FDA.reportPublic FDA data

Stool Softener

Product NDC
68071-5297
11-digit product format
680715297
Labeler code
68071
Product ID
68071-5297_53728778-9acd-ab94-e063-6294a90a47ec
Type
HUMAN OTC DRUG
Nonproprietary name
DOCUSATE SODIUM
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
NuCare Pharmaceuticals, Inc.
Application
M007
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-04-01
Substance
DOCUSATE SODIUM
Active strength
250 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
Stool Softener
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DOCUSATE SODIUM250 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
1245468Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
53727f3a-914c-0e2c-e063-6394a90a3886Available 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 25 of 42 · 829 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Mineral OilMINERAL OILAmerisourceBergen (Good Neighbor Pharmacy) 46122581f81a0-7488-4c90-b33e-06c6301a4fd22025-04-17WarningsExact identifier
application number: M007
Vegetable LaxativeSENNOSIDESWalmart Inc.26dc60e7-5a05-64c3-e063-6394a90a55ce2025-04-14WarningsExact identifier
application number: M007
Epsom SaltMAGNESIUM SULFATEStrategic Sourcing Services LLC99aa30ed-9659-4f60-a31d-6aaf09909b512025-04-14WarningsExact identifier
application number: M007
Fiber LaxativeCALCIUM POLYCARBOPHILGeri-Care Pharmaceutical Corp616b4399-7626-5e59-e053-2a91aa0a0f752025-04-07WarningsExact identifier
application number: M007
Calcium PolycarbophilCALCIUM POLYCARBOPHILCITRAGEN PHARMACEUTICALS, INC.b23dd90f-ba5a-80fc-e053-2995a90a22862025-04-03WarningsExact identifier
application number: M007
Phillips Milk Of Magnesia Wild CherryPHILLIPS MILK OF MAGNESIA WILD CHERRYBayer HealthCare LLC.0a6d824a-3d9a-07f9-e054-00144ff8d46c2025-04-01WarningsExact identifier
application number: M007
Epsom SaltMAGNESIUM SULFATECVS PHARMACY30ce5cbd-cc7a-0b2d-e063-6394a90a85202025-03-20WarningsExact identifier
application number: M007
SennaSENNOSIDESAARNA USA INC.7ad21fb7-20eb-48d6-be15-450aa2ec97d32025-03-20WarningsExact identifier
application number: M007
CVS Health Stool Softener Plus stimulant laxative SoftgelDOCUSATE SODIUM, SENNOSIDESCVS Pharmacy, Inc2881d83d-9929-677a-e063-6394a90a04242025-03-19WarningsExact identifier
application number: M007
Mineral OilMINERAL OILKesin Pharma Corporation30a11cc9-e407-23b7-e063-6294a90a7d6e2025-03-18WarningsExact identifier
application number: M007
CVS Magnesium Hydroxide Laxative ChewMAGNESIUM HYDROXIDECVS30126c74-6f5c-72f3-e063-6394a90ad81f2025-03-11WarningsExact identifier
application number: M007
Epsom SaltEPSOM SALTGood Sense (Geiss, Destin & Dunn, Inc.)c7a9f180-9c73-4317-adbe-f95702fb48022025-03-03WarningsExact identifier
application number: M007
Magnesium Citrate Saline LaxativeMAGNESIUM CITRATEAARNA USA INC.e7550220-df26-4a7a-a254-bebb225d9e5e2025-03-01WarningsExact identifier
application number: M007
Fiber laxativeCALCIUM POLYCARBOPHILDiscount Drug Mart, Inc2e0c4736-3d27-e088-e063-6294a90aeca82025-02-27WarningsExact identifier
application number: M007
Mineral oilMINERAL OILP & L Development, LLC68e88119-1468-4ab7-a5fa-242d960d25df2025-02-21WarningsExact identifier
application number: M007
Epsom SaltMAGNESIUM SULFATEWhole Foods Market5a88048e-5417-4d8e-a149-f51610a5d4202025-02-19WarningsExact identifier
application number: M007
SennosidesSENNOSIDESPD-Rx Pharmaceuticals, Inc.829d24b7-a46a-4a29-88fe-180f35a2b6cd2025-02-18WarningsExact identifier
application number: M007
Stool Softener and Stimulant LaxativeDOCUSATE SODIUM, SENNOSIDESH-E-Bc19280c2-f968-b582-e053-2995a90a9bd32025-02-14WarningsExact identifier
application number: M007
STOOL SOFTENER-STIMULANT LAXATIVESTOOL SOFTENER-STIMULANT LAXATIVEKroger Companya22c9f95-e3a9-bfd3-e053-2995a90a3c662025-02-13WarningsExact identifier
application number: M007
Womens Gentle LaxativeBISACODYLBETTER LIVING BRANDS LLC.f2c4ed1a-5aa4-1915-e053-2a95a90a59b62025-02-12WarningsExact identifier
application number: M007

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
68071-5297-66807152970660 CAPSULE, LIQUID FILLED in 1 BOTTLE (68071-5297-6) 2026-06-04NoNoCurrent