Stool Softener Laxative

Product NDC
0615-8557
11-digit product format
006158557
Labeler code
0615
Product ID
0615-8557_90878e80-57b1-4bb3-a052-76fa593d0f67
Type
HUMAN OTC DRUG
Nonproprietary name
DOCUSATE SODIUM
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
NCS HealthCare of KY, LLC dba Vangard Labs
Application
M007
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-11-15
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 Laxative
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DOCUSATE SODIUM100 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiF05Q2T2JA0
Rxcui1115005

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0615-8557-30Stool Softener Laxative5 in 1 BLISTER PACKCAPSULE, LIQUID FILLED53
0615-8557-30Stool Softener Laxative6 in 1 BOX, UNIT-DOSECAPSULE, LIQUID FILLED63
0615-8557-39Stool Softener Laxative30 in 1 BLISTER PACKCAPSULE, LIQUID FILLED303

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0615-8557STOOL SOFTENER LAXATIVE (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [NCS HEALTHCARE OF KY, LLC DBA VANGARD LABS]2Current NDC, 3 package rows20250122_4d678da0-9ada-4d00-9db9-33b45c776107.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1115005docusate sodium 100 MG Oral CapsulePSN4d678da0-9ada-4d00-9db9-33b45c7761073
1115005docusate sodium 100 MG Oral CapsuleSCD4d678da0-9ada-4d00-9db9-33b45c7761073
1115005DOSS Sodium 100 MG Oral CapsuleSY4d678da0-9ada-4d00-9db9-33b45c7761073

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
0615-8557-30006158557305 in 1 BLISTER PACKHistorical
0615-8557-390061585573930 CAPSULE, LIQUID FILLED in 1 BLISTER PACK (0615-8557-39) 2024-12-11NoNoHistorical