Stool Softener

Product NDC
37808-582
11-digit product format
378080582
Labeler code
37808
Product ID
37808-582_4576eb34-9199-8cf6-e063-6394a90ae2c3
Type
HUMAN OTC DRUG
Nonproprietary name
Docusate Sodium
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
HEB
Application
M007
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-09-01
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
2f10041a-8c88-09a5-e063-6294a90a07ccAvailable 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
37808-582-01Stool Softener100 in 1 BOTTLECAPSULE, LIQUID FILLED1002
37808-582-01Stool Softener1 in 1 CARTONCAPSULE, LIQUID FILLED12

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 9 of 42 · 833 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Stool Softener plus Stimulant LaxativeDOCUSATE SODIUM 50 MG AND SENNOSIDES 8.6 MGCARDINAL HEALTH, 110 DBA LEADER3fd9ba76-42f8-4ebe-b1bc-f81f08e702ce2026-03-06WarningsExact identifier
application number: M007
Magnesium CitrateEQUATE MAGNESIUM CITRATE ORAL SOLUTION - LEMONWalmart Inc.484d0421-59ea-3783-e063-6394a90af6332026-03-04WarningsExact identifier
application number: M007
Magnesium CitrateEQUATE MAGNESIUM CITRATE ORAL SOLUTION - CHERRYWalmart Inc.484c2586-9e6f-1ce5-e063-6394a90a0d812026-03-04WarningsExact identifier
application number: M007
Magnesium CitrateEQUATE MAGNESIUM CITRATE ORAL SOLUTION - GRAPEWalmart Inc.450ddcbd-7ccd-3670-e063-6294a90ac2bd2026-03-04WarningsExact identifier
application number: M007
Epsom SaltMAGNESIUM SULFATEAmazon.com Services LLC787ec4b0-c6c5-44ab-a53d-d6d25304f95e2026-03-03Warnings, Adverse reactionsExact identifier
application number: M007
citromaMAGNESIUM CITRATEOld East Main Co.3d0d63d7-640d-4e54-a6fd-6b265c79be092026-03-02Warnings, Adverse reactionsExact identifier
application number: M007
citromaMAGNESIUM CITRATEOld East Main Co.9b3b6cea-ab83-4b7c-a425-fd0ac7df426c2026-03-02Warnings, Adverse reactionsExact identifier
application number: M007
citromaMAGNESIUM CITRATEOld East Main Co.51ed515b-cc51-4ea1-b612-0904761350052026-03-02Warnings, Adverse reactionsExact identifier
application number: M007
Epsom SaltMAGNESIUM SULFATEOld East Main Co.a8af6e2d-0052-4fc9-a51a-c9dbeb1ad3f52026-03-02Warnings, Adverse reactionsExact identifier
application number: M007
citromaMAGNESIUM CITRATEChain Drug Marketing Association629c5817-13b7-4527-8998-93131ee3529e2026-02-27Warnings, Adverse reactionsExact identifier
application number: M007
citromaMAGNESIUM CITRATEChain Drug Marketing Association4df97cdc-e7a2-4350-8f95-a679cdcaff642026-02-27Warnings, Adverse reactionsExact identifier
application number: M007
citromaMAGNESIUM CITRATEChain Drug Marketing Association46b26b44-e065-4337-a071-fa036f8971402026-02-27Warnings, Adverse reactionsExact identifier
application number: M007
Magnesium CitrateMAGNESIUM CITRATEChain Drug Marketing Associationef163b24-ce92-4cbc-b45a-4fae3b5119492026-02-27Warnings, Adverse reactionsExact identifier
application number: M007
Epsom SaltMAGNESIUM SULFATEChain Drug Marketing Association4ee26633-8eb1-4c68-a768-20460404533a2026-02-27Warnings, Adverse reactionsExact identifier
application number: M007
Mineral OilMINERAL OILChain Drug Marketing Association3bfdad9c-ac58-4e92-b952-555e8a8351cd2026-02-27Warnings, Adverse reactionsExact identifier
application number: M007
Magnesium CitrateMAGNESIUM CITRATEThe Kroger Co.2bcab227-42b6-4bff-8363-f6800665755b2026-02-27Warnings, Adverse reactionsExact identifier
application number: M007
Magnesium CitrateMAGNESIUM CITRATEThe Kroger Co.a87dceb2-da73-4d3a-b87c-db2af10471bf2026-02-27Warnings, Adverse reactionsExact identifier
application number: M007
SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEThe Kroger Co.3ae7e275-7bbc-4e62-b30f-013c40a899492026-02-27WarningsExact identifier
application number: M007
SennosidesSENNOSIDESCVS Pharmacy, Inc0b7736df-c7de-7d00-e063-6294a90aa57e2026-02-26WarningsExact identifier
application number: M007
DOCUSATE SODIUMDOCUSATE SODIUMPD-Rx Pharmaceuticals, Inc.5d300ea7-78eb-4e19-8333-1e42c73c4c542026-02-26WarningsExact identifier
application number: M007

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1115005docusate sodium 100 MG Oral CapsulePSN2f10041a-8c88-09a5-e063-6294a90a07cc2
1115005docusate sodium 100 MG Oral CapsuleSCD2f10041a-8c88-09a5-e063-6294a90a07cc2
1115005DOSS Sodium 100 MG Oral CapsuleSY2f10041a-8c88-09a5-e063-6294a90a07cc2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
37808-582-01378080582011 BOTTLE in 1 CARTON (37808-582-01) / 100 CAPSULE, LIQUID FILLED in 1 BOTTLE1 bottle2025-09-01NoNoCurrent