FDA.reportPublic FDA data

Stool Softener

Product NDC
37808-580
11-digit product format
378080580
Labeler code
37808
Product ID
37808-580_45751ca7-5d7a-ecc4-e063-6294a90aa19b
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

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Stool SoftenerDOCUSATE SODIUMHEB2efb4c5a-2c5e-acf6-e063-6394a90a934e2025-12-08WarningsExact identifier

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

warnings

Warnings Ask a doctor before use if you • have stomach pain, nausea or vomiting • have a sudden change in bowel habits that persists over a period of 2 weeks • are presently taking mineral oil Stop use and ask a doctor if • you need to use a laxative longer than 1 week • you have rectal bleeding or fail to have a bowel movement. These could be signs of a serious condition. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

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 Identifiers#

Field, Values table
FieldValues
UniiF05Q2T2JA0
Rxcui1115005

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
37808-580-01Stool Softener1 in 1 CARTONCAPSULE, LIQUID FILLED12
37808-580-01Stool Softener100 in 1 BOTTLECAPSULE, LIQUID FILLED1002

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1115005docusate sodium 100 MG Oral CapsulePSN2efb4c5a-2c5e-acf6-e063-6394a90a934e2
1115005docusate sodium 100 MG Oral CapsuleSCD2efb4c5a-2c5e-acf6-e063-6394a90a934e2
1115005DOSS Sodium 100 MG Oral CapsuleSY2efb4c5a-2c5e-acf6-e063-6394a90a934e2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
37808-580-01378080580011 BOTTLE in 1 CARTON (37808-580-01) / 100 CAPSULE, LIQUID FILLED in 1 BOTTLE1 bottle2025-09-01NoNoCurrent