FDA.reportPublic FDA data

Stool Softener Laxative

Product NDC
59726-059
Requested package NDC
59726-059-10
11-digit product format
597260059
Labeler code
59726
Product ID
59726-059_383dd7bc-138d-4ecf-8090-1f559a3404a3
Type
HUMAN OTC DRUG
Nonproprietary name
Docusate Sodium
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
P & L Development, LLC
Application
M007
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-04-16
Substance
DOCUSATE SODIUM
Active strength
250 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
Brand name suffix
Extra Strength
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DOCUSATE SODIUM250 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
1245468Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
33000a06-e030-433a-8f9c-7ae5c08037faAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
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
59726-059-10Stool Softener LaxativeExtra Strength100 in 1 BOTTLECAPSULE, LIQUID FILLED1004

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59726-059STOOL SOFTENER LAXATIVE EXTRA STRENGTH (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [P & L DEVELOPMENT, LLC]3Current NDC, Legacy NDC, 1 package rows20240502_33000a06-e030-433a-8f9c-7ae5c08037fa.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 35 of 43 · 858 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
NATURAL Epsom SaltMAGNESIUM SULFATEUniversal Distribution Center LLCb2682e51-ffa4-4556-b2a6-b0dbd543fd4f2024-10-16WarningsExact identifier
application number: M007
Bliss GVSGLYCERINBliss GVS Pharma Limited1a3982a1-9ce9-4a1a-ba73-ebe2d86471092024-10-10WarningsExact identifier
application number: M007
BisacodylBISACODYLPadagis US LLC7eada0fc-5f83-43da-a56f-b0f5372982082024-10-10WarningsExact identifier
application number: M007
exchange select stool softenerDOCUSATE SODIUMArmy & Air Force Exchange Service14985848-d791-42b9-ad7e-810a85bb1ee12024-10-07WarningsExact identifier
application number: M007
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1245468docusate sodium 250 MG Oral CapsulePSN33000a06-e030-433a-8f9c-7ae5c08037fa4
1245468docusate sodium 250 MG Oral CapsuleSCD33000a06-e030-433a-8f9c-7ae5c08037fa4
1245468DOSS Sodium 250 MG Oral CapsuleSY33000a06-e030-433a-8f9c-7ae5c08037fa4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
59726-059-1059726005910100 CAPSULE, LIQUID FILLED in 1 BOTTLE (59726-059-10) 2021-04-160000-00-00NoNoCurrent