FDA.reportPublic FDA data

Docusate Sodium

Product NDC
63739-478
Requested package NDC
63739-478-02
11-digit product format
637390478
Labeler code
63739
Product ID
63739-478_ca3f4d9b-3ee9-3040-e053-2995a90a4a82
Type
HUMAN OTC DRUG
Nonproprietary name
Docusate Sodium
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
McKesson Corporation
Application
part334
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2010-11-09
Marketing end
0000-00-00
Substance
DOCUSATE SODIUM
Active strength
100 mg/1
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

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

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage63739-47863739-478-02DDiscontinued by firm2026-10-12

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
63739-478-012023-03-24Drug Facts
63739-478-022023-03-24Drug Facts
63739-478-102023-03-24Drug Facts
63739-478-402023-03-24Drug Facts
63739-478-482023-03-24Drug Facts
63739-478-012023-01-30Drug Facts
63739-478-022023-01-30Drug Facts
63739-478-102023-01-30Drug Facts
63739-478-402023-01-30Drug Facts
63739-478-482023-01-30Drug Facts

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63739-478-01EA - Each63739-478bb0a5458-5326-4332-96e8-f4c8db27a33812012-07-24
63739-478-02EA - Each63739-4786ce72269-cb12-4d4c-9885-bd94dc196fd012021-08-05
63739-478-04EA - Each63739-47884e7a142-cef0-4627-a16d-51bf1d56324112012-07-24
63739-478-10EA - Each63739-47814ed252d-3611-448d-ab07-80a2542843a112012-07-24
63739-478-40EA - Each63739-478b49aa50c-70b4-4599-80a0-c1b904ca3f8512017-11-06
63739-478-48EA - Each63739-47808b4cea1-4cb9-4d01-a857-e0f08a45439312017-11-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DOCUSATE SODIUMACTIVE INGREDIENTF05Q2T2JA0DOCUSATE SODIUM CAPSULE, LIQUID FILLED [CARDINAL HEALTH]5
DOCUSATEACTIVE MOIETYM7P27195AGDOCUSATE SODIUM CAPSULE, LIQUID FILLED [CARDINAL HEALTH]5
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GDOCUSATE SODIUM CAPSULE, LIQUID FILLED [CARDINAL HEALTH]5
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOADOCUSATE SODIUM CAPSULE, LIQUID FILLED [CARDINAL HEALTH]5
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8DOCUSATE SODIUM CAPSULE, LIQUID FILLED [CARDINAL HEALTH]5
GELATININACTIVE INGREDIENT2G86QN327LDOCUSATE SODIUM CAPSULE, LIQUID FILLED [CARDINAL HEALTH]5
GLYCERININACTIVE INGREDIENTPDC6A3C0OXDOCUSATE SODIUM CAPSULE, LIQUID FILLED [CARDINAL HEALTH]5
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ADOCUSATE SODIUM CAPSULE, LIQUID FILLED [CARDINAL HEALTH]5
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3DOCUSATE SODIUM CAPSULE, LIQUID FILLED [CARDINAL HEALTH]5
SORBITOLINACTIVE INGREDIENT506T60A25RDOCUSATE SODIUM CAPSULE, LIQUID FILLED [CARDINAL HEALTH]5
WATERINACTIVE INGREDIENT059QF0KO0RDOCUSATE SODIUM CAPSULE, LIQUID FILLED [CARDINAL HEALTH]5
DOCUSATE SODIUMACTIVE INGREDIENTF05Q2T2JA0DOCUSATE SODIUM CAPSULE, LIQUID FILLED [MCKESSON PACKAGING SERVICES BUSINESS UNIT OF MCKESSON CORPORATION]3
DOCUSATEACTIVE MOIETYM7P27195AGDOCUSATE SODIUM CAPSULE, LIQUID FILLED [MCKESSON PACKAGING SERVICES BUSINESS UNIT OF MCKESSON CORPORATION]3
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GDOCUSATE SODIUM CAPSULE, LIQUID FILLED [MCKESSON PACKAGING SERVICES BUSINESS UNIT OF MCKESSON CORPORATION]3
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOADOCUSATE SODIUM CAPSULE, LIQUID FILLED [MCKESSON PACKAGING SERVICES BUSINESS UNIT OF MCKESSON CORPORATION]3
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8DOCUSATE SODIUM CAPSULE, LIQUID FILLED [MCKESSON PACKAGING SERVICES BUSINESS UNIT OF MCKESSON CORPORATION]3
GELATININACTIVE INGREDIENT2G86QN327LDOCUSATE SODIUM CAPSULE, LIQUID FILLED [MCKESSON PACKAGING SERVICES BUSINESS UNIT OF MCKESSON CORPORATION]3
GLYCERININACTIVE INGREDIENTPDC6A3C0OXDOCUSATE SODIUM CAPSULE, LIQUID FILLED [MCKESSON PACKAGING SERVICES BUSINESS UNIT OF MCKESSON CORPORATION]3
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ADOCUSATE SODIUM CAPSULE, LIQUID FILLED [MCKESSON PACKAGING SERVICES BUSINESS UNIT OF MCKESSON CORPORATION]3
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3DOCUSATE SODIUM CAPSULE, LIQUID FILLED [MCKESSON PACKAGING SERVICES BUSINESS UNIT OF MCKESSON CORPORATION]3
SORBITOLINACTIVE INGREDIENT506T60A25RDOCUSATE SODIUM CAPSULE, LIQUID FILLED [MCKESSON PACKAGING SERVICES BUSINESS UNIT OF MCKESSON CORPORATION]3
WATERINACTIVE INGREDIENT059QF0KO0RDOCUSATE SODIUM CAPSULE, LIQUID FILLED [MCKESSON PACKAGING SERVICES BUSINESS UNIT OF MCKESSON CORPORATION]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63739-478DOCUSATE SODIUM CAPSULE, LIQUID FILLED [MCKESSON CORPORATION]12Legacy NDC20250424_48555cc1-a711-411f-a384-550116da1d3c.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63739-478-026373904780230 BLISTER PACK in 1 BOX, UNIT-DOSE (63739-478-02) > 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK30 blister pack2021-07-010000-00-00NoNoCurrent