FDA.reportPublic FDA data

stool softener

Product NDC
49348-122
11-digit product format
493480122
Labeler code
49348
Product ID
49348-122_f3e95e81-407b-4f13-a3d3-5f4b79bf841f
Type
HUMAN OTC DRUG
Nonproprietary name
DOCUSATE CALCIUM
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
Strategic Sourcing Services LLC
Application
part334
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2014-05-30
Marketing end
2021-12-30
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct49348-122DDiscontinued by firm2026-07-31
excluded packagepackage49348-12249348-122-10DDiscontinued by firm2026-07-31

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49348-122-10EA - Each49348-12289fe5425-70a9-42db-9e29-2db715e1175a12015-10-02

DailyMed Socrata Ingredients#

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1245376docusate calcium 240 MG Oral CapsulePSN69129a39-b1d7-4212-a97e-813bd08de4a11
1245376docusate calcium 240 MG Oral CapsuleSCD69129a39-b1d7-4212-a97e-813bd08de4a11
1245376DOSS Calcium 240 MG Oral CapsuleSY69129a39-b1d7-4212-a97e-813bd08de4a11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49348-122-10493480122101 BOTTLE in 1 BOX (49348-122-10) > 100 CAPSULE, LIQUID FILLED in 1 BOTTLE1 bottle2014-05-302021-12-30NoNoCurrent