FDA.reportPublic FDA data

Curewell Docusate Sodium Liquid

Product NDC
85111-403
11-digit product format
851110403
Labeler code
85111
Product ID
85111-403_55901be3-f1c3-f683-e063-6394a90a25fe
Type
HUMAN OTC DRUG
Nonproprietary name
Docusate Sodium.50mg/5mL
Dosage form
SOLUTION
Route
ORAL
Labeler
RMT HEALTH LLC
Application
M007
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2026-07-01
Substance
DOCUSATE SODIUM
Active strength
50 mg/5mL
NDC exclude flag
No
Listing certified through
2027-12-31
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
Curewell Docusate Sodium Liquid
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DOCUSATE SODIUM50 mg/5mL

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
1245686Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
55903043-2a1d-0525-e063-6394a90ae182Available on FDA.report

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 18 of 42 · 833 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PHILLIPS FRESH MINT MILK OF MAGNESIAPHILLIPS FRESH MINT MILK OF MAGNESIABayer HealthCare LLC.0a59f9c3-c14e-2824-e054-00144ff8d46c2025-12-04WarningsExact identifier
application number: M007
CVS Mini EnemaDOCUSATE SODIUM W/BENZOCAINECVS HEALTHca00c520-410a-1905-e053-2995a90a56f02025-12-04WarningsExact identifier
application number: M007
Docusate Mini EnemaDOCUSATE SODIUMMajor Pharmaceuticals91099e15-94d7-b684-e053-2a95a90a574e2025-12-04WarningsExact identifier
application number: M007
Stool SoftenerDOCUSATE SODIUMGeri-Care Pharmaceutical Corp1057c0bf-4bf6-ea17-e063-6294a90a59842025-12-04WarningsExact identifier
application number: M007
PHILLIPS ORIGINAL MILK OF MAGNESIAPHILLIPS ORIGINAL MILK OF MAGNESIABayer HealthCare LLC.0a57bb45-d4f7-443b-e054-00144ff8d46c2025-12-04WarningsExact identifier
application number: M007
Equalactin LaxativeCALCIUM POLYCARBOPHILNUMARK BRANDS, INC2feed33a-3b7f-11c6-6e62-c99150ecfddd2025-12-03WarningsExact identifier
application number: M007
Gentle Laxative Stimulant LaxativeBISACODYLQUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)bcd3c07d-bd83-4452-9736-35c85db30c152025-12-03WarningsExact identifier
application number: M007
Quality Choice Fiber LaxativePSYLLIUM HUSKQUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)2ee637c4-c4c6-4a24-ae99-612205afd5922025-12-03WarningsExact identifier
application number: M007
Quality ChoiceCALCIUM POLYCARBOPHILQUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)f1e69c65-c1b0-459f-9a12-b1a92b90036b2025-12-03WarningsExact identifier
application number: M007
CDMA Fiber TherapyMETHYLCELLULOSECHAIN DRUG MARKETING ASSOCIATION62bbcaf2-1d0c-485f-9159-685700aa34182025-12-03WarningsExact identifier
application number: M007
Stool SoftenerDOCUSATE SODIUMReliable 1 Laboratories LLC44fae161-3fc8-64c4-e063-6294a90a1d262025-12-02WarningsExact identifier
application number: M007
Stool SoftenerDOCUSATE SODIUMRMT HEALTH LLC44fbb197-fe90-c5a8-e063-6394a90adb7d2025-12-02WarningsExact identifier
application number: M007
Fiber LaxCALCIUM POLYCARBOPHILRugby Laboratories318d81ed-0b06-4d21-8b97-2d1f0267c7812025-12-02WarningsExact identifier
application number: M007
Magnesium CitrateEPIC MEDICAL MAGNESIUM CITRATE ORAL SOLUTION - LEMON4 Visions LLC44fe65d0-ee46-1d95-e063-6294a90abb712025-12-02WarningsExact identifier
application number: M007
FIBER TABSCALCIUM POLYCARBOPHILMajor Pharmaceuticalsbee100da-b9c9-4261-b6e6-7b3db57156252025-12-02WarningsExact identifier
application number: M007
Quality Choice Stool SoftenerDOCUSATE SODIUMChain Drug Marketing Associationb1440ab7-a7d5-4153-8143-cffad73120f52025-12-02WarningsExact identifier
application number: M007
Walgreen Fiber LaxCALCIUM POLYCARBOPHILWALGREENS CO.9cbe1798-e0dc-4a90-bd91-8696fc59b2a62025-11-25WarningsExact identifier
application number: M007
Walgreens Fiber TherapyMETHYLCELLULOSEWALGREENS CO.6401a2c3-5869-4898-81db-3cd7151ca69a2025-11-25WarningsExact identifier
application number: M007
Walgreens Senna LaxativeSENNOSIDESWALGREENS CO.a95bd796-d85e-4599-bbb1-2170088fa9372025-11-25WarningsExact identifier
application number: M007
Walgreens Stool Softener Fruit PunchDOCUSATE SODIUMWALGREENS CO.8428c81d-227a-4b0f-9a47-71d6a69838422025-11-25WarningsExact identifier
application number: M007

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85111-403-16851110403161 BOTTLE in 1 BOX (85111-403-16) / 473 mL in 1 BOTTLE1 bottle2026-07-01NoNoCurrent