FDA.reportPublic FDA data

Stool Softener

Product NDC
0536-1065
Requested package NDC
0536-1065-10
11-digit product format
005361065
Labeler code
0536
Product ID
0536-1065_85bad6d2-5e32-470d-9f58-7285b90c454e
Type
HUMAN OTC DRUG
Nonproprietary name
Docusate calcium
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
Rugby Laboratories, Inc.
Application
part334
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2015-01-31
Marketing end
2024-02-23
Substance
DOCUSATE CALCIUM
Active strength
240 mg/1
NDC exclude flag
No
Listing certified through
0000-00-00
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage0536-10650536-1065-10DDiscontinued by firm2026-07-31

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0536-1065-01EA - Each0536-1065db131ae2-b8fb-45a7-b687-4a15ec7f2d0c12015-07-20
0536-1065-05EA - Each0536-1065be573f16-82eb-4c7c-a516-17ca49e8cd5a12015-07-20
0536-1065-10EA - Each0536-1065ff946148-60be-4615-af5a-1920e17c277212015-09-10

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DOCUSATE CALCIUMACTIVE INGREDIENT6K7YS503HCSTOOL SOFTENER (DOCUSATE CALCIUM) CAPSULE, LIQUID FILLED [RUGBY LABORATORIES, INC.]2
DOCUSATEACTIVE MOIETYM7P27195AGSTOOL SOFTENER (DOCUSATE CALCIUM) CAPSULE, LIQUID FILLED [RUGBY LABORATORIES, INC.]2
CORN OILINACTIVE INGREDIENT8470G57WFMSTOOL SOFTENER (DOCUSATE CALCIUM) CAPSULE, LIQUID FILLED [RUGBY LABORATORIES, INC.]2
D&C RED NO. 33INACTIVE INGREDIENT9DBA0SBB0LSTOOL SOFTENER (DOCUSATE CALCIUM) CAPSULE, LIQUID FILLED [RUGBY LABORATORIES, INC.]2
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDSTOOL SOFTENER (DOCUSATE CALCIUM) CAPSULE, LIQUID FILLED [RUGBY LABORATORIES, INC.]2
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOASTOOL SOFTENER (DOCUSATE CALCIUM) CAPSULE, LIQUID FILLED [RUGBY LABORATORIES, INC.]2
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8STOOL SOFTENER (DOCUSATE CALCIUM) CAPSULE, LIQUID FILLED [RUGBY LABORATORIES, INC.]2
GELATININACTIVE INGREDIENT2G86QN327LSTOOL SOFTENER (DOCUSATE CALCIUM) CAPSULE, LIQUID FILLED [RUGBY LABORATORIES, INC.]2
GLYCERININACTIVE INGREDIENTPDC6A3C0OXSTOOL SOFTENER (DOCUSATE CALCIUM) CAPSULE, LIQUID FILLED [RUGBY LABORATORIES, INC.]2
SORBITANINACTIVE INGREDIENT6O92ICV9RUSTOOL SOFTENER (DOCUSATE CALCIUM) CAPSULE, LIQUID FILLED [RUGBY LABORATORIES, INC.]2
SORBITOLINACTIVE INGREDIENT506T60A25RSTOOL SOFTENER (DOCUSATE CALCIUM) CAPSULE, LIQUID FILLED [RUGBY LABORATORIES, INC.]2
WATERINACTIVE INGREDIENT059QF0KO0RSTOOL SOFTENER (DOCUSATE CALCIUM) CAPSULE, LIQUID FILLED [RUGBY LABORATORIES, INC.]2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0536-1065-10005361065101000 CAPSULE, LIQUID FILLED in 1 BOTTLE (0536-1065-10) 2015-01-312024-02-23NoNoCurrent