Stool Softener Laxative

Product NDC
72476-853
11-digit product format
724760853
Labeler code
72476
Product ID
72476-853_0cf68456-fdad-4cf7-af8f-f50203c4cecf
Type
HUMAN OTC DRUG
Nonproprietary name
DOCUSATE SODIUM
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
Care One (Retail Business Services, LLC.)
Application
M007
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-03-26
Substance
DOCUSATE SODIUM
Active strength
100 mg/1
NDC exclude flag
No
Listing certified through
2027-12-31
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 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
16691fd4-cdf3-41d4-b851-5fa148a05468Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72476-853-10Stool Softener Laxative100 in 1 BOTTLE, PLASTICCAPSULE, LIQUID FILLED1003
72476-853-25Stool Softener Laxative250 in 1 BOTTLE, PLASTICCAPSULE, LIQUID FILLED2503

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72476-853STOOL SOFTENER LAXATIVE (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [CARE ONE (RETAIL BUSINESS SERVICES, LLC.)]3Current NDC, Legacy NDC, 2 package rows20240307_16691fd4-cdf3-41d4-b851-5fa148a05468.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 22 of 42 · 833 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Senna SyrupNATURAL VEGETABLE LAXATIVEMethod Pharmaceuticalsce83ba78-7e0d-b37f-e053-2995a90a93832025-10-21WarningsExact identifier
application number: M007
Fiber LaxCALCIUM POLYCARBOPHILPD-Rx Pharmaceuticals, Inc.730198a5-b6d9-4fc7-b053-a7c65a93c5402025-10-20WarningsExact identifier
application number: M007
GlycerinGLYCERINChain Drug Consortium LLC4694f05b-d927-4e15-9630-a0a1cddb3cbb2025-10-16WarningsExact identifier
application number: M007
GlycerinGLYCERINAmerisource Bergen/Good Neighbor Pharmacye6a8914f-cfd9-4c72-abaa-22189bf0faef2025-10-16WarningsExact identifier
application number: M007
GlycerinGLYCERINChain Drug Marketing Association Inc.3386fada-6b7f-46fd-e063-6294a90abffc2025-10-16WarningsExact identifier
application number: M007
Senna SyrupSENNA SYRUPKesin Pharma Corporation360fb98d-c6ad-7bcc-e063-6294a90a94532025-10-14WarningsExact identifier
application number: M007
GlycerinGLYCERINH E B3d0566a1-57a5-6a31-e054-00144ff88e882025-10-09WarningsExact identifier
application number: M007
SENNA WITH DOCUSATE SODIUMDOCUSATE SODIUM AND SENNOSIDESHHH Pharmaceuticals2bbb1b99-d43c-40a3-bc53-e18e8394c3182025-10-08WarningsExact identifier
application number: M007
Castor OilCASTOR OILBIONPHARMA INC.3f9728e8-c7a2-6cfb-e063-6394a90a8f1d2025-10-06WarningsExact identifier
application number: M007
SennosidesSENNOSIDESInvaTech Pharma Solutions LLC3de39fbd-29be-fce7-e063-6394a90a67ae2025-10-03WarningsExact identifier
application number: M007
Metamucil Therapy for regularityPSYLLIUM HUSKThe Procter & Gamble Manufacturing Companya9824f73-5ea2-4a65-a926-3a57561441b82025-10-01WarningsExact identifier
application number: M007
OneLAX SENNASENNAAtlantic Biologicals Corp.40202c76-4273-88fd-e063-6394a90a07b22025-10-01WarningsExact identifier
application number: M007
Magnesium CitrateMAGNESIUM CITRATE ORAL SOLUTIONBionpharma, Inc.4019fbd0-fcf9-77a6-e063-6294a90a5ae72025-09-30WarningsExact identifier
application number: M007
LEADER HYDROCORTISONE WITH ALOEHYDROCORTISONELEADER39916470-15bf-4bd0-96e2-b909d68cf9c42025-09-29WarningsExact identifier
application number: M007
Leader Ready to Use Mineral Oil LaxativeMINERAL OILCardinal Healthb8494d02-8a7d-47b4-80b0-b8ab51b625fd2025-09-29WarningsExact identifier
application number: M007
Leader Ready to Use Saline LaxativeSODIUM PHOSPHATE, DIBASIC AND SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORMCardinal Health1b4f9c28-0547-4922-aa15-990c6fd9dc9f2025-09-29WarningsExact identifier
application number: M007
Milk of MagnesiaMAGNESIUM HYDROXIDEKesin Pharma Corporation3f7cff50-749b-5275-e063-6394a90af4072025-09-23WarningsExact identifier
application number: M007
Stimulant Laxative Plus Stool SoftenerDOCUSATE SODIUM 50 MG AND SENNOSIDES 8.6 MGBryant Ranch Prepack12f613e4-c919-4cc4-a445-eb30039ae45f2025-09-18WarningsExact identifier
application number: M007
Saline LaxativeSALINE LAXATIVEMajor Pharmaceuticalsb3758ffe-1bac-4df6-9714-5e33e9d28d902025-09-16WarningsExact identifier
application number: M007
Gentle LaxativeBISACODYLBETTER LIVING BRANDS LLC.f29d57f6-0938-d459-e053-2995a90ad86b2025-09-13WarningsExact identifier
application number: M007

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1115005docusate sodium 100 MG Oral CapsulePSN16691fd4-cdf3-41d4-b851-5fa148a054683
1115005docusate sodium 100 MG Oral CapsuleSCD16691fd4-cdf3-41d4-b851-5fa148a054683
1115005DOSS Sodium 100 MG Oral CapsuleSY16691fd4-cdf3-41d4-b851-5fa148a054683

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
72476-853-1072476085310100 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (72476-853-10) 2021-03-260000-00-00NoNoCurrent
72476-853-2572476085325250 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (72476-853-25) 2021-03-260000-00-00NoNoCurrent