FDA.reportPublic FDA data

DOCUSATE SODIUM

Product NDC
68196-995
11-digit product format
681960995
Labeler code
68196
Product ID
68196-995_77056696-8140-4c66-a342-49a97fa03507
Type
HUMAN OTC DRUG
Nonproprietary name
DOCUSATE SODIUM
Dosage form
CAPSULE
Route
ORAL
Labeler
Sam's West Inc
Application
M007
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2018-02-08
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
b0e99ebb-41fc-459f-86d2-f0e3527f97b0Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68196-995-64DOCUSATE SODIUM600 in 1 BOTTLECAPSULE6004

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68196-995DOCUSATE SODIUM CAPSULE [SAM'S WEST INC]4Current NDC, Legacy NDC, 1 package rows20241025_b0e99ebb-41fc-459f-86d2-f0e3527f97b0.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 40 of 42 · 833 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Milk of Magnesia mintMAGNESIUM HYDROXIDEMeijer, Inc.bb8ba371-f53c-1088-e053-2a95a90a4cbf2023-11-08WarningsExact identifier
application number: M007
MILK OF MAGNESIAMAGNESIUM HYDROXIDESTRATEGIC SOURCING SERVICES LLC00c61622-367b-0a5b-e063-6294a90a67062023-11-08WarningsExact identifier
application number: M007
MILK OF MAGNESIAMAGNESIUM HYDROXIDEStrategic Sourcing Services LLC003a3c0d-7a48-e44d-e063-6394a90a3f4a2023-11-08WarningsExact identifier
application number: M007
MILK OF MAGNESIA MINTMAGNESIUM HYDROXIDEGeri-Care Pharmaceuticals, Corp2d1be236-e136-4727-a52d-714f628800882023-11-08WarningsExact identifier
application number: M007
MILK OF MAGNESIAMAGNESIUM HYDROXIDEAMERISOURCEBERGEN DRUG CORPORATION5d690d82-e4fb-57ad-e053-2a91aa0a38ea2023-11-07WarningsExact identifier
application number: M007
MILK OF MAGNESIA MINTMAGNESIUM HYDROXIDEAMERISOURCEBERGEN DRUG CORPORATION5d6a8048-93e7-42e5-e053-2991aa0acabd2023-11-07WarningsExact identifier
application number: M007
MILK OF MAGNESIA CHERRYMAGNESIUM HYDROXIDEAMERISOURCEBERGEN DRUG CORPORATION5d7f5a38-4222-5bfb-e053-2991aa0a17e32023-11-07WarningsExact identifier
application number: M007
MILK OF MAGNESIA MINTMAGNESIUM HYDROXIDECARDINAL HEALTHaf4b6b64-97c9-a794-e053-2a95a90aaf0b2023-11-07WarningsExact identifier
application number: M007
MILK OF MAGNESIAMAGNESIUM HYDROXIDECARDINAL HEALTHaf5ddf5d-b1f5-2918-e053-2995a90a2d612023-11-07WarningsExact identifier
application number: M007
MILK OF MAGNESIA MINTMAGNESIUM HYDROXIDEH E Bab998776-6b30-9f17-e053-2995a90a96cd2023-11-07WarningsExact identifier
application number: M007
MILK OF MAGNESIAMAGNESIUM HYDROXIDEH E Babfe89c8-86f1-bd1e-e053-2995a90af7732023-11-07WarningsExact identifier
application number: M007
MILK OF MAGNESIAMAGNESIUM HYDROXIDEGOODSENSEa951617d-c6fa-75e0-e053-2995a90afcf82023-11-07WarningsExact identifier
application number: M007
Milk of MagnesiaMAGNESIUM HYDROXIDEKROGER COMPANYa1b04366-ff67-3bb3-e053-2a95a90a816c2023-11-07WarningsExact identifier
application number: M007
MILK OF MAGNESIAMAGNESIUM HYDROXIDEBETTER LIVING BRANDS, LLCb9440381-df40-4bc7-e053-2995a90ae83f2023-11-07WarningsExact identifier
application number: M007
Milk of Magnesia mintMAGNESIUM HYDROXIDETOP CARE (TOPCO ASSOCIATES LLC)b83f6027-51a0-1730-e053-2995a90a553b2023-11-07WarningsExact identifier
application number: M007
MILK OF MAGNESIAMAGNESIUM HYDROXIDETOP CARE (TOPCO ASSOCIATES LLC)b83eb807-d522-4408-e053-2a95a90a79262023-11-07WarningsExact identifier
application number: M007
MILK OF MAGNESIA CHERRYMAGNESIUM HYDROXIDETOP CARE (TOPCO ASSOCIATES LLC)b83f0c1c-0e90-2888-e053-2995a90a0b962023-11-07WarningsExact identifier
application number: M007
MILK OF MAGNESIAMAGNESIUM HYDROXIDEDOLGENCORP, INC.b6991abf-9819-701c-e053-2a95a90ac0b42023-11-07WarningsExact identifier
application number: M007
MILK OF MAGNESIA MINTMAGNESIUM HYDROXIDEChain Drug Marketing Association7722145c-913c-4ed5-a9b2-a6c3430640662023-11-06WarningsExact identifier
application number: M007
MILK OF MAGNESIA CHERRYMAGNESIUM HYDROXIDEChain Drug Marketing Association12361478-d178-4950-9458-4e2e565655992023-11-06WarningsExact identifier
application number: M007

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1115005docusate sodium 100 MG Oral CapsulePSNb0e99ebb-41fc-459f-86d2-f0e3527f97b04
1115005docusate sodium 100 MG Oral CapsuleSCDb0e99ebb-41fc-459f-86d2-f0e3527f97b04
1115005DOSS Sodium 100 MG Oral CapsuleSYb0e99ebb-41fc-459f-86d2-f0e3527f97b04

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68196-995-6468196099564600 CAPSULE in 1 BOTTLE (68196-995-64) 600 capsule2018-02-080000-00-00NoNoCurrent