FDA.reportPublic FDA data

Stool Softener

Product NDC
36800-651
11-digit product format
368000651
Labeler code
36800
Product ID
36800-651_f46eeb50-19e7-45ca-8750-f50a33f6555a
Type
HUMAN OTC DRUG
Nonproprietary name
Docusate Sodium
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
TOP CARE (Topco Associates LLC)
Application
M007
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-12-01
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
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
0ce164a5-6b2f-4a21-9dca-10301a1f812aAvailable 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
36800-651-25Stool Softener1 in 1 BOXCAPSULE, LIQUID FILLED13
36800-651-25Stool Softener25 in 1 BOTTLE, PLASTICCAPSULE, LIQUID FILLED253

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 23 of 42 · 833 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MILK OF MAGNESIAMAGNESIUM HYDROXIDEH E Bab995d9a-1e40-2b38-e053-2a95a90a87e42025-08-21WarningsExact identifier
application number: M007
SenokotSTANDARDIZED SENNA CONCENTRATEAtlantis Consumer Healthcare, Inc.d5bf67e5-82c6-edbf-e9ec-e027fdd47c842025-08-20WarningsExact identifier
application number: M007
Stool SoftenerDOCUSATE SODIUMBJWC (Berkley & Jensen / BJ's)330758d2-fc1a-50ce-e063-6294a90a7db12025-08-19WarningsExact identifier
application number: M007
Sennosides and Docusate SodiumSENNOSIDES AND DOCUSATE SODIUMAmerican Health Packaging4b84d5d7-43cf-47bb-af59-088550c3a0bc2025-08-12WarningsExact identifier
application number: M007
Stool Softener LaxativeDOCUSATE SODIUMGood Sense (Geiss, Destin & Dunn, Inc.)8066a52d-e683-47c1-905c-290d2d427acf2025-08-12WarningsExact identifier
application number: M007
ProlaxaDOCUSATE SODIUM 250MGAdvanced Rx of Tennessee, LLC3ba0c0d9-9e6f-a2e6-e063-6394a90a202d2025-08-05WarningsExact identifier
application number: M007
Dulcolax Stool SoftenerDOCUSATE SODIUMChattem, Inc.86cb7102-3585-4757-9c37-5bf9776bbe632025-08-01WarningsExact identifier
application number: M007
LEADER Mineral OilMINERAL OILCardinal Health, 110 dba Leader7d4f8fa3-8203-5523-e053-2991aa0aba1a2025-07-28WarningsExact identifier
application number: M007
Rapidol Sal InglesaMAGNESIUM SULFATE HEPTAHYDRATEPharmadel LLC1d4ef5f0-54c5-4838-e063-6394a90a44a82025-07-28WarningsExact identifier
application number: M007
Enemeez KidsDOCUSATE SODIUMQuest Products LLCf1602ba4-ad02-2936-e053-2995a90a27f22025-07-15WarningsExact identifier
application number: M007
SennosidesSENNOSIDESBryant Ranch Prepackd4ab04e4-b78a-4afc-aa16-d9dc8fb6cc102025-07-14WarningsExact identifier
application number: M007
Epsom SaltEPSOM SALTStrategic Sourcing Services LLC1515fadd-a7a5-4502-afe2-cfcd50d5bfc82025-07-11WarningsExact identifier
application number: M007
Quality Choice Fiber CapletsCALCIUM POLYCARBOPHILQUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)29dbc831-23c1-487d-902a-9404d9ebe8052025-07-09WarningsExact identifier
application number: M007
Rexall Ready to use 4pk LAXATIVESODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM AND SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORMDolgencorp, LLC78509915-0ef1-4238-99a5-78a49a68f98f2025-07-07WarningsExact identifier
application number: M007
Sal Inglesa EPSOM SALTMAGNESIUM SULFATE HEPTAHYDRATEMenper Distributors, Inc247aa3a3-d38f-4799-b44d-dfe18324fd0c2025-07-01WarningsExact identifier
application number: M007
Stool Softener Extra StrengthDOCUSATE SODIUMChain Drug Consortium, LLC550000ba-0d6d-4666-8461-f591c14478b12025-06-27WarningsExact identifier
application number: M007
Epsom SaltMAGNESIUM SULFATEChain Drug Consortium, LLCc9807e6e-9dcc-41a2-8956-b61623ac21762025-06-27WarningsExact identifier
application number: M007
Stool Softener LaxativeDOCUSATE SODIUMChain Drug Consortium, LLC09449649-fd57-4446-8264-6c3bdd6621d02025-06-27WarningsExact identifier
application number: M007
SennaSENNOSIDESBryant Ranch Prepackf2b14378-2b60-4533-b232-8c8647fbce782025-06-26WarningsExact identifier
application number: M007
Stool Softener LaxativeDOCUSATE SODIUMTARGET CORPORATION28fce2e2-2101-df88-e063-6394a90aa3de2025-06-25WarningsExact identifier
application number: M007

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1115005docusate sodium 100 MG Oral CapsulePSN0ce164a5-6b2f-4a21-9dca-10301a1f812a3
1115005docusate sodium 100 MG Oral CapsuleSCD0ce164a5-6b2f-4a21-9dca-10301a1f812a3
1115005DOSS Sodium 100 MG Oral CapsuleSY0ce164a5-6b2f-4a21-9dca-10301a1f812a3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
36800-651-25368000651251 BOTTLE, PLASTIC in 1 BOX (36800-651-25) / 25 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC2025-12-01NoNoCurrent