FDA.reportPublic FDA data

Docusate Sodium

Product NDC
76420-225
11-digit product format
764200225
Labeler code
76420
Product ID
76420-225_07cec8ef-ecca-ac49-e063-6294a90a6083
Type
HUMAN OTC DRUG
Nonproprietary name
Docusate Sodium
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
Asclemed USA, Inc.
Application
M007
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2000-01-01
Substance
DOCUSATE SODIUM
Active strength
100 mg/1
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
Docusate Sodium
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DOCUSATE SODIUM100 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
F05Q2T2JA0Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1115005Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
30fc8c07-c26b-4bcc-a727-6e193f5727fdAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76420-225-30Docusate Sodium30 in 1 BOTTLECAPSULE, LIQUID FILLED302
76420-225-60Docusate Sodium60 in 1 BOTTLECAPSULE, LIQUID FILLED602
76420-225-90Docusate Sodium90 in 1 BOTTLECAPSULE, LIQUID FILLED902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
76420-225-30EA - Each76420-2258fa84f45-d979-4dec-8243-a7aca044551812022-09-12
76420-225-60EA - Each76420-225ed6e1a5d-d719-44ca-9328-f67821dc73cd12022-09-12
76420-225-90EA - Each76420-2256c2a0546-21b5-466c-840d-d621cc48562912022-09-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76420-225DOCUSATE SODIUM CAPSULE, LIQUID FILLED [ASCLEMED USA, INC.]2Current NDC, Legacy NDC, 3 package rows20231016_30fc8c07-c26b-4bcc-a727-6e193f5727fd.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 2 of 42 · 833 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Epsom SaltMAGNESIUM SULFATECardinal Health, 110 dba Leaderd27dc1cc-5e17-40d3-84fe-c1792552cfd52026-08-25Warnings, Adverse reactionsExact identifier
application number: M007
HyVee Senna SDOCUSATE SODIUM, SENNOSIDESHyVee Inc4982b9c6-ed0e-24da-e063-6394a90a147f2026-08-24WarningsExact identifier
application number: M007
Stool Softener LaxativeDOCUSATE SODIUMDolgencorp, Inc. (DOLLAR GENERAL & REXALL)ccec364a-3135-4a5d-b4b0-86b832387b4e2026-08-24WarningsExact identifier
application number: M007
ColaceDOCUSATE SODIUMAtlantis Consumer Healthcare, Inc.a1591da0-a1a9-9583-3cf5-788b8fee38142026-08-24Exact identifier
application number: M007
MiraFAST soft chewsMAGNESIUM HYDROXIDEBayer HealthCare LLC.2cee67dd-b71f-32b8-e063-6394a90ae8642026-08-21WarningsExact identifier
application number: M007
HyVee Senna SDOCUSATE SODIUM, SENNOSIDESHyVee Inc49837b2c-492f-2fed-e063-6294a90aaa242026-08-21WarningsExact identifier
application number: M007
Senokot-SSTANDARDIZED SENNA CONCENTRATE AND DOCUSATE SODIUMAtlantis Consumer Healthcare, Inc.c24cdc5e-62e0-41a6-8afb-512202a569f42026-08-21WarningsExact identifier
application number: M007
Foster and Thrive Senna-S Sennosides and Docusate Sodium Laxative and Stool SoftenerDOCUSATE SODIUM 50MG AND SENNOSIDES 8.6MGStrategic Sourcing Services LLC5966ff80-7be2-788a-e063-6294a90ab4f32026-08-19WarningsExact identifier
application number: M007
Epsom SaltEPSOM SALTAmerisourceBergen (Good Neighbor Pharmacy) 46122d22fb02f-09c4-476a-b6d6-d3a2fd30049d2026-08-18WarningsExact identifier
application number: M007
FiberconCALCIUM POLYCARBOPHILMedtech Products Inc.59534afd-fe38-818a-e063-6394a90a21ea2026-08-18WarningsExact identifier
application number: M007
CVS Stool Softener Fruit PunchDOCUSATE SODIUMCVS PHARMACY, INC0e6900d6-7dc9-47d6-a006-1695feb8d5a52026-08-17WarningsExact identifier
application number: M007
CVS Senna LaxativeSENNOSIDESCVS PHARMACY5a5565b2-827f-4fcc-a835-d827f62da8f92026-08-17WarningsExact identifier
application number: M007
Stool Softener LaxativeDOCUSATE SODIUMDolgencorp, Inc. (DOLLAR GENERAL & REXALL)306fd12b-ed60-40dc-a5be-2dc394bd29d22026-08-17WarningsExact identifier
application number: M007
CVS Health Childrens Saline LaxativeMAGNESIUM HYDROXIDECVS PHARMACY,INC.e57e5529-2190-4c66-8397-bc2848739e592026-08-14WarningsExact identifier
application number: M007
Docusate Sodium and SennosidesDOCUSATE SODIUM AND SENNOSIDESMorepen Bio Inc562d1b9a-09d8-92fc-e063-6394a90a19932026-08-14WarningsExact identifier
application number: M007
CVS HealthNATURAL FIBER SUPPLEMENTCVS Pharmacy,Inc.04dbe9aa-ed18-4d76-a840-d010445a86432026-08-14WarningsExact identifier
application number: M007
CVS Fiber TherapyMETHYLCELLULOSECVS PHARMACYe066f5bd-5f34-4e04-beec-3c7d6db493812026-08-13WarningsExact identifier
application number: M007
Mineral oilMINERAL OILEQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)92f2147d-b52d-4282-b217-28f6095dca0e2026-08-12WarningsExact identifier
application number: M007
CAREONE Orange FlavoredPSYLLIUM HUSKFOODHOLD USA4b1cccd2-e941-4d51-9924-4ca35e3a44292026-08-11WarningsExact identifier
application number: M007
CAREONEPSYLLIUM HUSKFOODHOLD USA3ec3ead0-382e-4765-bbe8-b21e7c7b42a62026-08-11WarningsExact identifier
application number: M007

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1115005docusate sodium 100 MG Oral CapsulePSN30fc8c07-c26b-4bcc-a727-6e193f5727fd2
1115005docusate sodium 100 MG Oral CapsuleSCD30fc8c07-c26b-4bcc-a727-6e193f5727fd2
1115005DOSS Sodium 100 MG Oral CapsuleSY30fc8c07-c26b-4bcc-a727-6e193f5727fd2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
76420-225-307642002253030 CAPSULE, LIQUID FILLED in 1 BOTTLE (76420-225-30) 2022-07-070000-00-00NoNoCurrent
76420-225-607642002256060 CAPSULE, LIQUID FILLED in 1 BOTTLE (76420-225-60) 2022-07-070000-00-00NoNoCurrent
76420-225-907642002259090 CAPSULE, LIQUID FILLED in 1 BOTTLE (76420-225-90) 2022-07-070000-00-00NoNoCurrent