FDA.reportPublic FDA data

Stool Softener Laxative

Product NDC
79481-0853
11-digit product format
794810853
Labeler code
79481
Product ID
79481-0853_17d2a29c-b39d-432a-bdea-bced384b6fbf
Type
HUMAN OTC DRUG
Nonproprietary name
DOCUSATE SODIUM
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
Meijer Distribution Inc.
Application
M007
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-04-30
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
81edf0d8-b6f3-4b3a-85db-0108160756b1Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
79481-0853-1Stool Softener Laxative100 in 1 BOTTLE, PLASTICCAPSULE, LIQUID FILLED1005
79481-0853-2Stool Softener Laxative250 in 1 BOTTLE, PLASTICCAPSULE, LIQUID FILLED2505
79481-0853-4Stool Softener Laxative400 in 1 BOTTLE, PLASTICCAPSULE, LIQUID FILLED4005

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
79481-0853STOOL SOFTENER LAXATIVE (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [MEIJER DISTRIBUTION INC.]4Current NDC, Legacy NDC, 3 package rows20240413_81edf0d8-b6f3-4b3a-85db-0108160756b1.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 34 of 42 · 833 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Senna-SSENNOSIDES 8.6MG AND DOCUSATE SODIUM 50MGProficient Rx LP8678a3ee-0e2c-4c95-ad2e-83aa601f32382024-10-01WarningsExact identifier
application number: M007
Pedia-LaxDOCUSATE SODIUMC.B. Fleet Company, Inc.0e908bea-ebab-44e7-919c-90002e6f5d422024-10-01WarningsExact identifier
application number: M007
Natural Vegetable Laxative and Stool SoftenerDOCUSATE SODIUM AND SENNOSIDESBETTER LIVING BRANDS LLC.f2c562e1-4080-44cb-e053-2a95a90a42222024-09-25WarningsExact identifier
application number: M007
SENNA-S LAXATIVE WITH STOOL SOFTENERSENNOSIDESBasic Drugs, Inc.d32b9956-fc04-8d64-e053-2a95a90a17b32024-09-14WarningsExact identifier
application number: M007
DOCUSATE SODIUM, EXTRA STRENGTH 250 MGDOCUSATE SODIUMAdvanced Rx LLCe8be12c5-c591-eadd-e053-2a95a90a431b2024-09-13WarningsExact identifier
application number: M007
SennaSENNOSIDESProficient Rx LP5f7f0df4-dabe-4c8f-a2b5-766f20af2f462024-09-01WarningsExact identifier
application number: M007
Fiber caplets 147CALCIUM POLYCARBOPHILChain Drug Marketing Association Inc.17e2a50d-1867-49fe-e063-6394a90a56df2024-08-27WarningsExact identifier
application number: M007
MAXIMUM STRENGTH LAXATIVE PILLSSENNOSIDESTARGET CORPORATION7cae52ae-931c-3e7c-e053-2991aa0a83962024-08-22WarningsExact identifier
application number: M007
STOOL SOFTENER AND STIMULANT LAXATIVEDOCUSATE SODIUM AND SENNOSIDESTARGET CORPORATION7cac99da-8d89-0aee-e053-2991aa0a0fd92024-08-22WarningsExact identifier
application number: M007
SENNA LAXATIVESENNOSIDES 8.6 MGTARGET CORPORATION7cab058f-3647-7124-e053-2a91aa0a41bd2024-08-22WarningsExact identifier
application number: M007
Docusate SodiumDOCUSATE SODIUMPadagis Israel Pharmaceuticals Ltdbce3b245-ec47-4e62-9cad-bb12d0812c182024-08-15WarningsExact identifier
application number: M007
Docusate SodiumDOCUSATE SODIUMNuCare Pharmaceuticals,Inc.56f7966a-c95e-3ce3-e054-00144ff88e882024-08-14WarningsExact identifier
application number: M007
Stool Softener LaxativeDOCUSATE SODIUMProficient Rx LPccfa095c-77f0-41ff-84f8-e02d983c7c742024-08-01WarningsExact identifier
application number: M007
Magnesium CitrateHARRIS TEETER MAGNESIUM CITRATE ORAL SOLUTION - LEMONHarris Teeter, LLC1e8e01fc-2c89-9722-e063-6394a90a6acf2024-07-31WarningsExact identifier
application number: M007
Senna laxativeSENNOSIDESBest Choice (Valu Merchandisers Company)d5f90aa1-78e5-491f-b09d-399d54f3def12024-07-31WarningsExact identifier
application number: M007
Stool Softener Laxative Plus StimulantDOCUSATE SODIUM AND SENNOSIDESWalgreensdb528659-768a-46e0-a340-9fbcdb25ea5e2024-07-25WarningsExact identifier
application number: M007
Senna laxativeSENNOSIDESWalgreensbfa089a6-4767-45e0-b663-ee7e8949d9a42024-07-25WarningsExact identifier
application number: M007
Dr. FibraPSYLLIUM HUSKPharmadel LLC1a6151c9-e1c4-f0c1-e063-6394a90aad242024-07-22WarningsExact identifier
application number: M007
BISACODYLBISCODYLTARGET CORPORATION8ed281d5-b17e-e3bb-e053-2995a90a25902024-07-15WarningsExact identifier
application number: M007
Stool SoftenerDOCUSATE CALCIUMWalgreensb6f0770e-671d-4965-9275-b1c224d7f06a2024-07-10WarningsExact identifier
application number: M007

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1115005docusate sodium 100 MG Oral CapsulePSN81edf0d8-b6f3-4b3a-85db-0108160756b15
1115005docusate sodium 100 MG Oral CapsuleSCD81edf0d8-b6f3-4b3a-85db-0108160756b15
1115005DOSS Sodium 100 MG Oral CapsuleSY81edf0d8-b6f3-4b3a-85db-0108160756b15

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
79481-0853-179481085301100 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (79481-0853-1) 2021-04-300000-00-00NoNoCurrent
79481-0853-279481085302250 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (79481-0853-2) 2021-04-300000-00-00NoNoCurrent
79481-0853-479481085304400 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (79481-0853-4) 2021-04-300000-00-00NoNoCurrent