Stool Softener Laxative

Product NDC
36800-568
11-digit product format
368000568
Labeler code
36800
Product ID
36800-568_e80d6e87-9467-4014-98c1-05e85559c86f
Type
HUMAN OTC DRUG
Nonproprietary name
Docusate Sodium
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
TOP CARE (Topco Associates LLC)
Application
M007
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2019-11-29
Marketing end
2026-08-29
Substance
DOCUSATE SODIUM
Active strength
250 mg/1
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Stool Softener Laxative
Brand name suffix
Extra Strength

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DOCUSATE SODIUM250 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiF05Q2T2JA0
Rxcui1245468

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
36800-568-10Stool Softener LaxativeExtra Strength100 in 1 BOTTLE, PLASTICCAPSULE, LIQUID FILLED1003

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
36800-568STOOL SOFTENER LAXATIVE EXTRA STRENGTH (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [TOP CARE (TOPCO ASSOCIATES LLC)]3Current NDC, Legacy NDC, 1 package rows20241115_3f81e49a-9a0c-48fd-a2a3-9e665493bace.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1245468docusate sodium 250 MG Oral CapsulePSN3f81e49a-9a0c-48fd-a2a3-9e665493bace3
1245468docusate sodium 250 MG Oral CapsuleSCD3f81e49a-9a0c-48fd-a2a3-9e665493bace3
1245468DOSS Sodium 250 MG Oral CapsuleSY3f81e49a-9a0c-48fd-a2a3-9e665493bace3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
36800-568-1036800056810100 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (36800-568-10) 2019-11-292026-08-29NoNoCurrent