Stool Softener Laxative

Product NDC
68788-8501
11-digit product format
687888501
Labeler code
68788
Product ID
68788-8501_60359b6b-60a9-499e-a060-b8a4a5b874a3
Type
HUMAN OTC DRUG
Nonproprietary name
DOCUSATE SODIUM
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
334
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-08-09
Substance
DOCUSATE SODIUM
Active strength
100 mg/1
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Stool Softener Laxative
Listing expiration
2027-12-31

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
68788-8501-1Stool Softener Laxative100 in 1 BOTTLE, PLASTICCAPSULE, LIQUID FILLED1004
68788-8501-3Stool Softener Laxative30 in 1 BOTTLE, PLASTICCAPSULE, LIQUID FILLED304
68788-8501-6Stool Softener Laxative60 in 1 BOTTLE, PLASTICCAPSULE, LIQUID FILLED604

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-8501STOOL SOFTENER LAXATIVE (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [PREFERRED PHARMACEUTICALS INC.]3Current NDC, 3 package rows20250403_867a7771-6846-427d-b526-b964d74f7700.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1115005docusate sodium 100 MG Oral CapsulePSN867a7771-6846-427d-b526-b964d74f77004
1115005docusate sodium 100 MG Oral CapsuleSCD867a7771-6846-427d-b526-b964d74f77004
1115005DOSS Sodium 100 MG Oral CapsuleSY867a7771-6846-427d-b526-b964d74f77004

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
68788-8501-168788850101100 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (68788-8501-1) 2023-08-09NoNoHistorical
68788-8501-36878885010330 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (68788-8501-3) 2023-08-09NoNoHistorical
68788-8501-66878885010660 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (68788-8501-6) 2023-08-09NoNoHistorical