FDA.reportPublic FDA data

Stool Softener

Product NDC
72476-878
11-digit product format
724760878
Labeler code
72476
Product ID
72476-878_e23db7b7-909e-4019-bb58-3a8aa5465cf0
Type
HUMAN OTC DRUG
Nonproprietary name
docusate sodium and sennosides
Dosage form
TABLET
Route
ORAL
Labeler
Care One (Retail Business Services, LLC.)
Application
M007
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-06-30
Substance
DOCUSATE SODIUM; SENNOSIDES
Active strength
50; 8.6 mg/1; 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
Brand name suffix
Plus Stimulant Laxative
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DOCUSATE SODIUM50 mg/1
SENNOSIDES8.6 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
F05Q2T2JA0Internal UNII lookup
3FYP5M0IJXInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
998740Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
9adaec97-43e3-48f2-96c8-c508b693676cAvailable on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
72476-878-102023-10-05C16284748780-1f386c649-cf1b-0266-e053-dadaa90a7c1aDrug Facts
72476-878-102023-01-30C16284748780-1f386c649-cf1b-0266-e053-dadaa90a7c1aDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72476-878-10Stool SoftenerPlus Stimulant Laxative100 in 1 BOTTLE, PLASTICTABLET1002
72476-878-10Stool SoftenerPlus Stimulant Laxative1 in 1 BOXTABLET12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72476-878STOOL SOFTENER PLUS STIMULANT LAXATIVE (DOCUSATE SODIUM AND SENNOSIDES) TABLET [CARE ONE (RETAIL BUSINESS SERVICES, LLC.)]2Current NDC, Legacy NDC, 2 package rows20231006_9adaec97-43e3-48f2-96c8-c508b693676c.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 32 of 42 · 833 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
NuValu Epsom SaltMAGNESIUM SULFATE (HEPTAHYDRATE)J C SALES5a503d8d-7899-4b1e-be6f-8e2a759af2652024-12-04WarningsExact identifier
application number: M007
SENNOSIDESSENNOSIDESCVS Pharmacy, Inc.6dffc3f5-bae0-c436-e053-2991aa0a0f8b2024-12-02WarningsExact identifier
application number: M007
Pure and GentleMINERAL OILMedline Industries, LP96d4cad5-0602-4c31-94ed-3117b4fd4a942024-11-26WarningsExact identifier
application number: M007
Pure and Gentle LaxativeSODIUM PHOSPHATEMedline Industries, LPe3165538-75dd-4f0f-adc8-d4075de10f1e2024-11-26WarningsExact identifier
application number: M007
DOCUSATE SODIUM 50 MGDOCUSATE SODIUMHumanwell PuraCap Pharmaceutical (Wuhan), Ltd.af7533e6-8b06-48a4-940e-7ecb57b24b592024-11-25WarningsExact identifier
application number: M007
DOCUSATE SODIUM 100mg Two-ToneDOCUSATE SODIUMHumanwell PuraCap Pharmaceutical (Wuhan), Ltd.a923e5ca-86fd-4bf9-9931-180ddfdeae662024-11-25WarningsExact identifier
application number: M007
DOCUSATE SODIUM 100mg Two-ToneDOCUSATE SODIUMHumanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd.7cf1df18-d658-4bff-8a62-365fc56569422024-11-25WarningsExact identifier
application number: M007
DOCUSATE SODIUM 100mgDOCUSATE SODIUMHumanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd.c5bdfbfc-d24a-4088-9b60-ecea8120ff432024-11-25WarningsExact identifier
application number: M007
DOCUSATE SODIUMDOCUSATE SODIUMHumanwell PuraCap Pharmaceutical (Wuhan), Ltd.b10fdf50-289e-41f3-9b83-a4e4dd892f882024-11-21WarningsExact identifier
application number: M007
DOCUSATE SODIUM 100mg Two-ToneDOCUSATE SODIUMHumanwell PuraCap Pharmaceutical (Wuhan), Ltd.85c64624-428d-46fa-8071-f42b8feec0492024-11-21WarningsExact identifier
application number: M007
Docusate SodiumDOCUSATE SODIUMHumanwell PuraCap Pharmaceuticals (Wuhan) Co., Ltd33251cb7-b7b1-4f6c-9e10-4fa64cbf03a02024-11-21WarningsExact identifier
application number: M007
STOOL SOFTENERDOCUSATE SODIUMWalgreen Co.d8d97ca5-5131-4620-8ce9-bc3f9d5c0ab52024-11-21WarningsExact identifier
application number: M007
4718 Enema, Mineral Oil4718 ENEMA, MINERAL OILDynarex9e51c852-9477-5cf5-e053-2a95a90a97db2024-11-20WarningsExact identifier
application number: M007
ReliefSODIUM PHOSPHATE, MONOBASIC AND SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATELeosons Overseas Corp5b301d5b-1e2c-47ed-a05f-d6be0fdfc9402024-11-19WarningsExact identifier
application number: M007
REFLIEF SALINE LAXATIVE PEDIATRIC READY TO USESODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM AND SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORMLeosons Overseas Corp90e7c2b4-35e1-4a27-afea-9257c480e1902024-11-19WarningsExact identifier
application number: M007
Stool SoftenerDOCUSATE SODIUM 100MGPuraCap Pharmaceutical LLC272c86f1-f229-2ebf-e063-6394a90a34712024-11-18WarningsExact identifier
application number: M007
Milk of Magnesia ConcentrateMAGNESIUM HYDROXIDEPAI Holdings, LLC dba PAI Pharma2a99a1a8-a830-429f-9cfd-3f29c3d3547c2024-11-12WarningsExact identifier
application number: M007
Docusate SodiumDOCUSATE SODIUMA-S Medication Solutions122486e9-74dd-4181-97d1-0b07688280f42024-11-06WarningsExact identifier
application number: M007
Stratuscare Adult GlycerinGLYCERINStratus Pharmaceuticals3e1935da-5c1f-4942-98dd-320fade823212024-11-04WarningsExact identifier
application number: M007
DOCUSATE SODIUMDOCUSATE SODIUMNuCare Pharmaceuticals,Inc.fdf3c8e1-d554-4cdb-e053-6394a90a542e2024-11-01WarningsExact identifier
application number: M007

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
998740sennosides 8.6 MG / docusate sodium 50 MG Oral TabletPSN9adaec97-43e3-48f2-96c8-c508b693676c2
998740docusate sodium 50 MG / sennosides, USP 8.6 MG Oral TabletSCD9adaec97-43e3-48f2-96c8-c508b693676c2
998740DOSS Sodium 50 MG / sennosides, USP 8.6 MG Oral TabletSY9adaec97-43e3-48f2-96c8-c508b693676c2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
72476-878-10724760878101 BOTTLE, PLASTIC in 1 BOX (72476-878-10) / 100 TABLET in 1 BOTTLE, PLASTIC2020-06-300000-00-00NoNoCurrent