FDA.reportPublic FDA data

DOCUSATE SODIUM 100mg

Product NDC
53345-029
11-digit product format
533450029
Labeler code
53345
Product ID
53345-029_27c7bf94-6590-15d9-e063-6394a90a5776
Type
HUMAN OTC DRUG
Nonproprietary name
DOCUSATE SODIUM
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd.
Application
M007
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2015-01-28
Substance
DOCUSATE SODIUM
Active strength
100 mg/1
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
DOCUSATE SODIUM 100mg
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
c5bdfbfc-d24a-4088-9b60-ecea8120ff43Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53345-029-01DOCUSATE SODIUM 100mg1 in 1 BOXCAPSULE, LIQUID FILLED15
53345-029-01DOCUSATE SODIUM 100mg20000 in 1 BAGCAPSULE, LIQUID FILLED200005
53345-029-02DOCUSATE SODIUM 100mg1 in 1 BOXCAPSULE, LIQUID FILLED15
53345-029-02DOCUSATE SODIUM 100mg15000 in 1 BAGCAPSULE, LIQUID FILLED150005

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DOCUSATE SODIUMACTIVE INGREDIENTF05Q2T2JA0DOCUSATE SODIUM 100MG (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [HUMANWELL PURACAP PHARMACEUTICAL (WUHAN) CO., LTD.]3
DOCUSATEACTIVE MOIETYM7P27195AGDOCUSATE SODIUM 100MG (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [HUMANWELL PURACAP PHARMACEUTICAL (WUHAN) CO., LTD.]3
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLDOCUSATE SODIUM 100MG (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [HUMANWELL PURACAP PHARMACEUTICAL (WUHAN) CO., LTD.]3
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOADOCUSATE SODIUM 100MG (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [HUMANWELL PURACAP PHARMACEUTICAL (WUHAN) CO., LTD.]3
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8DOCUSATE SODIUM 100MG (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [HUMANWELL PURACAP PHARMACEUTICAL (WUHAN) CO., LTD.]3
GELATININACTIVE INGREDIENT2G86QN327LDOCUSATE SODIUM 100MG (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [HUMANWELL PURACAP PHARMACEUTICAL (WUHAN) CO., LTD.]3
GLYCERININACTIVE INGREDIENTPDC6A3C0OXDOCUSATE SODIUM 100MG (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [HUMANWELL PURACAP PHARMACEUTICAL (WUHAN) CO., LTD.]3
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ADOCUSATE SODIUM 100MG (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [HUMANWELL PURACAP PHARMACEUTICAL (WUHAN) CO., LTD.]3
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3DOCUSATE SODIUM 100MG (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [HUMANWELL PURACAP PHARMACEUTICAL (WUHAN) CO., LTD.]3
SORBITOLINACTIVE INGREDIENT506T60A25RDOCUSATE SODIUM 100MG (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [HUMANWELL PURACAP PHARMACEUTICAL (WUHAN) CO., LTD.]3
WATERINACTIVE INGREDIENT059QF0KO0RDOCUSATE SODIUM 100MG (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [HUMANWELL PURACAP PHARMACEUTICAL (WUHAN) CO., LTD.]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53345-029DOCUSATE SODIUM 100MG (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [HUMANWELL PURACAP PHARMACEUTICAL (WUHAN) CO., LTD.]5Current NDC, Legacy NDC, 4 package rows20241127_c5bdfbfc-d24a-4088-9b60-ecea8120ff43.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 44 · 872 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MiraFAST KIDS soft chewsMAGNESIUM HYDROXIDEBayer HealthCare LLC.58636827-239d-cc63-e063-6294a90a61802026-08-06WarningsExact identifier
application number: M007
Stool Softener Extra StrengthDOCUSATE SODIUMP & L Development, LLC4e97dd60-96e3-4b51-b614-c62480af19192026-08-06WarningsExact identifier
