Stool Softener

Product NDC
36800-651
11-digit product format
368000651
Labeler code
36800
Product ID
36800-651_f46eeb50-19e7-45ca-8750-f50a33f6555a
Type
HUMAN OTC DRUG
Nonproprietary name
Docusate Sodium
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
TOP CARE (Topco Associates LLC)
Application
M007
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-12-01
Substance
DOCUSATE SODIUM
Active strength
100 mg/1
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Stool Softener
Listing expiration
2027-12-31

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
36800-651-25Stool Softener1 in 1 BOXCAPSULE, LIQUID FILLED13
36800-651-25Stool Softener25 in 1 BOTTLE, PLASTICCAPSULE, LIQUID FILLED253

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1115005docusate sodium 100 MG Oral CapsulePSN0ce164a5-6b2f-4a21-9dca-10301a1f812a3
1115005docusate sodium 100 MG Oral CapsuleSCD0ce164a5-6b2f-4a21-9dca-10301a1f812a3
1115005DOSS Sodium 100 MG Oral CapsuleSY0ce164a5-6b2f-4a21-9dca-10301a1f812a3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
36800-651-25368000651251 BOTTLE, PLASTIC in 1 BOX (36800-651-25) / 25 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC2025-12-01NoNoCurrent