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

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 bottle2025-09-01NoNoHistorical