application number: M007
Stool Softener LaxativeDOCUSATE SODIUMP & L Development, LLC098d2377-0019-45fe-b995-700b1b1241c42026-08-05WarningsExact identifier
application number: M007
Docusate Sodium softgels 50mg (Dye Free)DOCUSATE SODIUMCVS Pharmacy273ea95f-3c9c-98e8-e063-6294a90a21352026-08-05WarningsExact identifier
application number: M007
Mineral OilMINERAL OILOld East Main Co.4bae831d-caba-40c9-bdb5-2611eac35dd52026-08-05Warnings, Adverse reactionsExact identifier
application number: M007
MiraFAST soft chewsMAGNESIUM HYDROXIDEBayer HealthCare LLC.2cee67dd-b71f-32b8-e063-6394a90ae8642026-08-05WarningsExact identifier
application number: M007
MiraSOFT Stool SoftenerDOCUSATE SODIUMBayer HealthCare LLC.5851f15f-8add-559f-e063-6394a90a7b7d2026-08-05WarningsExact identifier
application number: M007
Stool Softener LaxativeDOCUSATE SODIUMP & L Development, LLCcbb0edf4-1fa7-42f5-a6f7-027e3961b50a2026-08-05WarningsExact identifier
application number: M007
Metamucil Therapy for regularityPSYLLIUM HUSKAtlantic Biologicals Corp.57b112ea-f6b1-baa6-e063-6394a90a3b292026-08-04WarningsExact identifier
application number: M007
SennosidesSENNOSIDESLEADER/ Cardinal Health 110, Inc.e3c7ece8-82f3-cd0c-e053-2995a90ad8002026-08-04WarningsExact identifier
application number: M007
ColaceDOCUSATE SODIUMAtlantis Consumer Healthcare, Inc.7793fced-e8ee-44e2-b212-dd2a59a5f4622026-08-04WarningsExact identifier
application number: M007
Dual Action Senna Stool SoftenerDOCUSATE SODIUM 50 MG, SENNOSIDES 8.6 MGShield Pharmaceuticals Corpa04435df-aace-497f-a3a8-d8e8489db6612026-08-03WarningsExact identifier
application number: M007
Docusate Sodium - Stool Softener LaxativeDOCUSATE SODIUMCardinal Health 107, LLCb5e4b14d-bf11-4309-bf6d-65ee9d877a242026-07-28WarningsExact identifier
application number: M007
Topwin Speedy EnemaGLYCERINHealth Chemical Pharmaceutical Co., Ltd3ba8c3d2-1780-42e1-bec5-8f98771d475e2026-07-27WarningsExact identifier
application number: M007
Curewell Senna SyrupSENNOSIDESRMT HEALTH LLC57345324-5140-5cde-e063-6294a90ab97c2026-07-22WarningsExact identifier
application number: M007
Magnesium CitrateMAGNESIUM CITRATE ORAL SOLUTIONWALGREEN COMPANY4ffe54ae-3126-ba58-e063-6294a90a88772026-07-20WarningsExact identifier
application number: M007
Stool Softener LaxativeDOCUSATE SODIUMBryant Ranch Prepackdeca083b-5c72-40fa-9021-b74028426a5a2026-07-20WarningsExact identifier
application number: M007
Docusate SodiumDOCUSATE SODIUMCardinal Health 107, LLCfc5e82b6-e25c-4686-9781-2205819685f52026-07-20WarningsExact identifier
application number: M007
Best Choice Fiber Therapy Orange FlavorPSYLLIUM HUSKBEST CHOICE (VALU MERCHANDISERS COMPANY)0b25f6c0-441b-41ef-ab19-2a29705a56c62026-07-17WarningsExact identifier
application number: M007
Best Choice Fiber Therapy original coarsePSYLLIUM HUSKBEST CHOICE (VALU MERCHANDISERS COMPANY)d7eb71af-17e3-465e-b464-f77b3be7266d2026-07-17WarningsExact identifier
application number: M007

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1115005docusate sodium 100 MG Oral CapsulePSNc5bdfbfc-d24a-4088-9b60-ecea8120ff435
1115005docusate sodium 100 MG Oral CapsuleSCDc5bdfbfc-d24a-4088-9b60-ecea8120ff435
1115005DOSS Sodium 100 MG Oral CapsuleSYc5bdfbfc-d24a-4088-9b60-ecea8120ff435

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53345-029-01533450029011 BAG in 1 BOX (53345-029-01) / 20000 CAPSULE, LIQUID FILLED in 1 BAG1 bag2015-01-280000-00-00NoNoCurrent
53345-029-02533450029021 BAG in 1 BOX (53345-029-02) / 15000 CAPSULE, LIQUID FILLED in 1 BAG1 bag2015-01-280000-00-00NoNoCurrent