FDA.reportPublic FDA data

DOCUSATE SODIUM 100mg Two-Tone

Product NDC
53345-023
11-digit product format
533450023
Labeler code
53345
Product ID
53345-023_27c7853d-1060-f670-e063-6394a90aa99f
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
2014-08-11
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 100mg Two-Tone
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
a923e5ca-86fd-4bf9-9931-180ddfdeae66Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53345-023-02DOCUSATE SODIUM 100mg Two-Tone1 in 1 BOXCAPSULE, LIQUID FILLED15
53345-023-02DOCUSATE SODIUM 100mg Two-Tone15000 in 1 BAGCAPSULE, LIQUID FILLED150005
53345-023-01DOCUSATE SODIUM 100mg Two-Tone1 in 1 BOXCAPSULE, LIQUID FILLED13
53345-023-01DOCUSATE SODIUM 100mg Two-Tone20000 in 1 BAGCAPSULE, LIQUID FILLED200003

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DOCUSATE SODIUMACTIVE INGREDIENTF05Q2T2JA0DOCUSATE SODIUM 100MG TWO-TONE (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [HUMANWELL PURACAP PHARMACEUTICAL (WUHAN) CO., LTD.]3
DOCUSATEACTIVE MOIETYM7P27195AGDOCUSATE SODIUM 100MG TWO-TONE (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [HUMANWELL PURACAP PHARMACEUTICAL (WUHAN) CO., LTD.]3
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLDOCUSATE SODIUM 100MG TWO-TONE (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [HUMANWELL PURACAP PHARMACEUTICAL (WUHAN) CO., LTD.]3
D&C RED NO. 33INACTIVE INGREDIENT9DBA0SBB0LDOCUSATE SODIUM 100MG TWO-TONE (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [HUMANWELL PURACAP PHARMACEUTICAL (WUHAN) CO., LTD.]3
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDDOCUSATE SODIUM 100MG TWO-TONE (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [HUMANWELL PURACAP PHARMACEUTICAL (WUHAN) CO., LTD.]3
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOADOCUSATE SODIUM 100MG TWO-TONE (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [HUMANWELL PURACAP PHARMACEUTICAL (WUHAN) CO., LTD.]3
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8DOCUSATE SODIUM 100MG TWO-TONE (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [HUMANWELL PURACAP PHARMACEUTICAL (WUHAN) CO., LTD.]3
GELATININACTIVE INGREDIENT2G86QN327LDOCUSATE SODIUM 100MG TWO-TONE (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [HUMANWELL PURACAP PHARMACEUTICAL (WUHAN) CO., LTD.]3
GLYCERININACTIVE INGREDIENTPDC6A3C0OXDOCUSATE SODIUM 100MG TWO-TONE (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [HUMANWELL PURACAP PHARMACEUTICAL (WUHAN) CO., LTD.]3
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ADOCUSATE SODIUM 100MG TWO-TONE (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [HUMANWELL PURACAP PHARMACEUTICAL (WUHAN) CO., LTD.]3
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3DOCUSATE SODIUM 100MG TWO-TONE (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [HUMANWELL PURACAP PHARMACEUTICAL (WUHAN) CO., LTD.]3
SORBITOLINACTIVE INGREDIENT506T60A25RDOCUSATE SODIUM 100MG TWO-TONE (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [HUMANWELL PURACAP PHARMACEUTICAL (WUHAN) CO., LTD.]3
WATERINACTIVE INGREDIENT059QF0KO0RDOCUSATE SODIUM 100MG TWO-TONE (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [HUMANWELL PURACAP PHARMACEUTICAL (WUHAN) CO., LTD.]3
DOCUSATE SODIUMACTIVE INGREDIENTF05Q2T2JA0DOCUSATE SODIUM 100MG TWO-TONE (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [HUMANWELL PURACAP PHARMACEUTICAL (WUHAN), LTD.]1
