FDA.reportPublic FDA data

Stool Softener

Product NDC
50090-7167
11-digit product format
500907167
Labeler code
50090
Product ID
50090-7167_025b5313-4e58-4d50-995f-67ecd69570ae
Type
HUMAN OTC DRUG
Nonproprietary name
Docusate Sodium
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
A-S Medication Solutions
Application
M007
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2000-01-01
Substance
DOCUSATE SODIUM
Active strength
100 mg/1
NDC exclude flag
No
Listing certified through
2026-12-31
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
2026-12-31

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
ef05ad45-7082-43e6-9533-a79c5aa0f373Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-7167-1Stool Softener100 in 1 BOTTLECAPSULE, LIQUID FILLED1003
50090-7167-4Stool Softener30 in 1 BOTTLECAPSULE, LIQUID FILLED303

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-7167-1EA - Each50090-716763f4ef5b-e635-4368-a3af-3e94d8e0e0c212024-06-10
50090-7167-4EA - Each50090-7167192c4db0-abcc-4021-a3d1-3d268d8de48c12024-06-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-7167STOOL SOFTENER (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [A-S MEDICATION SOLUTIONS]3Current NDC, 2 package rows20241024_ef05ad45-7082-43e6-9533-a79c5aa0f373.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 11 of 43 · 858 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CVS PharmacySALINE LAXATIVECVS Pharmacyedd58c52-18de-4ec4-aec3-44f3e17607a72026-02-17WarningsExact identifier
application number: M007
Mineral OilMINERAL OILUnited Natural Foods, Inc. dba UNFIcb7bc571-295f-47c2-ae93-18cba194752c2026-02-17Warnings, Adverse reactionsExact identifier
application number: M007
Mineral OilMINERAL OILStrategic Sourcing Services LLCe4965086-dcc0-4b34-bb30-81facf7139f32026-02-17Warnings, Adverse reactionsExact identifier
application number: M007
Magnesium CitrateMAGNESIUM CITRATEValu Merchandisers Companycd3e5836-b2f0-41f3-8623-3105c46424912026-02-16Warnings, Adverse reactionsExact identifier
application number: M007
citromaMAGESIUM CITRATEValu Merchandisers Companya693f6b0-0679-4609-9ca0-dddfa4158c022026-02-16Warnings, Adverse reactionsExact identifier
application number: M007
citromaMAGNESIUM CITRATEValu Merchandisers Companyfb358bc3-e479-42e7-8aea-a6a3676f24302026-02-16Warnings, Adverse reactionsExact identifier
application number: M007
Epsom SaltMAGNESIUM SULFATEValu Merchandisers Companyff539c1c-9ed3-49be-9b30-1858f12e1e902026-02-16Warnings, Adverse reactionsExact identifier
application number: M007
Castor OilCASTOR OILUnited Natural Foods, Inc. dba UNFIbd19bea3-5ac9-4f8d-b1a0-478fd9c8a01f2026-02-16Warnings, Adverse reactionsExact identifier
application number: M007
Walgreens SmoothLAX Soft ChewsMAGNESIUM HYDROXIDEWalgreens424e27ce-0b11-9cd2-e063-6294a90a3c212026-02-16WarningsExact identifier
application number: M007
citromaMAGNESIUM CITRATEUnited Natural Foods, Inc. dba UNFIda013c15-3531-4dc5-b122-bfc99bc494ae2026-02-16Warnings, Adverse reactionsExact identifier
application number: M007
citromaMAGNESIUM CITRATEUnited Natural Foods, Inc. dba UNFIdb1bc651-1a35-4f92-a917-c6a19f4215942026-02-16Warnings, Adverse reactionsExact identifier
application number: M007
Stool Softener LaxativeDOCUSATE SODIUMThe Kroger Co.e1a68bd9-d31a-46a6-8c08-7ad8197b6e0b2026-02-13WarningsExact identifier
application number: M007
Epsom SaltMAGNESIUM SULFATETopco Associates LLCb2ec06b3-647d-49ab-a392-6db63d96d1e32026-02-13Warnings, Adverse reactionsExact identifier
application number: M007
Castor OilCASTOR OILTopco Associates LLC5643f2e0-93e2-4c2e-90a0-fd152150d18a2026-02-13Warnings, Adverse reactionsExact identifier
application number: M007
citromaMAGESIUM CITRATETopco Associates LLCd3cc7cb6-098e-413c-b1ad-7ebf5fa352692026-02-13Warnings, Adverse reactionsExact identifier
application number: M007
citromaMAGNESIUM CITRATETopco Associates LLCbc89c4bc-5207-479d-9a3b-e570b412a7ba2026-02-13Warnings, Adverse reactionsExact identifier
application number: M007
Epsom SaltMAGNESIUM SULFATETopco Associates LLC72f69aa0-381a-4e5c-975d-3a73fdc1b3772026-02-13Warnings, Adverse reactionsExact identifier
application number: M007
Mineral OilMINERAL OILTopco Associates LLCe9b1fd61-c229-4529-82c2-d6ac5b0760822026-02-13WarningsExact identifier
application number: M007
Magnesium CitrateMAGNESIUM CITRATEPinnacle RX LLC4abbb0e4-e005-bc4e-e063-6394a90a126a2026-02-13Warnings, Adverse reactionsExact identifier
application number: M007
365 Whole Foods Market Epsom SaltMAGNESIUM SULFATEWhole Foods Market, Inc.4147cdd0-57f6-3857-e063-6394a90afecb2026-02-12Warnings, Adverse reactionsExact identifier
application number: M007

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1115005docusate sodium 100 MG Oral CapsulePSNef05ad45-7082-43e6-9533-a79c5aa0f3733
1115005docusate sodium 100 MG Oral CapsuleSCDef05ad45-7082-43e6-9533-a79c5aa0f3733
1115005DOSS Sodium 100 MG Oral CapsuleSYef05ad45-7082-43e6-9533-a79c5aa0f3733

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
50090-7167-150090716701100 CAPSULE, LIQUID FILLED in 1 BOTTLE (50090-7167-1) 2024-05-09NoNoCurrent
50090-7167-45009071670430 CAPSULE, LIQUID FILLED in 1 BOTTLE (50090-7167-4) 2024-05-09NoNoCurrent