FDA.reportPublic FDA data

Colace

Product NDC
67618-101
11-digit product format
676180101
Labeler code
67618
Product ID
67618-101_650714ee-2cec-42c9-8631-b3f8ebc7348f
Type
HUMAN OTC DRUG
Nonproprietary name
Docusate sodium
Dosage form
CAPSULE
Route
ORAL
Labeler
Atlantis Consumer Healthcare, Inc.
Application
M007
Marketing category
OTC MONOGRAPH DRUG
Marketing start
1997-01-30
Substance
DOCUSATE SODIUM
Active strength
100 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 SODIUM100 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
1115005Internal RxNorm lookup
1247756Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
7793fced-e8ee-44e2-b212-dd2a59a5f462Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67618-101-01Colace1 in 1 CARTONCAPSULE113
67618-101-01Colace100 in 1 BOTTLE, PLASTICCAPSULE10013
67618-101-10Colace2 in 1 CARTONCAPSULE213
67618-101-10Colace5 in 1 BLISTER PACKCAPSULE513
67618-101-30Colace1 in 1 CARTONCAPSULE113
67618-101-30Colace30 in 1 BOTTLE, PLASTICCAPSULE3013
67618-101-51Colace150 in 1 BOTTLE, PLASTICCAPSULE15013
67618-101-52Colace250 in 1 BOTTLE, PLASTICCAPSULE25013
67618-101-60Colace60 in 1 BOTTLE, PLASTICCAPSULE6013
67618-101-60Colace1 in 1 CARTONCAPSULE113

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
67618-101-01EA - Each67618-101f2ec6fdd-0022-4ae9-9cb1-1283a1d2759b12022-03-09
67618-101-10EA - Each67618-101676d3b90-74ba-48c7-af2d-57967b4b589012013-02-13
67618-101-30EA - Each67618-10131b331a1-c148-43af-8b5b-a8c2e1bca3e012012-07-24
67618-101-52EA - Each67618-101fa2dae37-1524-44fa-88c8-abc6ffaa91f112012-07-24
67618-101-60EA - Each67618-101019c7bf6-c568-44be-8113-3fe6d46ce30512012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Docusate sodiumACTIVE INGREDIENTF05Q2T2JA0COLACE (DOCUSATE SODIUM) CAPSULE [PURDUE PRODUCTS LP]2
docusateACTIVE MOIETYM7P27195AGCOLACE (DOCUSATE SODIUM) CAPSULE [PURDUE PRODUCTS LP]2
D&C RED NO. 33INACTIVE INGREDIENT9DBA0SBB0LCOLACE (DOCUSATE SODIUM) CAPSULE [PURDUE PRODUCTS LP]2
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOACOLACE (DOCUSATE SODIUM) CAPSULE [PURDUE PRODUCTS LP]2
GELATININACTIVE INGREDIENT2G86QN327LCOLACE (DOCUSATE SODIUM) CAPSULE [PURDUE PRODUCTS LP]2
GLYCERININACTIVE INGREDIENTPDC6A3C0OXCOLACE (DOCUSATE SODIUM) CAPSULE [PURDUE PRODUCTS LP]2
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQCOLACE (DOCUSATE SODIUM) CAPSULE [PURDUE PRODUCTS LP]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3COLACE (DOCUSATE SODIUM) CAPSULE [PURDUE PRODUCTS LP]2
SORBITOLINACTIVE INGREDIENT506T60A25RCOLACE (DOCUSATE SODIUM) CAPSULE [PURDUE PRODUCTS LP]2
docusate sodiumACTIVE INGREDIENTF05Q2T2JA0COLACE (DOCUSATE SODIUM) CAPSULE [PHYSICIANS TOTAL CARE, INC.]1
docusateACTIVE MOIETYM7P27195AGCOLACE (DOCUSATE SODIUM) CAPSULE [PHYSICIANS TOTAL CARE, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67618-101COLACE (DOCUSATE SODIUM) CAPSULE [ATLANTIS CONSUMER HEALTHCARE, INC.]13Current NDC, Legacy NDC, 10 package rows20250228_7793fced-e8ee-44e2-b212-dd2a59a5f462.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 4 of 43 · 858 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Topwin Speedy EnemaGLYCERINHealth Chemical Pharmaceutical Co., Ltd3ba8c3d2-1780-42e1-bec5-8f98771d475e2026-07-27WarningsExact identifier
application number: M007
Curewell Senna SyrupSENNOSIDESRMT HEALTH LLC57345324-5140-5cde-e063-6294a90ab97c2026-07-22WarningsExact identifier
application number: M007
Magnesium CitrateMAGNESIUM CITRATE ORAL SOLUTIONWALGREEN COMPANY4ffe54ae-3126-ba58-e063-6294a90a88772026-07-20WarningsExact identifier
application number: M007
Stool Softener LaxativeDOCUSATE SODIUMBryant Ranch Prepackdeca083b-5c72-40fa-9021-b74028426a5a2026-07-20WarningsExact identifier
application number: M007
Docusate SodiumDOCUSATE SODIUMCardinal Health 107, LLCfc5e82b6-e25c-4686-9781-2205819685f52026-07-20WarningsExact identifier
application number: M007
Best Choice Fiber Therapy Orange FlavorPSYLLIUM HUSKBEST CHOICE (VALU MERCHANDISERS COMPANY)0b25f6c0-441b-41ef-ab19-2a29705a56c62026-07-17WarningsExact identifier
application number: M007
Best Choice Fiber Therapy original coarsePSYLLIUM HUSKBEST CHOICE (VALU MERCHANDISERS COMPANY)d7eb71af-17e3-465e-b464-f77b3be7266d2026-07-17WarningsExact identifier
application number: M007
Best ChoiceCALCIUM POLYCARBOPHILBEST CHOICE (VALU MERCHANDISERS COMPANY)24eb538f-abcb-4a91-b691-a8aac01c952a2026-07-17WarningsExact identifier
application number: M007
Best Choice Fiber LaxativePSYLLIUM HUSKBEST CHOICE (VALU MERCHANDISERS COMPANY)92b46689-b5fc-41f4-91ac-535699900b392026-07-17WarningsExact identifier
application number: M007
citromaMAGNESIUM CITRATECVS Pharmacy, Inc.498acb19-b2f4-4af0-8996-390115c17fe02026-07-17Warnings, Adverse reactionsExact identifier
application number: M007
Best Choice Fiber TherapyMETHYLCELLULOSEBEST CHOICE (VALU MERCHANDISERS COMPANY)fab6567f-d988-43f2-a6cf-44e5b24af2792026-07-17WarningsExact identifier
application number: M007
stool softenerDOCUSATE SODIUMAmazon.com Services LLC4f83953e-3779-43b7-a5c6-7442a0675d9b2026-07-16WarningsExact identifier
application number: M007
Stool Softener Extra StrengthDOCUSATE SODIUMDolgencorp, Inc. (DOLLAR GENERAL & REXALL)183576bd-c252-471b-8797-32cac5b0329c2026-07-16WarningsExact identifier
application number: M007
Stool SoftenerDOCUSATE SODIUMWalgreens3f9d54d9-a9d5-40ff-a8a2-431997b589992026-07-16WarningsExact identifier
application number: M007
Stool Softener LaxativeDOCUSATE SODIUMWalgreens7174021b-bdc0-4fd3-90e7-3904980033c42026-07-16WarningsExact identifier
application number: M007
Stool SoftenerDOCUSATE SODIUMSTRATEGIC SOURCING SERVICES LLCff2179bd-cc76-9ee9-e053-6294a90a01c92026-07-15WarningsExact identifier
application number: M007
FEVIA Constipation ControlDOCUSATE SODIUMVIVUNT PHARMA LLC4b21ca11-b81f-402c-e063-6394a90a3acb2026-07-15WarningsExact identifier
application number: M007
Stool SoftenerDOCUSATE SODIUMSTRATEGIC SOURCING SERVICES LLC56957a51-7366-f7ed-e063-6294a90abfc52026-07-14WarningsExact identifier
application number: M007
LaxativeSENNOSIDESDolgencorp, Inc. (DOLLAR GENERAL & REXALL)6103fded-622c-4551-9f32-ca1da44683ac2026-07-10WarningsExact identifier
application number: M007
Stool Softener LaxativeDOCUSATE SODIUMThe Kroger Co.800fa966-077d-4624-9e36-75fe8863dad02026-07-10WarningsExact identifier
application number: M007

