Stool Softener Laxative

Product NDC
68391-853
11-digit product format
683910853
Labeler code
68391
Product ID
68391-853_84cdf017-be92-4126-93f8-64e3dfec62b2
Type
HUMAN OTC DRUG
Nonproprietary name
DOCUSATE SODIUM
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
BJWC (Berkley & Jensen / BJ's)
Application
M007
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-01-29
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 Laxative
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
68391-853-40Stool Softener Laxative400 in 1 BOTTLE, PLASTICCAPSULE, LIQUID FILLED4003

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68391-853STOOL SOFTENER LAXATIVE (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [BJWC (BERKLEY & JENSEN / BJ'S)]3Current NDC, Legacy NDC, 1 package rows20240224_4ce62421-97e0-4920-9a6d-9fa1f0f93fe4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1115005docusate sodium 100 MG Oral CapsulePSN4ce62421-97e0-4920-9a6d-9fa1f0f93fe43
1115005docusate sodium 100 MG Oral CapsuleSCD4ce62421-97e0-4920-9a6d-9fa1f0f93fe43
1115005DOSS Sodium 100 MG Oral CapsuleSY4ce62421-97e0-4920-9a6d-9fa1f0f93fe43

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68391-853-4068391085340400 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (68391-853-40) 2021-01-290000-00-00NoNoCurrent