FDA.reportPublic FDA data

DOCUSATE SODIUM

Product NDC
53345-008
11-digit product format
533450008
Labeler code
53345
Product ID
53345-008_2766d54c-3cf9-0b55-e063-6394a90a886d
Type
HUMAN OTC DRUG
Nonproprietary name
DOCUSATE SODIUM
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
Humanwell PuraCap Pharmaceutical (Wuhan), Ltd.
Application
M007
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2013-04-15
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
b10fdf50-289e-41f3-9b83-a4e4dd892f88Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
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
53345-008-01DOCUSATE SODIUM1 in 1 BOXCAPSULE, LIQUID FILLED14
53345-008-01DOCUSATE SODIUM20000 in 1 BAGCAPSULE, LIQUID FILLED200004
53345-008-02DOCUSATE SODIUM15000 in 1 BAGCAPSULE, LIQUID FILLED150004
53345-008-02DOCUSATE SODIUM1 in 1 BOXCAPSULE, LIQUID FILLED14

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DOCUSATE SODIUMACTIVE INGREDIENTF05Q2T2JA0DOCUSATE SODIUM CAPSULE, LIQUID FILLED [HUMANWELL PURACAP PHARMACEUTICAL (WUHAN), LTD.]2
DOCUSATEACTIVE MOIETYM7P27195AGDOCUSATE SODIUM CAPSULE, LIQUID FILLED [HUMANWELL PURACAP PHARMACEUTICAL (WUHAN), LTD.]2
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLDOCUSATE SODIUM CAPSULE, LIQUID FILLED [HUMANWELL PURACAP PHARMACEUTICAL (WUHAN), LTD.]2
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOADOCUSATE SODIUM CAPSULE, LIQUID FILLED [HUMANWELL PURACAP PHARMACEUTICAL (WUHAN), LTD.]2
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8DOCUSATE SODIUM CAPSULE, LIQUID FILLED [HUMANWELL PURACAP PHARMACEUTICAL (WUHAN), LTD.]2
GELATININACTIVE INGREDIENT2G86QN327LDOCUSATE SODIUM CAPSULE, LIQUID FILLED [HUMANWELL PURACAP PHARMACEUTICAL (WUHAN), LTD.]2
GLYCERININACTIVE INGREDIENTPDC6A3C0OXDOCUSATE SODIUM CAPSULE, LIQUID FILLED [HUMANWELL PURACAP PHARMACEUTICAL (WUHAN), LTD.]2
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ADOCUSATE SODIUM CAPSULE, LIQUID FILLED [HUMANWELL PURACAP PHARMACEUTICAL (WUHAN), LTD.]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3DOCUSATE SODIUM CAPSULE, LIQUID FILLED [HUMANWELL PURACAP PHARMACEUTICAL (WUHAN), LTD.]2
SORBITOLINACTIVE INGREDIENT506T60A25RDOCUSATE SODIUM CAPSULE, LIQUID FILLED [HUMANWELL PURACAP PHARMACEUTICAL (WUHAN), LTD.]2
WATERINACTIVE INGREDIENT059QF0KO0RDOCUSATE SODIUM CAPSULE, LIQUID FILLED [HUMANWELL PURACAP PHARMACEUTICAL (WUHAN), LTD.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53345-008DOCUSATE SODIUM CAPSULE, LIQUID FILLED [HUMANWELL PURACAP PHARMACEUTICAL (WUHAN), LTD.]4Current NDC, Legacy NDC, 4 package rows20241123_b10fdf50-289e-41f3-9b83-a4e4dd892f88.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 41 of 42 · 833 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MILK OF MAGNESIAMAGNESIUM HYDROXIDEWal-Mart Stores, Inc.750e0355-369e-b679-e053-2a91aa0a66ca2023-11-01WarningsExact identifier
application number: M007
