FDA.reportPublic FDA data

Stool Softener

Product NDC
0363-0868
11-digit product format
003630868
Labeler code
0363
Product ID
0363-0868_563861bc-b844-403a-907b-d4f985a0da9e
Type
HUMAN OTC DRUG
Nonproprietary name
DOCUSATE CALCIUM
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
Walgreens
Application
M007
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-01-31
Substance
DOCUSATE CALCIUM
Active strength
240 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 CALCIUM240 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
6K7YS503HCInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1245376Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
2791223a-7ac0-47e5-9a6a-4d9a02cfeb63Available 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
0363-0868-10Stool Softener100 in 1 BOTTLE, PLASTICCAPSULE, LIQUID FILLED1004
0363-0868-10Stool Softener1 in 1 BOXCAPSULE, LIQUID FILLED14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-0868STOOL SOFTENER (DOCUSATE CALCIUM) CAPSULE, LIQUID FILLED [WALGREENS]4Current NDC, Legacy NDC, 2 package rows20240627_2791223a-7ac0-47e5-9a6a-4d9a02cfeb63.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 15 of 42 · 833 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CVS Gentle LaxativeBISACODYLCVS Pharmacy0cca1516-fc8d-4471-bd37-a6230fd225e22026-01-14WarningsExact identifier
application number: M007
Rite-Aid Gentle LaxativeBISACODYLRITE AID PHARMACY0fb853db-8d97-64d6-e063-6294a90abeb52026-01-14WarningsExact identifier
application number: M007
Rite-Aid Glycerin LaxativeGLYCERIN SUPPOSITORYRITE AID CORPORATION0fb8f488-3386-29b9-e063-6294a90a014c2026-01-14WarningsExact identifier
application number: M007
Rite-Aid Childrens Glycerin LaxativeGLYCERIN SUPPOSITORYRITE AID CORPORATION0fbe4dfd-1d5d-fc31-e063-6394a90ab3172026-01-14WarningsExact identifier
application number: M007
Stool SoftenerDOCUSATE SODIUMTOP CARE (Topco Associates LLC)92659389-c36f-499b-b284-5b520e50e9a62026-01-14WarningsExact identifier
application number: M007
Senna SyrupSENNOSIDESAVPAKaf75d33f-b081-4b9d-bc12-d2829fa1f0cf2026-01-09WarningsExact identifier
application number: M007
Stool Softener LaxativeDOCUSATE SODIUMCare One (Retail Business Services, LLC.)597d2e9c-1adb-4c7d-ada3-de5c2db69c742026-01-09WarningsExact identifier
application number: M007
Foster and Thrive Ready to Use Mineral oil LaxativeMINERAL OILStrategic Sourcing Services LLCea6da66c-6825-4cd7-8791-45b537bf203a2026-01-08WarningsExact identifier
application number: M007
Sunmark Saline Single LaxativeSODIUM PHOSPHATE, DIBASIC AND SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORMStrategic Sourcing Services LLC06720229-7d58-499e-b7de-cb4bda5ae4162026-01-08WarningsExact identifier
application number: M007
HealthMart Mineral Oil Single LaxativeMINERAL OILStrategic Sourcing Services LLC1238ec69-1ea3-4773-9f13-71f0ae0a35532026-01-08WarningsExact identifier
application number: M007
HealthMart Saline Single LaxativeSODIUM PHOSPHATE, DIBASIC AND SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORMStrategic Sourcing Services LLC689228de-1f3e-4205-853d-6004d62488572026-01-08WarningsExact identifier
application number: M007
Stool Softener LaxativeDOCUSATE SODIUMCVS Pharmacyc445864f-fc88-4885-9f40-d189b9dc42902026-01-07WarningsExact identifier
application number: M007
Stool Softener LaxativeDOCUSATE SODIUMUnited Natural Foods, Inc. dba UNFIc46a1f7c-12e3-4be1-b9e4-d3edac0f43862026-01-07WarningsExact identifier
application number: M007
Stool Softener LaxativeDOCUSATE SODIUMTOP CARE (Topco Associates LLC)44fe6ce0-5fed-418f-8a6a-d6132e2883282026-01-07WarningsExact identifier
application number: M007
Stool SoftenerDOCUSATE SODIUMStrategic Sourcing Services LLC24e29f00-f1cf-4e92-bd67-3f6f820af7832026-01-07WarningsExact identifier
application number: M007
Stool Softener Laxative Extra StrengthDOCUSATE SODIUMP & L Development, LLC33000a06-e030-433a-8f9c-7ae5c08037fa2026-01-06WarningsExact identifier
application number: M007
Stool Softener Regular StrengthDOCUSATE SODIUMSam's West, Inc1eca5910-b0bf-4e07-8211-36dba52b3de72026-01-06WarningsExact identifier
application number: M007
Milk of MagnesiaMAGNESIUM HYDROXIDEMajor Pharmaceuticalsc3d14605-fdec-49fc-b0ee-d4c3ae5f42b52026-01-05WarningsExact identifier
application number: M007
GeriCare Sorbitol SolutionSORBITOLGERI-CARE PHARMACEUTICALS, CORPb4dd7a41-380e-d94b-e053-2a95a90ac34a2025-12-31WarningsExact identifier
application number: M007
Docusate Sodium LiquidDOCUSATE SODIUMLLORENS PHARMACEUTICALS INTERNATIONAL DIVISION2d8bdd3e-f6e6-43f5-b3b0-e5a882cae41c2025-12-31WarningsExact identifier
application number: M007

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1245376docusate calcium 240 MG Oral CapsulePSN2791223a-7ac0-47e5-9a6a-4d9a02cfeb634
1245376docusate calcium 240 MG Oral CapsuleSCD2791223a-7ac0-47e5-9a6a-4d9a02cfeb634
1245376DOSS Calcium 240 MG Oral CapsuleSY2791223a-7ac0-47e5-9a6a-4d9a02cfeb634

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0363-0868-10003630868101 BOTTLE, PLASTIC in 1 BOX (0363-0868-10) / 100 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC2020-01-310000-00-00NoNoCurrent