FDA.reportPublic FDA data

DOCUSATE SODIUM 100mg Two-Tone

Product NDC
53345-018
11-digit product format
533450018
Labeler code
53345
Product ID
53345-018_2767f5d0-11e2-5dbb-e063-6394a90a364c
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
2013-12-23
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
85c64624-428d-46fa-8071-f42b8feec049Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53345-018-01DOCUSATE SODIUM 100mg Two-Tone1 in 1 BOXCAPSULE, LIQUID FILLED15
53345-018-01DOCUSATE SODIUM 100mg Two-Tone20000 in 1 BAGCAPSULE, LIQUID FILLED200005
53345-018-02DOCUSATE SODIUM 100mg Two-Tone15000 in 1 BAGCAPSULE, LIQUID FILLED150005
53345-018-02DOCUSATE SODIUM 100mg Two-Tone1 in 1 BOXCAPSULE, LIQUID FILLED15

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), LTD.]2
DOCUSATEACTIVE MOIETYM7P27195AGDOCUSATE SODIUM 100MG TWO-TONE (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [HUMANWELL PURACAP PHARMACEUTICAL (WUHAN), LTD.]2
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLDOCUSATE SODIUM 100MG TWO-TONE (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [HUMANWELL PURACAP PHARMACEUTICAL (WUHAN), LTD.]2
D&C RED NO. 33INACTIVE INGREDIENT9DBA0SBB0LDOCUSATE SODIUM 100MG TWO-TONE (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [HUMANWELL PURACAP PHARMACEUTICAL (WUHAN), LTD.]2
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDDOCUSATE SODIUM 100MG TWO-TONE (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [HUMANWELL PURACAP PHARMACEUTICAL (WUHAN), LTD.]2
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOADOCUSATE SODIUM 100MG TWO-TONE (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [HUMANWELL PURACAP PHARMACEUTICAL (WUHAN), LTD.]2
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8DOCUSATE SODIUM 100MG TWO-TONE (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [HUMANWELL PURACAP PHARMACEUTICAL (WUHAN), LTD.]2
GELATININACTIVE INGREDIENT2G86QN327LDOCUSATE SODIUM 100MG TWO-TONE (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [HUMANWELL PURACAP PHARMACEUTICAL (WUHAN), LTD.]2
GLYCERININACTIVE INGREDIENTPDC6A3C0OXDOCUSATE SODIUM 100MG TWO-TONE (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [HUMANWELL PURACAP PHARMACEUTICAL (WUHAN), LTD.]2
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ADOCUSATE SODIUM 100MG TWO-TONE (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [HUMANWELL PURACAP PHARMACEUTICAL (WUHAN), LTD.]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3DOCUSATE SODIUM 100MG TWO-TONE (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [HUMANWELL PURACAP PHARMACEUTICAL (WUHAN), LTD.]2
SORBITOLINACTIVE INGREDIENT506T60A25RDOCUSATE SODIUM 100MG TWO-TONE (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [HUMANWELL PURACAP PHARMACEUTICAL (WUHAN), LTD.]2
WATERINACTIVE INGREDIENT059QF0KO0RDOCUSATE SODIUM 100MG TWO-TONE (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [HUMANWELL PURACAP PHARMACEUTICAL (WUHAN), LTD.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53345-018DOCUSATE SODIUM 100MG TWO-TONE (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [HUMANWELL PURACAP PHARMACEUTICAL (WUHAN), LTD.]5Current NDC, Legacy NDC, 4 package rows20241122_85c64624-428d-46fa-8071-f42b8feec049.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 CapsulePSN85c64624-428d-46fa-8071-f42b8feec0495
1115005docusate sodium 100 MG Oral CapsuleSCD85c64624-428d-46fa-8071-f42b8feec0495
1115005DOSS Sodium 100 MG Oral CapsuleSY85c64624-428d-46fa-8071-f42b8feec0495

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53345-018-01533450018011 BAG in 1 BOX (53345-018-01) / 20000 CAPSULE, LIQUID FILLED in 1 BAG1 bag2013-12-230000-00-00NoNoCurrent
53345-018-02533450018021 BAG in 1 BOX (53345-018-02) / 15000 CAPSULE, LIQUID FILLED in 1 BAG1 bag2013-12-230000-00-00NoNoCurrent