FDA.reportPublic FDA data

Stool Softener Laxative

Product NDC
68788-8501
Requested package NDC
68788-8501-1
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

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
Stool Softener Laxative
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 · 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
867a7771-6846-427d-b526-b964d74f7700Available on FDA.report

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

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 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Stool Softener LaxativeDOCUSATE SODIUMPreferred Pharmaceuticals Inc.867a7771-6846-427d-b526-b964d74f77002026-04-08WarningsExact identifier
ndc (package): 68788-8501-1
ndc (product): 68788-8501
ndc11 (package): 68788850101

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) 2023-08-09NoNoCurrent