DOCUSATEACTIVE MOIETYM7P27195AGDOCUSATE SODIUM 100MG TWO-TONE (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [HUMANWELL PURACAP PHARMACEUTICAL (WUHAN), LTD.]1
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLDOCUSATE SODIUM 100MG TWO-TONE (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [HUMANWELL PURACAP PHARMACEUTICAL (WUHAN), LTD.]1
D&C RED NO. 33INACTIVE INGREDIENT9DBA0SBB0LDOCUSATE SODIUM 100MG TWO-TONE (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [HUMANWELL PURACAP PHARMACEUTICAL (WUHAN), LTD.]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOADOCUSATE SODIUM 100MG TWO-TONE (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [HUMANWELL PURACAP PHARMACEUTICAL (WUHAN), LTD.]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8DOCUSATE SODIUM 100MG TWO-TONE (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [HUMANWELL PURACAP PHARMACEUTICAL (WUHAN), LTD.]1
GELATININACTIVE INGREDIENT2G86QN327LDOCUSATE SODIUM 100MG TWO-TONE (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [HUMANWELL PURACAP PHARMACEUTICAL (WUHAN), LTD.]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXDOCUSATE SODIUM 100MG TWO-TONE (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [HUMANWELL PURACAP PHARMACEUTICAL (WUHAN), LTD.]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ADOCUSATE SODIUM 100MG TWO-TONE (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [HUMANWELL PURACAP PHARMACEUTICAL (WUHAN), LTD.]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3DOCUSATE SODIUM 100MG TWO-TONE (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [HUMANWELL PURACAP PHARMACEUTICAL (WUHAN), LTD.]1
SORBITOLINACTIVE INGREDIENT506T60A25RDOCUSATE SODIUM 100MG TWO-TONE (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [HUMANWELL PURACAP PHARMACEUTICAL (WUHAN), LTD.]1
WATERINACTIVE INGREDIENT059QF0KO0RDOCUSATE SODIUM 100MG TWO-TONE (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [HUMANWELL PURACAP PHARMACEUTICAL (WUHAN), LTD.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53345-023DOCUSATE SODIUM 100MG TWO-TONE (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [HUMANWELL PURACAP PHARMACEUTICAL (WUHAN) CO., LTD.]5Current NDC, Legacy NDC, 2 package rows20241127_7cf1df18-d658-4bff-8a62-365fc5656942.zip
53345-023DOCUSATE SODIUM 100MG TWO-TONE (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [HUMANWELL PURACAP PHARMACEUTICAL (WUHAN), LTD.]3Current NDC, Legacy NDC, 2 package rows20241127_a923e5ca-86fd-4bf9-9931-180ddfdeae66.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 29 of 42 · 833 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Chocolated LaxativeSENNOSIDES STIMULANT LAXATIVEWalgreensc8ea170b-57b5-4643-ba88-4cf2ae1bf6a02024-12-23WarningsExact identifier
application number: M007
SennosidesSENNOSIDESMeijer, Inc.b09a234e-962d-49fc-a72e-898547b2f0992024-12-23WarningsExact identifier
application number: M007
Pedia-LaxGLYCERINC.B. Fleet Company, Inc.4e15f6ca-a40c-485f-be3f-07c2ed7cb4982024-12-23WarningsExact identifier
application number: M007
Chocolate Laxative Regular strength, Sennosides Stimulant Laxative, equateSENNOSIDESWal-Mart Stores Inc10dc8b4d-8136-44a5-a2ce-30295866cd3b2024-12-23WarningsExact identifier
application number: M007
Chocolated Laxative Regular Strength Sennosides Stimulant Laxative, Best ChoiceSENNOSIDESValu Merchandisers Company4b7cab4b-a610-4fb9-ac31-011975f1b29c2024-12-23WarningsExact identifier
