCurrent
67618-111-42676180111421 BOTTLE in 1 CARTON (67618-111-42) / 42 CAPSULE, LIQUID FILLED in 1 BOTTLE1 bottle2024-02-01NoNoCurrent
67618-111-60676180111601 BOTTLE in 1 CARTON (67618-111-60) / 60 CAPSULE, LIQUID FILLED in 1 BOTTLE1 bottle2024-04-01NoNoCurrent