FDA.reportPublic FDA data

Stool Softener

Product NDC
76168-069
11-digit product format
761680069
Labeler code
76168
Product ID
76168-069_5d5cb3d5-4364-4980-93b0-c75f5c482601
Type
HUMAN OTC DRUG
Nonproprietary name
Docusate Sodium
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
Velocity Pharma
Application
part334
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2013-04-01
Marketing end
0000-00-00
Substance
DOCUSATE SODIUM
Active strength
100 mg/1
NDC exclude flag
No
Listing certified through
2019-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
76168-069-052020-01-31C16284748780-19d75b9d0-b620-f424-e053-dadaa90a57ceDocusate Sodium, USP 100mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76168-069-05Stool Softener25 in 1 BOTTLECAPSULE, LIQUID FILLED252
76168-069-05Stool Softener1 in 1 CARTONCAPSULE, LIQUID FILLED12

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DOCUSATE SODIUMACTIVE INGREDIENTF05Q2T2JA0STOOL SOFTENER (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [VELOCITY PHARMA]2
DOCUSATEACTIVE MOIETYM7P27195AGSTOOL SOFTENER (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [VELOCITY PHARMA]2
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOASTOOL SOFTENER (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [VELOCITY PHARMA]2
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8STOOL SOFTENER (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [VELOCITY PHARMA]2
GELATININACTIVE INGREDIENT2G86QN327LSTOOL SOFTENER (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [VELOCITY PHARMA]2
GLYCERININACTIVE INGREDIENTPDC6A3C0OXSTOOL SOFTENER (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [VELOCITY PHARMA]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOSTOOL SOFTENER (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [VELOCITY PHARMA]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3STOOL SOFTENER (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [VELOCITY PHARMA]2
SORBITOLINACTIVE INGREDIENT506T60A25RSTOOL SOFTENER (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [VELOCITY PHARMA]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPSTOOL SOFTENER (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [VELOCITY PHARMA]2
WATERINACTIVE INGREDIENT059QF0KO0RSTOOL SOFTENER (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [VELOCITY PHARMA]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76168-069STOOL SOFTENER (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [VELOCITY PHARMA]2Legacy NDC, 2 package rows20130516_7684b17d-ab3f-4202-ba75-7d0603c63e92.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1115005docusate sodium 100 MG Oral CapsulePSN7684b17d-ab3f-4202-ba75-7d0603c63e922
1115005docusate sodium 100 MG Oral CapsuleSCD7684b17d-ab3f-4202-ba75-7d0603c63e922
1115005DOSS Sodium 100 MG Oral CapsuleSY7684b17d-ab3f-4202-ba75-7d0603c63e922

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
76168-069-057616800690525 in 1 BOTTLEHistorical