FDA.reportPublic FDA data

Stool Softener Laxative

Product NDC
71335-9731
11-digit product format
713359731
Labeler code
71335
Product ID
71335-9731_2f8a60f0-1546-455f-9083-ad4935b0ca01
Type
HUMAN OTC DRUG
Nonproprietary name
DOCUSATE SODIUM
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
M007
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-11-15
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
71335-9731-0Stool Softener Laxative18 in 1 BOTTLE, PLASTICCAPSULE, LIQUID FILLED18104
71335-9731-1Stool Softener Laxative30 in 1 BOTTLE, PLASTICCAPSULE, LIQUID FILLED30104
71335-9731-2Stool Softener Laxative100 in 1 BOTTLE, PLASTICCAPSULE, LIQUID FILLED100104
71335-9731-3Stool Softener Laxative60 in 1 BOTTLE, PLASTICCAPSULE, LIQUID FILLED60104
71335-9731-4Stool Softener Laxative120 in 1 BOTTLE, PLASTICCAPSULE, LIQUID FILLED120104
71335-9731-5Stool Softener Laxative90 in 1 BOTTLE, PLASTICCAPSULE, LIQUID FILLED90104
71335-9731-6Stool Softener Laxative180 in 1 BOTTLE, PLASTICCAPSULE, LIQUID FILLED180104
71335-9731-7Stool Softener Laxative10 in 1 BOTTLE, PLASTICCAPSULE, LIQUID FILLED10104
71335-9731-8Stool Softener Laxative28 in 1 BOTTLE, PLASTICCAPSULE, LIQUID FILLED28104
71335-9731-9Stool Softener Laxative56 in 1 BOTTLE, PLASTICCAPSULE, LIQUID FILLED56104

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-9731STOOL SOFTENER LAXATIVE (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [BRYANT RANCH PREPACK]103Current NDC, 10 package rows20240919_d616685a-11fc-4ae0-80de-7d25c0d71ee9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1115005docusate sodium 100 MG Oral CapsulePSNd616685a-11fc-4ae0-80de-7d25c0d71ee9104
1115005docusate sodium 100 MG Oral CapsuleSCDd616685a-11fc-4ae0-80de-7d25c0d71ee9104
1115005DOSS Sodium 100 MG Oral CapsuleSYd616685a-11fc-4ae0-80de-7d25c0d71ee9104

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
71335-9731-07133597310018 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (71335-9731-0) 2026-01-07NoNoHistorical
71335-9731-17133597310130 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (71335-9731-1) 2023-07-18NoNoHistorical
71335-9731-271335973102100 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (71335-9731-2) 2023-10-09NoNoHistorical
71335-9731-37133597310360 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (71335-9731-3) 2023-07-17NoNoHistorical
71335-9731-471335973104120 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (71335-9731-4) 2026-04-09NoNoHistorical
71335-9731-57133597310590 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (71335-9731-5) 2023-10-17NoNoHistorical
71335-9731-671335973106180 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (71335-9731-6) 2026-04-09NoNoHistorical
71335-9731-77133597310710 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (71335-9731-7) 2026-04-09NoNoHistorical
71335-9731-87133597310828 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (71335-9731-8) 2025-05-15NoNoHistorical
71335-9731-97133597310956 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (71335-9731-9) 2024-12-26NoNoHistorical