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1247756Colace 100 MG Oral CapsulePSNa6ffb144-0679-4702-8d97-7a78e176911e1
1115005docusate sodium 100 MG Oral CapsulePSNa6ffb144-0679-4702-8d97-7a78e176911e1
1247756docusate sodium 100 MG Oral Capsule [Colace]SBDa6ffb144-0679-4702-8d97-7a78e176911e1
1115005docusate sodium 100 MG Oral CapsuleSCDa6ffb144-0679-4702-8d97-7a78e176911e1
1247756Colace 100 MG Oral CapsuleSYa6ffb144-0679-4702-8d97-7a78e176911e1
1115005DOSS Sodium 100 MG Oral CapsuleSYa6ffb144-0679-4702-8d97-7a78e176911e1
1247756DOSS Sodium 100 MG Oral Capsule [Colace]SYa6ffb144-0679-4702-8d97-7a78e176911e1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67618-101-01676180101011 BOTTLE, PLASTIC in 1 CARTON (67618-101-01) / 100 CAPSULE in 1 BOTTLE, PLASTIC2022-01-170000-00-00NoNoCurrent
67618-101-10676180101102 BLISTER PACK in 1 CARTON (67618-101-10) / 5 CAPSULE in 1 BLISTER PACK2 blister pack1997-01-300000-00-00NoNoCurrent
67618-101-2567618010125250 CAPSULE in 1 BOTTLE, PLASTIC (67618-101-25) 250 capsule2026-05-27NoNoCurrent
67618-101-30676180101301 BOTTLE, PLASTIC in 1 CARTON (67618-101-30) / 30 CAPSULE in 1 BOTTLE, PLASTIC1997-01-300000-00-00NoNoCurrent
67618-101-5167618010151150 CAPSULE in 1 BOTTLE, PLASTIC (67618-101-51) 150 capsule2025-02-28NoNoCurrent
67618-101-5267618010152250 CAPSULE in 1 BOTTLE, PLASTIC (67618-101-52) 250 capsule1997-01-302028-09-30NoNoCurrent
67618-101-60676180101601 BOTTLE, PLASTIC in 1 CARTON (67618-101-60) / 60 CAPSULE in 1 BOTTLE, PLASTIC1997-01-300000-00-00NoNoCurrent