MILK OF MAGNESIAMAGNESIUM HYDROXIDEWal-Mart Stores, Inc.750efd58-5845-fbc4-e053-2a91aa0a86d12023-11-01WarningsExact identifier
application number: M007
Gentle LaxativeMAGNESIUM HYDROXIDEWALGREEN COMPANYba4a29b3-2ddc-b906-e053-2995a90a2ab72023-11-01WarningsExact identifier
application number: M007
DOCUZENSENNOSIDES 8.6MG AND DOCUSATE SODIUM 50MGProficient Rx LP92879e62-f60a-4ab4-9532-610cdd2628ee2023-11-01WarningsExact identifier
application number: M007
Docusate SodiumDOCUSATE SODIUMA-S Medication Solutions5999904a-6ac8-4d9e-951c-6e64e8cd93eb2023-11-01WarningsExact identifier
application number: M007
MILK OF MAGNESIAMAGNESIUM HYDROXIDEVALU MERCHANDISERS COMPANY5e98f9d9-679c-63a2-e053-2991aa0a4b8d2023-10-31WarningsExact identifier
application number: M007
MILK OF MAGNESIAMAGNESIUM HYDROXIDEVALU MERCHANDISERS COMPANY5e957b01-4f44-0a2a-e053-2991aa0a37a02023-10-31WarningsExact identifier
application number: M007
MILK OF MAGNESIAMAGNESIUM HYDROXIDEVALU MERCHANDISERS COMPANY5e993b13-8dc8-6653-e053-2a91aa0a4c2a2023-10-31WarningsExact identifier
application number: M007
MILK OF MAGNESIAMAGNESIUM HYDROXIDECVS3c8e4144-6702-2678-e054-00144ff88e882023-10-31WarningsExact identifier
application number: M007
Fiber LaxativeCALCIUM POLYCARBOPHILMagno-Humphries, Inc.9d22c208-d089-8b6a-e053-2995a90ab90a2023-10-27WarningsExact identifier
application number: M007
Stool Softener Docusate SodiumDOCUSATE SODIUMMagno-Humphries, Inc.a0e6ab9b-fd31-45fd-93d5-b51d705c180a2023-10-27WarningsExact identifier
application number: M007
Sennosides Natural LaxativeSENNOSIDESMagno-Humphries, Inc.9d22bedb-9fca-8421-e053-2a95a90acf4a2023-10-27WarningsExact identifier
application number: M007
Stool Softener Docusate SodiumDOCUSATE SODIUMMagno-Humphries, Inc.9d22d642-8aed-d17e-e053-2995a90ae1822023-10-27WarningsExact identifier
application number: M007
Senna SDOCUSATE SODIUM, SENNOSIDESMagno-Humphries, Inc.9deaf264-6af0-40ba-e053-2a95a90ada0e2023-10-27WarningsExact identifier
application number: M007
FLEETMINERAL OILC.B. Fleet Company, Inc.2528cb5e-437e-41f0-9c34-e9ce57404d8b2023-10-26WarningsExact identifier
application number: M007
Magnesium CitrateMAJOR MAGNESIUM CITRATE ORAL SOLUTION - LEMONMajor Pharmaceuticals088e5543-c947-af78-e063-6294a90a8bc42023-10-25WarningsExact identifier
application number: M007
DOKDOCUSATE SODIUMMAJOR PHARMACEUTICALS7a92070d-98cc-662f-e053-2991aa0aa1b22023-10-23WarningsExact identifier
application number: M007
Stool SoftenerDOCUSATE SODIUMKROGER COMPANYa1afaa71-7e8c-5a49-e053-2a95a90a4db02023-10-23WarningsExact identifier
application number: M007
Stool SoftenerDOCUSATE SODIUMGeri-Care Pharmaceutical Corp644d81ec-d38f-4172-a087-727b94e2fefe2023-10-19WarningsExact identifier
application number: M007
Docusate SodiumDOCUSATE SODIUMAsclemed USA, Inc.30fc8c07-c26b-4bcc-a727-6e193f5727fd2023-10-16WarningsExact identifier
application number: M007

