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

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 Identifiers#

Field, Values table
FieldValues
UniiF05Q2T2JA0
Rxcui1115005

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

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