application number: M007
Chocolated Laxative Regular Strength Sennosides Stimulant Laxative, DG healthSENNOSIDESDolgencorp Inc.88dc2f9b-18ca-4e21-8faa-5339f82a2a752024-12-23WarningsExact identifier
application number: M007
Chocolated Laxative Regular Strength Sennosides Stimulant Laxative TopCare healthSENNOSIDESTopco Associatesf051b302-f70e-4ab6-bb69-f69b45f2642e2024-12-23WarningsExact identifier
application number: M007
Chocolated LaxativeSENNOSIDES STIMULANT LAXATIVEC.D.M.A., Inc.e80be2b6-a0ca-4838-b956-a1debb065d572024-12-23WarningsExact identifier
application number: M007
ConlaxBISACODYLBliss GVS Pharma Limited7d25990b-6f7c-1eac-e053-2a91aa0a70222024-12-21WarningsExact identifier
application number: M007
GeriCare Docusate Sodium LiquidDOCUSATE SODIUMGERI-CARE PHARMACEUTICALS, CORPe50558e1-f0c8-4b03-9109-6a273b61730d2024-12-20WarningsExact identifier
application number: M007
SENNA SyrupSENNOSIDES A AND BSDA Laboratories, Inc.cfc6ab2f-5376-46fc-ac58-7dedd70100062024-12-20WarningsExact identifier
application number: M007
Fiber TherapyCALCIUM POLYCARBOPHILWal-Mart Stores, Inc.3432a4a6-aeb1-4a72-8451-5903266931fa2024-12-20WarningsExact identifier
application number: M007
Fiber LaxativeCALCIUM POLYCARBOPHILUNITED NATURAL FOODS, INC. DBA UNFIf7236bbc-8ded-4e11-8cce-b0a2255e14502024-12-20WarningsExact identifier
application number: M007
Fiber CapsCALCIUM POLYCARBOPHILGuardian Drug Company31e6b0c7-1d4a-4660-ae87-9d18e0001dcd2024-12-19WarningsExact identifier
application number: M007
Epsom SaltsMAGNESIUM SULFATENEW PRIDE CORPf6626023-4857-518b-e053-2a95a90a98212024-12-19WarningsExact identifier
application number: M007
MILK OF MAGNESIA CHERRYMAGNESIUM HYDROXIDEWALGREEN COMPANY5fae9b56-2555-b583-e053-2991aa0a8d592024-12-19WarningsExact identifier
application number: M007
MILK OF MAGNESIAMAGNESIUM HYDROXIDEWALGREEN COMPANY5faf2ed0-dd71-17c9-e053-2a91aa0ab75a2024-12-19WarningsExact identifier
application number: M007
Stimulant Laxative Plus Stool SoftenerDOCUSATE SODIUM 50 MG AND SENNOSIDES 8.6 MGRUGBY LABORATORIESf5afd8eb-d35d-44ab-897d-1d41c98ca1382024-12-19WarningsExact identifier
application number: M007
Goodsense FiberMETHYLCELLULOSEGoodSense96ed1ba1-7f91-4912-a549-a4be2c3e03622024-12-19WarningsExact identifier
application number: M007
Senexon-SDOCUSATE SODIUM 50MG AND SENNOSIDES 8.6MGRUGBY LABORATORIES2e758ff1-3083-4245-8f58-1c47b042bfdd2024-12-19WarningsExact identifier
application number: M007

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1115005docusate sodium 100 MG Oral CapsulePSN7cf1df18-d658-4bff-8a62-365fc56569425
1115005docusate sodium 100 MG Oral CapsuleSCD7cf1df18-d658-4bff-8a62-365fc56569425
1115005DOSS Sodium 100 MG Oral CapsuleSY7cf1df18-d658-4bff-8a62-365fc56569425
1115005docusate sodium 100 MG Oral CapsulePSNa923e5ca-86fd-4bf9-9931-180ddfdeae663
1115005docusate sodium 100 MG Oral CapsuleSCDa923e5ca-86fd-4bf9-9931-180ddfdeae663
1115005DOSS Sodium 100 MG Oral CapsuleSYa923e5ca-86fd-4bf9-9931-180ddfdeae663

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53345-023-01533450023011 BAG in 1 BOX (53345-023-01) / 20000 CAPSULE, LIQUID FILLED in 1 BAG1 bag2014-08-110000-00-00NoNoCurrent
53345-023-02533450023021 BAG in 1 BOX (53345-023-02) / 15000 CAPSULE, LIQUID FILLED in 1 BAG1 bag2015-04-100000-00-00NoNoCurrent