Stool Softener

Product NDC
68196-853
11-digit product format
681960853
Labeler code
68196
Product ID
68196-853_d737c0ad-f89f-4b67-94cd-6837dd086ab0
Type
HUMAN OTC DRUG
Nonproprietary name
DOCUSATE SODIUM
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
Sam's West, Inc
Application
M007
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-05-28
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
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68196-853-602023-05-09C16284748780-1f386c64a-1c5f-0266-e053-dadaa90a7c1aDrug Facts
68196-853-602023-01-30C16284748780-1f386c64a-1c5f-0266-e053-dadaa90a7c1aDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68196-853-60Stool Softener600 in 1 BOTTLE, PLASTICCAPSULE, LIQUID FILLED6003

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68196-853STOOL SOFTENER (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [SAM'S WEST, INC]3Current NDC, Legacy NDC, 1 package rows20240522_b14d2495-1092-4063-869f-73a7e8c28708.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1115005docusate sodium 100 MG Oral CapsulePSNb14d2495-1092-4063-869f-73a7e8c287083
1115005docusate sodium 100 MG Oral CapsuleSCDb14d2495-1092-4063-869f-73a7e8c287083
1115005DOSS Sodium 100 MG Oral CapsuleSYb14d2495-1092-4063-869f-73a7e8c287083

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68196-853-6068196085360600 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (68196-853-60) 2021-05-280000-00-00NoNoCurrent