FDA.reportPublic FDA data

stool softener

Product NDC
49348-280
11-digit product format
493480280
Labeler code
49348
Product ID
49348-280_05990ba5-4433-477e-9ab0-d740a13b6479
Type
HUMAN OTC DRUG
Nonproprietary name
DOCUSATE CALCIUM
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
Mckesson (Sunmark)
Application
part334
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2010-07-09
Marketing end
0000-00-00
Substance
DOCUSATE CALCIUM
Active strength
240 mg/1
NDC exclude flag
No
Listing certified through
2019-12-31
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 productproduct49348-280DDiscontinued by firm2026-07-31
excluded packagepackage49348-28049348-280-10DDiscontinued by firm2026-07-31

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
49348-280-102024-05-28C16284748780-19d75b9d0-2e69-f424-e053-dadaa90a57ceDRUG FACTS
49348-280-102020-01-31C16284748780-19d75b9d0-2e69-f424-e053-dadaa90a57ceDRUG FACTS

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49348-280-10EA - Each49348-28032b785d2-9724-43e0-a2fa-d241c7b121f512013-02-13

DailyMed Socrata Ingredients#

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