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1115005docusate sodium 100 MG Oral CapsulePSN97561cd4-63d9-44c2-a3a3-ec668a09a4ed9
1115005docusate sodium 100 MG Oral CapsuleSCD97561cd4-63d9-44c2-a3a3-ec668a09a4ed9
1115005DOSS Sodium 100 MG Oral CapsuleSY97561cd4-63d9-44c2-a3a3-ec668a09a4ed9
1115005docusate sodium 100 MG Oral CapsulePSN056ec3cf-edcf-4a9a-8cfa-7cf9c4a9a1385
1115005docusate sodium 100 MG Oral CapsuleSCD056ec3cf-edcf-4a9a-8cfa-7cf9c4a9a1385
1115005DOSS Sodium 100 MG Oral CapsuleSY056ec3cf-edcf-4a9a-8cfa-7cf9c4a9a1385
1115005docusate sodium 100 MG Oral CapsulePSN816c82f8-0fa5-4b22-a226-e8f22f3eaa1d4
1115005docusate sodium 100 MG Oral CapsulePSNb10fdf50-289e-41f3-9b83-a4e4dd892f884
1115005docusate sodium 100 MG Oral CapsuleSCD816c82f8-0fa5-4b22-a226-e8f22f3eaa1d4
1115005docusate sodium 100 MG Oral CapsuleSCDb10fdf50-289e-41f3-9b83-a4e4dd892f884
1115005DOSS Sodium 100 MG Oral CapsuleSY816c82f8-0fa5-4b22-a226-e8f22f3eaa1d4
1115005DOSS Sodium 100 MG Oral CapsuleSYb10fdf50-289e-41f3-9b83-a4e4dd892f884
1115005docusate sodium 100 MG Oral CapsulePSN88cc2575-27a1-4514-bc41-bd1eac2838143
1115005docusate sodium 100 MG Oral CapsulePSN8066a52d-e683-47c1-905c-290d2d427acf3
1115005docusate sodium 100 MG Oral CapsuleSCD88cc2575-27a1-4514-bc41-bd1eac2838143
1115005docusate sodium 100 MG Oral CapsuleSCD8066a52d-e683-47c1-905c-290d2d427acf3
1115005DOSS Sodium 100 MG Oral CapsuleSY88cc2575-27a1-4514-bc41-bd1eac2838143
1115005DOSS Sodium 100 MG Oral CapsuleSY8066a52d-e683-47c1-905c-290d2d427acf3
1115005docusate sodium 100 MG Oral CapsulePSNd9db24b5-e3b5-47f9-b86b-bc8d70896a112
1115005docusate sodium 100 MG Oral CapsulePSNf4671579-aed0-4f93-ab83-248e0d72b5b02
1115005docusate sodium 100 MG Oral CapsulePSN8b033d56-b95b-4905-9f33-cf2fbd61ce352
1115005docusate sodium 100 MG Oral CapsuleSCDf4671579-aed0-4f93-ab83-248e0d72b5b02
1115005docusate sodium 100 MG Oral CapsuleSCD8b033d56-b95b-4905-9f33-cf2fbd61ce352
1115005docusate sodium 100 MG Oral CapsuleSCDd9db24b5-e3b5-47f9-b86b-bc8d70896a112
1115005DOSS Sodium 100 MG Oral CapsuleSYd9db24b5-e3b5-47f9-b86b-bc8d70896a112
1115005DOSS Sodium 100 MG Oral CapsuleSYf4671579-aed0-4f93-ab83-248e0d72b5b02
1115005DOSS Sodium 100 MG Oral CapsuleSY8b033d56-b95b-4905-9f33-cf2fbd61ce352
1115005docusate sodium 100 MG Oral CapsulePSN946abcdb-96bd-43e6-992a-bb97679c00f01
1115005docusate sodium 100 MG Oral CapsuleSCD946abcdb-96bd-43e6-992a-bb97679c00f01
1115005DOSS Sodium 100 MG Oral CapsuleSY946abcdb-96bd-43e6-992a-bb97679c00f01

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53345-008-01533450008011 BAG in 1 BOX (53345-008-01) / 20000 CAPSULE, LIQUID FILLED in 1 BAG1 bag2013-04-150000-00-00NoNoCurrent
53345-008-02533450008021 BAG in 1 BOX (53345-008-02) / 15000 CAPSULE, LIQUID FILLED in 1 BAG1 bag2013-04-150000-00-00NoNoCurrent