FDA.reportPublic FDA data

Docusate Sodium

Product NDC
68788-8658
11-digit product format
687888658
Labeler code
68788
Product ID
68788-8658_4229d52a-e957-4ea0-878c-31c6d9010ecd
Type
HUMAN OTC DRUG
Nonproprietary name
Docusate sodium
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
part334
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-05-09
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
4e30b602-1ac2-48e6-a8b0-fd1dc97a3f48Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68788-8658-3Docusate Sodium30 in 1 BOTTLECAPSULE, LIQUID FILLED303
68788-8658-6Docusate Sodium60 in 1 BOTTLECAPSULE, LIQUID FILLED603
68788-8658-9Docusate Sodium100 in 1 BOTTLECAPSULE, LIQUID FILLED1003

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-8658-3EA - Each68788-86581b8dd01c-261e-4abe-97c5-0e9ed4cd4a0b12024-07-12
68788-8658-6EA - Each68788-86587f7d39e7-50c2-490d-82ab-58178ba6496412024-07-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-8658DOCUSATE SODIUM CAPSULE, LIQUID FILLED [PREFERRED PHARMACEUTICALS INC.]2Current NDC, 3 package rows20250403_4e30b602-1ac2-48e6-a8b0-fd1dc97a3f48.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 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Docusate SodiumDOCUSATE SODIUMPreferred Pharmaceuticals Inc.4e30b602-1ac2-48e6-a8b0-fd1dc97a3f482026-04-08WarningsExact identifier
ndc (product): 68788-8658

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
68788-8658-36878886580330 CAPSULE, LIQUID FILLED in 1 BOTTLE (68788-8658-3) 2024-05-09NoNoCurrent
68788-8658-66878886580660 CAPSULE, LIQUID FILLED in 1 BOTTLE (68788-8658-6) 2024-05-09NoNoCurrent
68788-8658-968788865809100 CAPSULE, LIQUID FILLED in 1 BOTTLE (68788-8658-9) 2024-05-09NoNoCurrent