FDA.reportPublic FDA data

MiraSOFT Stool Softener

Product NDC
11523-8259
11-digit product format
115238259
Labeler code
11523
Product ID
11523-8259_5d42a9ca-d9dc-02e7-e063-6294a90a446f
Type
HUMAN OTC DRUG
Nonproprietary name
docusate sodium
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
Bayer HealthCare LLC.
Application
M007
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2026-08-03
Substance
DOCUSATE SODIUM
Active strength
100 mg/1
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
MiraSOFT Stool Softener
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DOCUSATE SODIUM100 mg/1

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 38 of 42 · 833 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Stool Softener LaxativeDOCUSATE SODIUMCare One (Retail Business Services, LLC.)eb7f3d65-8741-407d-b3f3-1d9dda19684d2024-03-05WarningsExact identifier
application number: M007
FleetSODIUM PHOSPHATE, DIBASIC AND SODIUM PHOSPHATE, MONOBASICC.B. Fleet Company, Inc.f50ba829-16c3-40a7-9822-8d6d00353b332024-02-29WarningsExact identifier
application number: M007
Stool Softener LaxativeDOCUSATE SODIUMBJWC (Berkley & Jensen / BJ's)4ce62421-97e0-4920-9a6d-9fa1f0f93fe42024-02-23WarningsExact identifier
application number: M007
Stool SoftenerDOCUSATE SODIUMBryant Ranch Prepack851a5dda-e72b-4067-a98f-54d3222f646e2024-02-23WarningsExact identifier
application number: M007
Stool Softener LaxativeDOCUSATE SODIUMBJWC (Berkley & Jensen / BJ's)2ca80e23-f38a-4f77-b536-131cc9f0cf5b2024-02-23WarningsExact identifier
application number: M007
Colon DetoxDOCUSATE SODIUM AND SENNOSIDESOPMX LLC0a4d3265-080c-d2ed-e063-6394a90adbee2024-02-21WarningsExact identifier
application number: M007
Stool Softener LaxativeDOCUSATE SODIUM AND SENNOSIDESBest Choice (Valu Merchandisers Company)4501d718-15a7-4e27-bdb1-8aa2d3ff06d02024-02-20WarningsExact identifier
application number: M007
Stool Softener LaxativeDOCUSATE SODIUMBest Choice (Valu Merchandisers Company)72bd251b-4e82-41ef-8362-39f95faf99162024-02-15WarningsExact identifier
application number: M007
Magnesium CitrateLEADER MAGNESIUM CITRATE ORAL SOLUTION - LEMONCARDINAL HEALTH, INC. 06399736010bdd5e6-3db2-8f9e-e063-6394a90a9b3f2024-02-06WarningsExact identifier
application number: M007
Magnesium CitrateLEADER MAGNESIUM CITRATE ORAL SOLUTION - GRAPECARDINAL HEALTH, INC. 06399736010beb3ec-a189-221d-e063-6394a90aabb52024-02-06WarningsExact identifier
application number: M007
Magnesium CitrateLEADER MAGNESIUM CITRATE ORAL SOLUTION - CHERRYCARDINAL HEALTH, INC. 06399736010bebb63-19b3-2e14-e063-6394a90a8d4e2024-02-06WarningsExact identifier
application number: M007
Docusate SodiumDOCUSATE SODIUMProficient Rx LPf9ac0344-5864-4ac1-81bc-16878a5946c52024-02-01WarningsExact identifier
application number: M007
Purifi Hand SanitizerBENZALKONIUM CHLORIDEPurifi LLC9267069d-4cf5-4e48-a446-7dbebea16bf52024-01-31WarningsExact identifier
application number: M007
WOMENS LAXATIVE ENTERIC COATEDBISACODYLCARDINAL HEALTHab34bc89-6738-d284-e053-2a95a90a5dc92024-01-11WarningsExact identifier
application number: M007
MAXIMUM STRENGTH LAXATIVESENNOSIDESCARDINAL HEALTHb7b13bfa-8a94-6f62-e053-2995a90abbf42024-01-10WarningsExact identifier
application number: M007
FIBER LAXATIVECALCIUM POLYCARBOPHILMagno-Humphries, Inc.e4a921c5-1cf7-12ca-e053-2a95a90a6e042024-01-03WarningsExact identifier
application number: M007
Freskaro Castor OilCASTOR OILPharma Nobis, LLCfbd6bdd5-a7a1-3f28-e053-6294a90aab872023-12-28WarningsExact identifier
application number: M007
Humco Castor OilCASTOR OILPharma Nobis, LLCe42f9d37-1b07-177a-e053-2a95a90a9b062023-12-26WarningsExact identifier
application number: M007
Magnesium CitrateFRESKARO MAGNESIUM CITRATE ORAL SOLUTION - LEMONPharma Nobis, LLCf0477328-eca1-9043-e053-2995a90aaa3d2023-12-22WarningsExact identifier
application number: M007
Magnesium CitrateFRESKARO MAGNESIUM CITRATE ORAL SOLUTION - CHERRYPharma Nobis, LLCf0489f6f-9e60-7d69-e053-2a95a90a9dfb2023-12-22WarningsExact identifier
application number: M007

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
11523-8259-3115238259031 BOTTLE, PLASTIC in 1 CARTON (11523-8259-3) / 30 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC2026-08-03NoNoCurrent
11523-8259-6115238259061 BOTTLE, PLASTIC in 1 CARTON (11523-8259-6) / 60 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC2026-08-03NoNoCurrent