Stool Softener Laxative

Product NDC
21130-041
11-digit product format
211300041
Labeler code
21130
Product ID
21130-041_785f0ec2-8f6f-4d90-b059-1982cdc22377
Type
HUMAN OTC DRUG
Nonproprietary name
DOCUSATE SODIUM
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
Safeway, Inc.
Application
M007
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-01-31
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
12ab9c3c-1f4b-43cd-83ac-b5f80b1aa54cAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810
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
21130-041-20Stool Softener Laxative200 in 1 BOTTLE, PLASTICCAPSULE, LIQUID FILLED2004
21130-041-60Stool Softener Laxative60 in 1 BOTTLE, PLASTICCAPSULE, LIQUID FILLED604
21130-041-60Stool Softener Laxative1 in 1 BOXCAPSULE, LIQUID FILLED14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21130-041STOOL SOFTENER LAXATIVE (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [SAFEWAY, INC.]3Current NDC, Legacy NDC, 3 package rows20240404_12ab9c3c-1f4b-43cd-83ac-b5f80b1aa54c.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 17 of 42 · 833 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DDM Castor OilCASTOR OILDiscount Drug Mart5d1583fa-968a-5987-e053-2991aa0a0d602025-12-19WarningsExact identifier
application number: M007
Stool Softener LaxativeDOCUSATE SODIUMP & L Development, LLCcb0765cb-f48e-4daa-97b8-2897a2d955872025-12-19WarningsExact identifier
application number: M007
Humco Castor OilCASTOR OILHumco holding Group, Inc.f2676cf2-f6fb-46b8-b723-5497f16559022025-12-18WarningsExact identifier
application number: M007
Humco Castor Oil (Regular)CASTOR OILHumco Holding Group, Inc.ccf25c1f-d8a2-49b9-8e09-88e6616c9ade2025-12-18WarningsExact identifier
application number: M007
Meijer Magnesium Hydroxide Laxative Soft ChewMAGNESIUM HYDROXIDEMeijer23f826c3-1ad5-b3c8-e063-6394a90a655e2025-12-18WarningsExact identifier
application number: M007
Stool Softener LaxativeDOCUSATE SODIUMStrategic Sourcing Services LLCba51cca1-b70b-476e-80e6-20cd52292e652025-12-17WarningsExact identifier
application number: M007
Stool Softener Extra StrengthDOCUSATE SODIUMCVS Pharmacya694b4f3-6112-4a1d-a06e-9e5b20fd3d7b2025-12-17WarningsExact identifier
application number: M007
Stool Softener LaxativeDOCUSATE SODIUMCARDINAL HEALTH 110, LLC. DBA LEADER 70000da5ccd75-8a2f-4f90-ae8a-97d81b8579d22025-12-17WarningsExact identifier
application number: M007
SennosidesSENNOSIDESMorepen Laboratories Limited3643eabf-e339-f02c-e063-6394a90aa6a82025-12-16WarningsExact identifier
application number: M007
Magnesium CitrateMAGNESIUM CITRATEMeijer Distribution Incf425a7aa-2503-2fe8-e053-2995a90ab3522025-12-16WarningsExact identifier
application number: M007
Magnesium CitrateMAGNESIUM CITRATEMeijer Distribution Inc.f42591f9-c842-018f-e053-2995a90a480f2025-12-16WarningsExact identifier
application number: M007
MILK OF MAGNESIA ORIGINALMAGNESIUM HYDROXIDEMAJOR Pharmaceuticals Inc.673311f7-0b83-410c-a480-8e57d01902962025-12-11WarningsExact identifier
application number: M007
GeriCare Docusate Sodium LiquidDOCUSATE SODIUMGERI-CARE PHARMACEUTICALS, CORPd599ff49-c9a4-401a-a50b-63d89749bbed2025-12-11WarningsExact identifier
application number: M007
GeriCare Senna SyrupSENNOSIDESGeri-Care Pharmaceutical Corp.05a54614-a6ad-4861-87b8-9e2ee49bad202025-12-11WarningsExact identifier
application number: M007
Docusate SodiumDOCUSATE SODIUMMajor Pharmaceuticals3e8321cf-7eda-d70c-e063-6394a90a35a52025-12-10WarningsExact identifier
application number: M007
Stool SoftenerDOCUSATE SODIUMHEB2f103a88-4cab-d4b9-e063-6394a90ac7fc2025-12-09WarningsExact identifier
application number: M007
Stool SoftenerDOCUSATE SODIUMHEB2efb4c5a-2c5e-acf6-e063-6394a90a934e2025-12-08WarningsExact identifier
application number: M007
Stool SoftenerDOCUSATE SODIUMHEB2f10041a-8c88-09a5-e063-6294a90a07cc2025-12-08WarningsExact identifier
application number: M007
QUALITY CHOICE Fiber TherapyMETHYLCELLULOSECHAIN DRUG MARKETING ASSOCIATION77ac079c-d957-4706-8241-570d7fcfe3aa2025-12-04WarningsExact identifier
application number: M007
Phillips Stool Softener Bulk DocusateDOCUSATE SODIUMBayer HealthCare LLC.b0462555-5554-4a17-a1fe-4206a4fd350d2025-12-04WarningsExact identifier
application number: M007

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1115005docusate sodium 100 MG Oral CapsulePSN12ab9c3c-1f4b-43cd-83ac-b5f80b1aa54c4
1115005docusate sodium 100 MG Oral CapsuleSCD12ab9c3c-1f4b-43cd-83ac-b5f80b1aa54c4
1115005DOSS Sodium 100 MG Oral CapsuleSY12ab9c3c-1f4b-43cd-83ac-b5f80b1aa54c4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
21130-041-2021130004120200 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (21130-041-20) 2021-01-310000-00-00NoNoCurrent
21130-041-60211300041601 BOTTLE, PLASTIC in 1 BOX (21130-041-60) / 60 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC2021-01-31NoNoCurrent