FDA.reportPublic FDA data

Stool Softener Laxative

Product NDC
70677-1095
11-digit product format
706771095
Labeler code
70677
Product ID
70677-1095_62b6d6c3-d888-4358-90d2-7ac0a046b8bf
Type
HUMAN OTC DRUG
Nonproprietary name
Docusate Sodium
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
Strategic Sourcing Services LLC
Application
M007
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-03-01
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 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
70677-1095-1Stool Softener Laxative100 in 1 BOTTLE, PLASTICCAPSULE, LIQUID FILLED1003
70677-1095-2Stool Softener Laxative250 in 1 BOTTLE, PLASTICCAPSULE, LIQUID FILLED2503

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70677-1095-1EA - Each70677-1095bff1561a-4e78-4a1b-8654-99e3187c838412023-09-05
70677-1095-2EA - Each70677-1095eeed03d0-f58c-40a0-92d8-3a187ec37fc412023-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70677-1095STOOL SOFTENER LAXATIVE (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [STRATEGIC SOURCING SERVICES LLC]2Current NDC, 2 package rows20240601_ba51cca1-b70b-476e-80e6-20cd52292e65.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1115005docusate sodium 100 MG Oral CapsulePSNba51cca1-b70b-476e-80e6-20cd52292e653
1115005docusate sodium 100 MG Oral CapsuleSCDba51cca1-b70b-476e-80e6-20cd52292e653
1115005DOSS Sodium 100 MG Oral CapsuleSYba51cca1-b70b-476e-80e6-20cd52292e653

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
70677-1095-170677109501100 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (70677-1095-1) 2023-03-01NoNoHistorical
70677-1095-270677109502250 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (70677-1095-2) 2023-03-01NoNoHistorical