FDA.reportPublic FDA data

Stool Softener

Product NDC
37808-585
11-digit product format
378080585
Labeler code
37808
Product ID
37808-585_4589467b-a9e7-ec2b-e063-6394a90ade30
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
250 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 SODIUM250 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiF05Q2T2JA0
Rxcui1245468

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
37808-585-14Stool Softener140 in 1 BOTTLECAPSULE, LIQUID FILLED1402

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1245468docusate sodium 250 MG Oral CapsulePSN2f103a88-4cab-d4b9-e063-6394a90ac7fc2
1245468docusate sodium 250 MG Oral CapsuleSCD2f103a88-4cab-d4b9-e063-6394a90ac7fc2
1245468DOSS Sodium 250 MG Oral CapsuleSY2f103a88-4cab-d4b9-e063-6394a90ac7fc2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
37808-585-1437808058514140 CAPSULE, LIQUID FILLED in 1 BOTTLE (37808-585-14) 2025-09-01NoNoHistorical