FDA.reportPublic FDA data

STOOL SOFTENER

Product NDC
57896-421
11-digit product format
578960421
Labeler code
57896
Product ID
57896-421_548956c0-c6c7-be65-e063-6294a90a44fe
Type
HUMAN OTC DRUG
Nonproprietary name
docusate sodium
Dosage form
TABLET
Route
ORAL
Labeler
Geri-Care Pharmaceuticals, Corp
Application
M007
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2015-09-01
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
STOOL SOFTENER
Listing expiration
2027-12-31

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
1099279Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
3ec42148-6786-22f2-e054-00144ff8d46cAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57896-421-01STOOL SOFTENER100 in 1 BOTTLETABLET1005
57896-421-10STOOL SOFTENER1000 in 1 BOTTLETABLET10005
57896-421-20STOOL SOFTENER200 in 1 BOTTLETABLET2005

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
57896-421-01EA - Each57896-42181c968a7-8921-4237-8518-0aea0336f8ed12016-11-08
57896-421-10EA - Each57896-4213f2e704c-f32c-409c-b2b9-3587365c5f1d12016-11-08
57896-421-20EA - Each57896-421f0110dec-7b8d-45b9-a166-56a71b6ddde212022-03-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57896-421STOOL SOFTENER (DOCUSATE SODIUM) TABLET [GERI-CARE PHARMACEUTICALS, CORP]5Current NDC, Legacy NDC, 3 package rows20241218_3ec42148-6786-22f2-e054-00144ff8d46c.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 33 of 43 · 858 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
milk of magnesiaMAGNESIUM HYDROXIDECVS Pharmacyb3a36251-edd6-4201-8da1-85d7a6ede1732024-12-05WarningsExact identifier
application number: M007
CITRUCELMETHYLCELLULOSEHaleon US Holdings LLCd27f6742-2dcc-451e-b803-6ffe183038ec2024-12-05WarningsExact identifier
application number: M007
LaxacinDOCUSATE SODIUM AND SENNOSIDESAlexso, Inc0df9abaf-3997-4dde-8003-ae3d8d07cf392024-12-04WarningsExact identifier
application number: M007
NuValu Epsom SaltMAGNESIUM SULFATE (HEPTAHYDRATE)J C SALES9f3cf9a4-e5c0-41ff-9fd3-63efb0d973cd2024-12-04WarningsExact identifier
application number: M007
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1099279docusate sodium 100 MG Oral TabletPSN3ec42148-6786-22f2-e054-00144ff8d46c5
1099279docusate sodium 100 MG Oral TabletSCD3ec42148-6786-22f2-e054-00144ff8d46c5
1099279DOSS Sodium 100 MG Oral TabletSY3ec42148-6786-22f2-e054-00144ff8d46c5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
57896-421-0157896042101100 TABLET in 1 BOTTLE (57896-421-01) 100 tablet2015-09-010000-00-00NoNoCurrent
57896-421-10578960421101000 TABLET in 1 BOTTLE (57896-421-10) 1000 tablet2015-09-010000-00-00NoNoCurrent
57896-421-2057896042120200 TABLET in 1 BOTTLE (57896-421-20) 200 tablet2019-05-010000-00-00NoNoCurrent