Docusate Sodium - Stool Softener Laxative

Product NDC
0904-7183
11-digit product format
009047183
Labeler code
0904
Product ID
0904-7183_362b3bf1-c0d0-4dee-a2c9-093d772a8b56
Type
HUMAN OTC DRUG
Nonproprietary name
Docusate Sodium
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
Major Pharmaceuticals
Application
M007
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-09-04
Marketing end
2027-08-31
Substance
DOCUSATE SODIUM
Active strength
100 mg/1
NDC exclude flag
No
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
Docusate Sodium - Stool Softener Laxative

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
cc8d1556-f108-4166-837c-48f81152877eAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0904-7183-61Docusate Sodium - Stool Softener Laxative10 in 1 BLISTER PACKCAPSULE, LIQUID FILLED105
0904-7183-61Docusate Sodium - Stool Softener Laxative10 in 1 CARTONCAPSULE, LIQUID FILLED105

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-7183-61EA - Each0904-7183da67df6d-a60f-4a39-8851-7609176262e612021-10-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0904-7183DOCUSATE SODIUM - STOOL SOFTENER LAXATIVE (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [MAJOR PHARMACEUTICALS]3Current NDC, Legacy NDC, 2 package rows20250110_cc8d1556-f108-4166-837c-48f81152877e.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 31 of 42 · 833 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Rite Aid Stool SoftenerDOCUSATE CALCIUMRite Aid281b2bc7-4980-4205-a33f-cb1974af8d062024-12-18WarningsExact identifier
application number: M007
Topcare Stool SoftenerDOCUSATE SODIUMTOPCO ASSOCIATES LLC93158bd3-c830-4b12-ab1c-133a4bdb9c782024-12-18WarningsExact identifier
application number: M007
HEB Stool SoftenerDOCUSATE SODIUMH E Bafc54b8e-03d9-418c-9322-97d68f9290312024-12-18WarningsExact identifier
application number: M007
Foster and Thrive Gentle LaxativeBISACODYLStrategic Sourcing Services LLCd03c2c42-d9d9-4b4b-a6ae-31d99425a2282024-12-18WarningsExact identifier
application number: M007
EX-LAX REGULAR STRENGTH CHOCOLATED STIMULANT LAXATIVESENNOSIDESHaleon US Holdings LLC59a26a7f-516f-4507-8dec-f40cf6cfaffc2024-12-17WarningsExact identifier
application number: M007
EX-LAX MAXIMUM STRENGTH STIMULANT LAXATIVESENNOSIDESHaleon US Holdings LLCfb170340-c996-46cf-b165-84e136ba41512024-12-17WarningsExact identifier
application number: M007
Senna SyrupNATURAL VEGETABLE LAXATIVEBryant Ranch Prepack7d1f092e-0e5b-4fed-a095-64449751582d2024-12-16WarningsExact identifier
application number: M007
Drug Mart Vegetable Laxative plus Stool SoftenerDOCUSATE SODIUM, SENNOSIDESDiscount Drug Mart, Inc1b6d59e8-112f-447f-b6e9-526b7d3bd01e2024-12-13WarningsExact identifier
application number: M007
Drug Mart Stool Softener plus Stimulant LaxativeDOCUSATE SODIUM, SENNOSIDESDiscount Drug Mart, Inccaf74258-922c-4b69-9bd6-57b3e918c7a62024-12-13WarningsExact identifier
application number: M007
Docusate SodiumDOCUSATE SODIUMNational Vitamin Company0c66642c-82cb-42cd-82bb-5f95852cc5d12024-12-12WarningsExact identifier
application number: M007
Foster and Thrive Fiber Laxative 147CALCIUM POLYCARBOPHILStrategic Sourcing Services LLC88d341a6-28aa-4a20-bfed-1d5f3106c2ae2024-12-12WarningsExact identifier
application number: M007
Pedia-LaxSODIUM PHOSPHATE, DIBASIC AND SODIUM PHOSPHATE, MONOBASICC.B. Fleet Company, Inc.f001a37d-8ed4-428b-af12-d6a83c22c1272024-12-12WarningsExact identifier
application number: M007
Careone Milk of magnesia Original Milk of Magnesia OriginalMAGNESIUM HYDROXIDERetail Business Services, LLC.13ffb00b-7c6f-47aa-bc82-2402d121a7582024-12-11WarningsExact identifier
application number: M007
CareOne Milk of Magnesia CherryMAGNESIUM HYDROXIDERetail Business Services, LLC.1822f90d-f693-48d7-b338-a3f2ddfac4df2024-12-11WarningsExact identifier
application number: M007
MILK OF MAGNESIA MINTMAGNESIUM HYDROXIDEGOOD SENSEa951b6d0-9182-e1bc-e053-2a95a90a12b12024-12-09WarningsExact identifier
application number: M007
SennosidesSENNOSIDESMajor Pharmaceuticalsdf3b431b-a1ad-91dd-e053-2995a90aa02f2024-12-06WarningsExact identifier
application number: M007
milk of magnesiaMAGNESIUM HYDROXIDECVS Pharmacyb3a36251-edd6-4201-8da1-85d7a6ede1732024-12-05WarningsExact identifier
application number: M007
CITRUCELMETHYLCELLULOSEHaleon US Holdings LLCd27f6742-2dcc-451e-b803-6ffe183038ec2024-12-05WarningsExact identifier
application number: M007
LaxacinDOCUSATE SODIUM AND SENNOSIDESAlexso, Inc0df9abaf-3997-4dde-8003-ae3d8d07cf392024-12-04WarningsExact identifier
application number: M007
NuValu Epsom SaltMAGNESIUM SULFATE (HEPTAHYDRATE)J C SALES9f3cf9a4-e5c0-41ff-9fd3-63efb0d973cd2024-12-04WarningsExact identifier
application number: M007

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1115005docusate sodium 100 MG Oral CapsulePSNb5e4b14d-bf11-4309-bf6d-65ee9d877a245
1115005docusate sodium 100 MG Oral CapsulePSNcc8d1556-f108-4166-837c-48f81152877e5
1115005docusate sodium 100 MG Oral CapsuleSCDb5e4b14d-bf11-4309-bf6d-65ee9d877a245
1115005docusate sodium 100 MG Oral CapsuleSCDcc8d1556-f108-4166-837c-48f81152877e5
1115005DOSS Sodium 100 MG Oral CapsuleSYb5e4b14d-bf11-4309-bf6d-65ee9d877a245
1115005DOSS Sodium 100 MG Oral CapsuleSYcc8d1556-f108-4166-837c-48f81152877e5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0904-7183-610090471836110 BLISTER PACK in 1 CARTON (0904-7183-61) / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK10 blister pack2021-09-042027-08-31NoNoCurrent