FDA.reportPublic FDA data

Dulcolax Stool Softener

Product NDC
41167-0221
11-digit product format
411670221
Labeler code
41167
Product ID
41167-0221_30425636-e884-4991-b31b-1d56948a6953
Type
HUMAN OTC DRUG
Nonproprietary name
Docusate sodium
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
Chattem, Inc.
Application
M007
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-08-01
Substance
DOCUSATE SODIUM
Active strength
100 mg/1
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage41167-022141167-0221-9DDiscontinued by firm2026-10-20

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 10 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…

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
Dulcolax Stool Softener
Listing expiration
2026-12-31

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 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1115005Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
86cb7102-3585-4757-9c37-5bf9776bbe63Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
41167-0221-2Dulcolax Stool Softener1 in 1 CARTONCAPSULE, LIQUID FILLED17
41167-0221-2Dulcolax Stool Softener25 in 1 BOTTLECAPSULE, LIQUID FILLED257
41167-0221-3Dulcolax Stool Softener1 in 1 CARTONCAPSULE, LIQUID FILLED17
41167-0221-3Dulcolax Stool Softener50 in 1 BOTTLECAPSULE, LIQUID FILLED507
41167-0221-4Dulcolax Stool Softener1 in 1 CARTONCAPSULE, LIQUID FILLED17
41167-0221-4Dulcolax Stool Softener100 in 1 BOTTLECAPSULE, LIQUID FILLED1007
41167-0221-9Dulcolax Stool Softener30 in 1 BOTTLECAPSULE, LIQUID FILLED307
41167-0221-9Dulcolax Stool Softener1 in 1 CARTONCAPSULE, LIQUID FILLED17

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41167-0221DULCOLAX STOOL SOFTENER (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [CHATTEM, INC.]6Current NDC, Legacy NDC, 8 package rows20250308_86cb7102-3585-4757-9c37-5bf9776bbe63.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 11 of 42 · 833 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Mineral OilMINERAL OILUnited Natural Foods, Inc. dba UNFIcb7bc571-295f-47c2-ae93-18cba194752c2026-02-17Warnings, Adverse reactionsExact identifier
application number: M007
Mineral OilMINERAL OILStrategic Sourcing Services LLCe4965086-dcc0-4b34-bb30-81facf7139f32026-02-17Warnings, Adverse reactionsExact identifier
application number: M007
Magnesium CitrateMAGNESIUM CITRATEValu Merchandisers Companycd3e5836-b2f0-41f3-8623-3105c46424912026-02-16Warnings, Adverse reactionsExact identifier
application number: M007
citromaMAGESIUM CITRATEValu Merchandisers Companya693f6b0-0679-4609-9ca0-dddfa4158c022026-02-16Warnings, Adverse reactionsExact identifier
application number: M007
citromaMAGNESIUM CITRATEValu Merchandisers Companyfb358bc3-e479-42e7-8aea-a6a3676f24302026-02-16Warnings, Adverse reactionsExact identifier
application number: M007
Epsom SaltMAGNESIUM SULFATEValu Merchandisers Companyff539c1c-9ed3-49be-9b30-1858f12e1e902026-02-16Warnings, Adverse reactionsExact identifier
application number: M007
Castor OilCASTOR OILUnited Natural Foods, Inc. dba UNFIbd19bea3-5ac9-4f8d-b1a0-478fd9c8a01f2026-02-16Warnings, Adverse reactionsExact identifier
application number: M007
Walgreens SmoothLAX Soft ChewsMAGNESIUM HYDROXIDEWalgreens424e27ce-0b11-9cd2-e063-6294a90a3c212026-02-16WarningsExact identifier
application number: M007
citromaMAGNESIUM CITRATEUnited Natural Foods, Inc. dba UNFIda013c15-3531-4dc5-b122-bfc99bc494ae2026-02-16Warnings, Adverse reactionsExact identifier
application number: M007
citromaMAGNESIUM CITRATEUnited Natural Foods, Inc. dba UNFIdb1bc651-1a35-4f92-a917-c6a19f4215942026-02-16Warnings, Adverse reactionsExact identifier
application number: M007
Stool Softener LaxativeDOCUSATE SODIUMThe Kroger Co.e1a68bd9-d31a-46a6-8c08-7ad8197b6e0b2026-02-13WarningsExact identifier
application number: M007
Epsom SaltMAGNESIUM SULFATETopco Associates LLCb2ec06b3-647d-49ab-a392-6db63d96d1e32026-02-13Warnings, Adverse reactionsExact identifier
application number: M007
Castor OilCASTOR OILTopco Associates LLC5643f2e0-93e2-4c2e-90a0-fd152150d18a2026-02-13Warnings, Adverse reactionsExact identifier
application number: M007
citromaMAGESIUM CITRATETopco Associates LLCd3cc7cb6-098e-413c-b1ad-7ebf5fa352692026-02-13Warnings, Adverse reactionsExact identifier
application number: M007
citromaMAGNESIUM CITRATETopco Associates LLCbc89c4bc-5207-479d-9a3b-e570b412a7ba2026-02-13Warnings, Adverse reactionsExact identifier
application number: M007
Epsom SaltMAGNESIUM SULFATETopco Associates LLC72f69aa0-381a-4e5c-975d-3a73fdc1b3772026-02-13Warnings, Adverse reactionsExact identifier
application number: M007
Mineral OilMINERAL OILTopco Associates LLCe9b1fd61-c229-4529-82c2-d6ac5b0760822026-02-13WarningsExact identifier
application number: M007
Magnesium CitrateMAGNESIUM CITRATEPinnacle RX LLC4abbb0e4-e005-bc4e-e063-6394a90a126a2026-02-13Warnings, Adverse reactionsExact identifier
application number: M007
365 Whole Foods Market Epsom SaltMAGNESIUM SULFATEWhole Foods Market, Inc.4147cdd0-57f6-3857-e063-6394a90afecb2026-02-12Warnings, Adverse reactionsExact identifier
application number: M007
Epsom SaltMAGNESIUM SULFATEYour Military Exchanges27cff497-123c-424a-9c43-57740c00168b2026-02-12Warnings, Adverse reactionsExact identifier
application number: M007

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1115005docusate sodium 100 MG Oral CapsulePSN86cb7102-3585-4757-9c37-5bf9776bbe637
1115005docusate sodium 100 MG Oral CapsuleSCD86cb7102-3585-4757-9c37-5bf9776bbe637
1115005DOSS Sodium 100 MG Oral CapsuleSY86cb7102-3585-4757-9c37-5bf9776bbe637

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
41167-0221-2411670221021 BOTTLE in 1 CARTON (41167-0221-2) / 25 CAPSULE, LIQUID FILLED in 1 BOTTLE1 bottle2020-08-010000-00-00NoNoCurrent
41167-0221-3411670221031 BOTTLE in 1 CARTON (41167-0221-3) / 50 CAPSULE, LIQUID FILLED in 1 BOTTLE1 bottle2020-08-010000-00-00NoNoCurrent
41167-0221-4411670221041 BOTTLE in 1 CARTON (41167-0221-4) / 100 CAPSULE, LIQUID FILLED in 1 BOTTLE1 bottle2020-08-010000-00-00NoNoCurrent
41167-0221-9411670221091 BOTTLE in 1 CARTON (41167-0221-9) > 30 CAPSULE, LIQUID FILLED in 1 BOTTLE1 bottle2020-08-010000-00-00NoNoCurrent