FDA.reportPublic FDA data

Stool Softener

Product NDC
71335-0294
11-digit product format
713350294
Labeler code
71335
Product ID
71335-0294_982de9ab-1968-4284-9dd9-1d05bf048fde
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
2000-01-01
Substance
DOCUSATE SODIUM
Active strength
100 mg/1
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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 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
2c9a1fe7-b77b-436b-8701-9f95f642d001Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-0294-0Stool Softener50 in 1 BOTTLECAPSULE, LIQUID FILLED508
71335-0294-1Stool Softener30 in 1 BOTTLECAPSULE, LIQUID FILLED308
71335-0294-2Stool Softener100 in 1 BOTTLECAPSULE, LIQUID FILLED1008
71335-0294-3Stool Softener60 in 1 BOTTLECAPSULE, LIQUID FILLED608
71335-0294-4Stool Softener120 in 1 BOTTLECAPSULE, LIQUID FILLED1208
71335-0294-5Stool Softener90 in 1 BOTTLECAPSULE, LIQUID FILLED908
71335-0294-6Stool Softener180 in 1 BOTTLECAPSULE, LIQUID FILLED1808
71335-0294-7Stool Softener10 in 1 BOTTLECAPSULE, LIQUID FILLED108
71335-0294-8Stool Softener28 in 1 BOTTLECAPSULE, LIQUID FILLED288
71335-0294-9Stool Softener56 in 1 BOTTLECAPSULE, LIQUID FILLED568

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-0294-0EA - Each71335-02942a426e7c-5ba4-491b-a9f9-35da5ca1ef5012018-01-12
71335-0294-1EA - Each71335-02940814f62f-01a5-4830-bd48-a87f11ce9f2212018-01-12
71335-0294-2EA - Each71335-0294b3780648-4e65-4780-9b48-e7317c09a11412018-01-12
71335-0294-3EA - Each71335-02949b84ef75-60d3-4091-bf5b-729cb79396a212018-01-12
71335-0294-4EA - Each71335-0294b5c2d744-96ef-4712-90f6-2bb696766d7412018-01-12
71335-0294-5EA - Each71335-0294a00fd0e8-a544-491f-943b-7eef2511394c12018-01-12
71335-0294-6EA - Each71335-029489de2b53-630c-43d6-b5a0-a0d0e4defa7112018-01-12
71335-0294-7EA - Each71335-0294b40fa438-1b3e-4889-8e62-79e3b096278712018-01-12
71335-0294-8EA - Each71335-02943e62798c-1d9e-455f-b374-4b205309f38912018-01-12
71335-0294-9EA - Each71335-0294b24ea9eb-e2bf-4b8a-94db-f0bad33267ab12018-01-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-0294STOOL SOFTENER (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [BRYANT RANCH PREPACK]8Current NDC, Legacy NDC, 10 package rows20240707_2c9a1fe7-b77b-436b-8701-9f95f642d001.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 3 of 42 · 833 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Stool SoftenerDOCUSATE SODIUMDolgencorp, Inc. (DOLLAR GENERAL & REXALL)f4671579-aed0-4f93-ab83-248e0d72b5b02026-08-10WarningsExact identifier
application number: M007
Docusate Sodium LiquidDOCUSATE SODIUM.50MG/5MLAldama Pharmaceuticals, Inc492b6d37-47cf-3a28-e063-6294a90a2a182026-08-10WarningsExact identifier
application number: M007
Epsom SaltMAGNESIUM SULFATESafeway Inc0b757160-f9eb-4413-9b43-97544c49c72f2026-08-10Warnings, Adverse reactionsExact identifier
application number: M007
Bisacodyl LaxativeBISACODYLInvaDerm Corporation58ba9a9f-98d8-c380-e063-6294a90a774c2026-08-10WarningsExact identifier
application number: M007
SennosidesSENNOSIDESCardinal Health 107, LLC4a9e1cbe-ffe4-462f-a86d-078a357dcf492026-08-07WarningsExact identifier
application number: M007
Senna SDOCUSATE SODIUM, SENNOSIDESShield Pharmaceuticals Corp0be906d8-3db5-4218-bbdf-f1d1260079902026-08-07WarningsExact identifier
application number: M007
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
Metamucil Therapy for regularityPSYLLIUM HUSKAtlantic Biologicals Corp.57b112ea-f6b1-baa6-e063-6394a90a3b292026-08-05WarningsExact identifier
application number: M007
WinCo Pure 5lbPURE 5LB EPSOM SALTWinCo Foods, LLC58529382-a192-cda2-e063-6394a90adb692026-08-05WarningsExact identifier
application number: M007
Stool Softener LaxativeDOCUSATE SODIUMP & L Development, LLCcbb0edf4-1fa7-42f5-a6f7-027e3961b50a2026-08-05WarningsExact identifier
application number: M007
SennosidesSENNOSIDESLEADER/ Cardinal Health 110, Inc.e3c7ece8-82f3-cd0c-e053-2995a90ad8002026-08-04WarningsExact identifier
application number: M007
CVS GlycerinGLYCERIN SUPPOISITORYCVS Pharmacy, Incca6d13db-60e8-4fcc-b7b3-3eb280b8c4352026-08-04WarningsExact 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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1115005docusate sodium 100 MG Oral CapsulePSN2c9a1fe7-b77b-436b-8701-9f95f642d0018
1115005docusate sodium 100 MG Oral CapsuleSCD2c9a1fe7-b77b-436b-8701-9f95f642d0018
1115005DOSS Sodium 100 MG Oral CapsuleSY2c9a1fe7-b77b-436b-8701-9f95f642d0018

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-0294-07133502940050 CAPSULE, LIQUID FILLED in 1 BOTTLE (71335-0294-0) 2018-05-180000-00-00NoNoCurrent
71335-0294-17133502940130 CAPSULE, LIQUID FILLED in 1 BOTTLE (71335-0294-1) 2018-04-110000-00-00NoNoCurrent
71335-0294-271335029402100 CAPSULE, LIQUID FILLED in 1 BOTTLE (71335-0294-2) 2018-02-270000-00-00NoNoCurrent
71335-0294-37133502940360 CAPSULE, LIQUID FILLED in 1 BOTTLE (71335-0294-3) 2018-05-230000-00-00NoNoCurrent
71335-0294-471335029404120 CAPSULE, LIQUID FILLED in 1 BOTTLE (71335-0294-4) 2022-02-090000-00-00NoNoCurrent
71335-0294-57133502940590 CAPSULE, LIQUID FILLED in 1 BOTTLE (71335-0294-5) 2018-05-230000-00-00NoNoCurrent
71335-0294-671335029406180 CAPSULE, LIQUID FILLED in 1 BOTTLE (71335-0294-6) 2022-02-090000-00-00NoNoCurrent
71335-0294-77133502940710 CAPSULE, LIQUID FILLED in 1 BOTTLE (71335-0294-7) 2022-02-090000-00-00NoNoCurrent
71335-0294-87133502940828 CAPSULE, LIQUID FILLED in 1 BOTTLE (71335-0294-8) 2019-09-200000-00-00NoNoCurrent
71335-0294-97133502940956 CAPSULE, LIQUID FILLED in 1 BOTTLE (71335-0294-9) 2022-02-090000-00-00NoNoCurrent