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 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
d616685a-11fc-4ae0-80de-7d25c0d71ee9Available on FDA.report

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

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 44 · 872 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MiraFAST KIDS soft chewsMAGNESIUM HYDROXIDEBayer HealthCare LLC.58636827-239d-cc63-e063-6294a90a61802026-08-06WarningsExact identifier
application number: M007
Stool Softener Extra StrengthDOCUSATE SODIUMP & L Development, LLC4e97dd60-96e3-4b51-b614-c62480af19192026-08-06WarningsExact identifier
application number: M007
Stool Softener LaxativeDOCUSATE SODIUMP & L Development, LLC098d2377-0019-45fe-b995-700b1b1241c42026-08-05WarningsExact identifier
application number: M007
Docusate Sodium softgels 50mg (Dye Free)DOCUSATE SODIUMCVS Pharmacy273ea95f-3c9c-98e8-e063-6294a90a21352026-08-05WarningsExact identifier
application number: M007
Mineral OilMINERAL OILOld East Main Co.4bae831d-caba-40c9-bdb5-2611eac35dd52026-08-05Warnings, Adverse reactionsExact identifier
application number: M007
MiraFAST soft chewsMAGNESIUM HYDROXIDEBayer HealthCare LLC.2cee67dd-b71f-32b8-e063-6394a90ae8642026-08-05WarningsExact identifier
application number: M007
MiraSOFT Stool SoftenerDOCUSATE SODIUMBayer HealthCare LLC.5851f15f-8add-559f-e063-6394a90a7b7d2026-08-05WarningsExact identifier
application number: M007
Stool Softener LaxativeDOCUSATE SODIUMP & L Development, LLCcbb0edf4-1fa7-42f5-a6f7-027e3961b50a2026-08-05WarningsExact identifier
application number: M007
Metamucil Therapy for regularityPSYLLIUM HUSKAtlantic Biologicals Corp.57b112ea-f6b1-baa6-e063-6394a90a3b292026-08-04WarningsExact identifier
application number: M007
SennosidesSENNOSIDESLEADER/ Cardinal Health 110, Inc.e3c7ece8-82f3-cd0c-e053-2995a90ad8002026-08-04WarningsExact identifier
application number: M007
ColaceDOCUSATE SODIUMAtlantis Consumer Healthcare, Inc.7793fced-e8ee-44e2-b212-dd2a59a5f4622026-08-04WarningsExact identifier
application number: M007
Dual Action Senna Stool SoftenerDOCUSATE SODIUM 50 MG, SENNOSIDES 8.6 MGShield Pharmaceuticals Corpa04435df-aace-497f-a3a8-d8e8489db6612026-08-03WarningsExact identifier
application number: M007
Docusate Sodium - Stool Softener LaxativeDOCUSATE SODIUMCardinal Health 107, LLCb5e4b14d-bf11-4309-bf6d-65ee9d877a242026-07-28WarningsExact identifier
application number: M007
Topwin Speedy EnemaGLYCERINHealth Chemical Pharmaceutical Co., Ltd3ba8c3d2-1780-42e1-bec5-8f98771d475e2026-07-27WarningsExact identifier
application number: M007
Curewell Senna SyrupSENNOSIDESRMT HEALTH LLC57345324-5140-5cde-e063-6294a90ab97c2026-07-22WarningsExact identifier
application number: M007
Magnesium CitrateMAGNESIUM CITRATE ORAL SOLUTIONWALGREEN COMPANY4ffe54ae-3126-ba58-e063-6294a90a88772026-07-20WarningsExact identifier
application number: M007
Stool Softener LaxativeDOCUSATE SODIUMBryant Ranch Prepackdeca083b-5c72-40fa-9021-b74028426a5a2026-07-20WarningsExact identifier
application number: M007
Docusate SodiumDOCUSATE SODIUMCardinal Health 107, LLCfc5e82b6-e25c-4686-9781-2205819685f52026-07-20WarningsExact identifier
application number: M007
Best Choice Fiber Therapy Orange FlavorPSYLLIUM HUSKBEST CHOICE (VALU MERCHANDISERS COMPANY)0b25f6c0-441b-41ef-ab19-2a29705a56c62026-07-17WarningsExact identifier
application number: M007
Best Choice Fiber Therapy original coarsePSYLLIUM HUSKBEST CHOICE (VALU MERCHANDISERS COMPANY)d7eb71af-17e3-465e-b464-f77b3be7266d2026-07-17WarningsExact identifier
application number: M007

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) 2026-01-07NoNoCurrent
71335-9731-17133597310130 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (71335-9731-1) 2023-07-18NoNoCurrent
71335-9731-271335973102100 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (71335-9731-2) 2023-10-09NoNoCurrent
71335-9731-37133597310360 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (71335-9731-3) 2023-07-17NoNoCurrent
71335-9731-471335973104120 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (71335-9731-4) 2026-04-09NoNoCurrent
71335-9731-57133597310590 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (71335-9731-5) 2023-10-17NoNoCurrent
71335-9731-671335973106180 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (71335-9731-6) 2026-04-09NoNoCurrent
71335-9731-77133597310710 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (71335-9731-7) 2026-04-09NoNoCurrent
71335-9731-87133597310828 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (71335-9731-8) 2025-05-15NoNoCurrent
71335-9731-97133597310956 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (71335-9731-9) 2024-12-26NoNoCurrent