FDA.reportPublic FDA data

Stool Softener Laxative

Product NDC
0363-4100
11-digit product format
003634100
Labeler code
0363
Product ID
0363-4100_dba5a864-8145-44a3-8c89-42870b53ad19
Type
HUMAN OTC DRUG
Nonproprietary name
Docusate Sodium
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
Walgreens
Application
M007
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-12-31
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
92df761b-da68-4ce9-b02a-a5a74fd6620eAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0363-4100-20Stool Softener Laxative200 in 1 BOTTLE, PLASTICCAPSULE, LIQUID FILLED2008
0363-4100-40Stool Softener Laxative400 in 1 BOTTLE, PLASTICCAPSULE, LIQUID FILLED4008
0363-4100-60Stool Softener Laxative1 in 1 BOXCAPSULE, LIQUID FILLED18
0363-4100-60Stool Softener Laxative60 in 1 BOTTLE, PLASTICCAPSULE, LIQUID FILLED608

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0363-4100-40EA - Each0363-410080e6ceb4-bbdf-4dd4-bef6-991983e510ac12023-04-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-4100STOOL SOFTENER LAXATIVE (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [WALGREENS]5Current NDC, Legacy NDC, 4 package rows20231020_92df761b-da68-4ce9-b02a-a5a74fd6620e.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 39 of 42 · 833 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Magnesium CitrateFRESKARO MAGNESIUM CITRATE ORAL SOLUTION - GRAPEPharma Nobis, LLCf0488c86-6c74-3987-e053-2a95a90a31b42023-12-22WarningsExact identifier
application number: M007
Mineral Oil HeavyMINERAL OILPharma Nobis, LLCe42f6c6d-c4de-02c6-e053-2995a90a3ace2023-12-22WarningsExact identifier
application number: M007
Quality Choice Castor OilCASTOR OILChain Drug Market Asociation18d7124f-7745-45b2-adc4-cb1103add5d62023-12-20WarningsExact identifier
application number: M007
Premiere Value Castor OilCASTOR OILChain Drug Consortium5c8c1564-fcff-894b-e053-2991aa0a9c0b2023-12-20WarningsExact identifier
application number: M007
Magnesium CitrateBE HEALTH MAGNESIUM CITRATE ORAL SOLUTION - CHERRYBionpharma, Inc.f0fa4b72-50a5-5c42-e053-2995a90a159a2023-12-20WarningsExact identifier
application number: M007
Harris Teeter Castor OilCASTOR OILHarris Teeter, LLC5cca6b4b-d88f-1c7d-e053-2991aa0a051f2023-12-20WarningsExact identifier
application number: M007
Magnesium CitrateBE HEALTH MAGNESIUM CITRATE ORAL SOLUTION - LEMONBionpharma, Inc.f0f9c36e-c43b-05d2-e053-2995a90a6d652023-12-20WarningsExact identifier
application number: M007
Magnesium CitrateBE HEALTH MAGNESIUM CITRATE ORAL SOLUTION - GRAPEBionpharma, Inc.f0f9ff19-ae08-0af0-e053-2a95a90ab8422023-12-20WarningsExact identifier
application number: M007
CVS Mineral OilMINERAL OILCVS9d7402e1-524b-1084-e053-2a95a90ae3af2023-12-20WarningsExact identifier
application number: M007
Top Care Castor OilCASTOR OILTOPCO ASSOCIATES LLC8dce1a1f-e765-9c75-e053-2995a90abf9f2023-12-18WarningsExact identifier
application number: M007
Humco Epson SaltMAGNESIUM SULFATEHumco Holding Group, Inc.7a9d1b77-6c39-46f1-86f2-4059dde20f852023-12-15WarningsExact identifier
application number: M007
Humco Mineral Oil HeavyMINERAL OILHumco Holding Group, Inc.9f943fdf-5058-4e18-ba96-6be112bf72ca2023-12-15WarningsExact identifier
application number: M007
Rite Aid Castor OilCASTOR OILRite Aid Corporation.5e0d3664-b01b-ba28-e053-2991aa0a8a4c2023-12-15WarningsExact identifier
application number: M007
GNP Castor OilCASTOR OILAmerisource Bergen5d06bec6-f1e7-4f0c-e053-2991aa0a8ad82023-12-14WarningsExact identifier
application number: M007
SankaijoDOCUSATE SODIUM, SENNOSIDESSato Pharmaceutical Co., Ltd.83c0d52b-f7e2-40b0-a01b-1ccee78f8f1b2023-11-29WarningsExact identifier
application number: M007
SIMPEX Bisacodyl laxativeBISACODYLSimpex Pharma Pvt. Ltd5114ed64-4fec-401b-8a91-8df3e42b10b12023-11-29WarningsExact identifier
application number: M007
Stool SoftenerDOCUSATE SODIUMGeri-Care Pharmaceutical Corpb595063a-5fee-18c2-e053-2a95a90a5b992023-11-15WarningsExact identifier
application number: M007
MILK OF MAGNESIAMAGNESIUM HYDROXIDEPublixcbf7dcef-7623-b333-e053-2a95a90a0f1a2023-11-08WarningsExact identifier
application number: M007
MILK OF MAGNESIAMAGNESIUM HYDROXIDEMeijer, Inc.bb8b51e9-ba4a-270d-e053-2a95a90a318b2023-11-08WarningsExact identifier
application number: M007
MILK OF MAGNESIAMAGNESIUM HYDROXIDESTRATEGIC SOURCING SERVICES LLCff0d4b9f-7ce8-dd98-e053-6394a90ab6142023-11-08WarningsExact identifier
application number: M007

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1115005docusate sodium 100 MG Oral CapsulePSN92df761b-da68-4ce9-b02a-a5a74fd6620e8
1115005docusate sodium 100 MG Oral CapsuleSCD92df761b-da68-4ce9-b02a-a5a74fd6620e8
1115005DOSS Sodium 100 MG Oral CapsuleSY92df761b-da68-4ce9-b02a-a5a74fd6620e8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0363-4100-2000363410020200 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (0363-4100-20) 2020-12-310000-00-00NoNoCurrent
0363-4100-4000363410040400 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (0363-4100-40) 2020-12-310000-00-00NoNoCurrent
0363-4100-60003634100601 BOTTLE, PLASTIC in 1 BOX (0363-4100-60) / 60 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC2020-12-310000-00-00NoNoCurrent