Docusate Sodium

Product NDC
45802-486
11-digit product format
458020486
Labeler code
45802
Product ID
45802-486_15d8cf99-c44d-459f-91ca-7fd089897869
Type
HUMAN OTC DRUG
Nonproprietary name
Docusate sodium
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
Padagis Israel Pharmaceuticals Ltd
Application
M007
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2008-10-28
Substance
DOCUSATE SODIUM
Active strength
100 mg/1
NDC exclude flag
No
Listing certified through
2026-12-31
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
2026-12-31

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
bce3b245-ec47-4e62-9cad-bb12d0812c18Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
45802-486-78Docusate Sodium100 in 1 BOTTLECAPSULE, LIQUID FILLED1005

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
45802-486-78EA - Each45802-486efff330d-ac0a-4908-8da3-b9e544bfb32412012-07-24

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
45802-486DOCUSATE SODIUM CAPSULE, LIQUID FILLED [PADAGIS ISRAEL PHARMACEUTICALS LTD]5Current NDC, Legacy NDC, 1 package rows20240817_bce3b245-ec47-4e62-9cad-bb12d0812c18.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 30 of 42 · 833 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Senna-LaxSENNOSIDESGuardian Drug Companyd3ee7288-986e-44a6-8aa2-05405210c8752024-12-19WarningsExact identifier
application number: M007
Quality Choice Stool SoftenerDOCUSATE SODIUMChain Drug Marketing Association4d5facd4-f57f-44f7-b8dd-83a33e57afd92024-12-18WarningsExact identifier
application number: M007
Good Neighbor Pharmacy Gentle LaxativeBISACODYLAmerisourceBergen Drug Corp8336d821-ec70-468e-98b2-512a9a7212e02024-12-18WarningsExact identifier
application number: M007
Good Neighbor Stool SoftenerDOCUSATE SODIUMAmerisourceBergen Drug Corp88d657a1-77be-412a-9295-034872db2dde2024-12-18WarningsExact identifier
application number: M007
Preferred Stool SoftenerDOCUSATE SODIUMReese Pharmaceutical Co217d13a0-3205-492c-af49-82eb80dba53a2024-12-18WarningsExact identifier
application number: M007
Preferred Stool SoftenerDOCUSATE CALCIUMReese Pharmaceutical Co3b481b74-5683-466f-ad74-3da63279ce912024-12-18WarningsExact identifier
application number: M007
Topcare Stool SoftenerDOCUSATE SODIUMTOPCO ASSOCIATES LLC9342c1b5-5d35-4b60-b347-c208c0774cdc2024-12-18WarningsExact identifier
application number: M007
HEB Stool SoftenerDOCUSATE SODIUMH E B3a513cb9-8404-43dc-a780-040bf9f1741d2024-12-18WarningsExact identifier
application number: M007
Topcare Stool Softener laxativeDOCUSATE SODIUMTOPCO ASSOCIATES LLCf9302fc2-684d-4cc2-bdd7-7ad0e9304edb2024-12-18WarningsExact identifier
application number: M007
Good Neighbor Stool Softener laxativeDOCUSATE SODIUMAmerisourceBergen Drug Corpd09151ae-1cc6-4e69-8d80-7813082a42362024-12-18WarningsExact identifier
application number: M007
Dollar General Gentle LaxativeBISACODYLDolgencorp, LLCf1977a2e-942a-49eb-8d0f-cdb67b020a262024-12-18WarningsExact identifier
application number: M007
Discount Drugmart Gentle LaxativeBISACODYLDiscount Drug Mart, Incb525a0a9-f97c-4406-8360-58e87e44cfce2024-12-18WarningsExact identifier
application number: M007
HEB Gentle LaxativeBISACODYLH E B3d163d71-93c7-419f-9707-5811aa6474fb2024-12-18WarningsExact identifier
application number: M007
Winco Stool SoftenerDOCUSATE SODIUMWinCo Foods, LLC4de2e315-5ec6-4ddf-8617-4e07ba4563542024-12-18WarningsExact identifier
application number: M007
Meijer Gentle LaxativeBISACODYLMeijer Distribution Inc.b49786a1-f0b9-45ae-b8f6-683489c54e762024-12-18WarningsExact identifier
application number: M007
H E B Stool Softener laxativeDOCUSATE SODIUMH E B9d848fdd-3a2f-45c6-9ff3-17f1d74e0f4f2024-12-18WarningsExact identifier
application number: M007
Preferred Stool Softener laxativeDOCUSATE SODIUMReese Pharmaceutical Co9135addd-4fc7-411b-b3c3-79e7e0e4cec82024-12-18WarningsExact identifier
application number: M007
DOCUSATE SODIUM 100mg Two-ToneDOCUSATE SODIUMDiscount Drug Mart, Inc80092188-0517-4646-bd46-ab56c63bb3542024-12-18WarningsExact identifier
application number: M007
Winco Stool SoftenerDOCUSATE SODIUMWinCo Foods, LLCd74c54d6-7a75-4ca9-8425-7593b7841b0f2024-12-18WarningsExact identifier
application number: M007
Quality Choice Stool Softener laxativeDOCUSATE SODIUMChain Drug Marketing Association7635b081-4350-45d0-b44e-82afccce21342024-12-18WarningsExact identifier
application number: M007

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1115005docusate sodium 100 MG Oral CapsulePSN122486e9-74dd-4181-97d1-0b07688280f45
1115005docusate sodium 100 MG Oral CapsulePSNbce3b245-ec47-4e62-9cad-bb12d0812c185
1115005docusate sodium 100 MG Oral CapsuleSCD122486e9-74dd-4181-97d1-0b07688280f45
1115005docusate sodium 100 MG Oral CapsuleSCDbce3b245-ec47-4e62-9cad-bb12d0812c185
1115005DOSS Sodium 100 MG Oral CapsuleSY122486e9-74dd-4181-97d1-0b07688280f45
1115005DOSS Sodium 100 MG Oral CapsuleSYbce3b245-ec47-4e62-9cad-bb12d0812c185
1115005docusate sodium 100 MG Oral CapsulePSN4e30b602-1ac2-48e6-a8b0-fd1dc97a3f483
1115005docusate sodium 100 MG Oral CapsuleSCD4e30b602-1ac2-48e6-a8b0-fd1dc97a3f483
1115005DOSS Sodium 100 MG Oral CapsuleSY4e30b602-1ac2-48e6-a8b0-fd1dc97a3f483
1115005docusate sodium 100 MG Oral CapsulePSNf4236180-d2bc-3a1e-e053-2a95a90a84b91
1115005docusate sodium 100 MG Oral CapsuleSCDf4236180-d2bc-3a1e-e053-2a95a90a84b91
1115005DOSS Sodium 100 MG Oral CapsuleSYf4236180-d2bc-3a1e-e053-2a95a90a84b91

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
45802-486-7845802048678100 CAPSULE, LIQUID FILLED in 1 BOTTLE (45802-486-78) 2008-10-280000-00-00NoNoCurrent