Stool Softener Laxative

Product NDC
37808-878
11-digit product format
378080878
Labeler code
37808
Product ID
37808-878_5f57d4e9-b3d5-497f-9e11-43e244acea11
Type
HUMAN OTC DRUG
Nonproprietary name
docusate sodium and sennosides
Dosage form
TABLET
Route
ORAL
Labeler
H E B
Application
M007
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-06-03
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 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
2f9e2723-53a7-47a8-8c41-87bffc4e50ddAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
37808-878-12Stool Softener Laxative120 in 1 BOTTLE, PLASTICTABLET1203
37808-878-24Stool Softener Laxative240 in 1 BOTTLE, PLASTICTABLET2403

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
37808-878STOOL SOFTENER LAXATIVE (DOCUSATE SODIUM AND SENNOSIDES) TABLET [H E B]3Current NDC, Legacy NDC, 2 package rows20240410_2f9e2723-53a7-47a8-8c41-87bffc4e50dd.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 31 of 42 · 833 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Rite Aid Stool SoftenerDOCUSATE CALCIUMRite Aid281b2bc7-4980-4205-a33f-cb1974af8d062024-12-18WarningsExact identifier
application number: M007
Topcare Stool SoftenerDOCUSATE SODIUMTOPCO ASSOCIATES LLC93158bd3-c830-4b12-ab1c-133a4bdb9c782024-12-18WarningsExact identifier
application number: M007
HEB Stool SoftenerDOCUSATE SODIUMH E Bafc54b8e-03d9-418c-9322-97d68f9290312024-12-18WarningsExact identifier
application number: M007
Foster and Thrive Gentle LaxativeBISACODYLStrategic Sourcing Services LLCd03c2c42-d9d9-4b4b-a6ae-31d99425a2282024-12-18WarningsExact identifier
application number: M007
EX-LAX REGULAR STRENGTH CHOCOLATED STIMULANT LAXATIVESENNOSIDESHaleon US Holdings LLC59a26a7f-516f-4507-8dec-f40cf6cfaffc2024-12-17WarningsExact identifier
application number: M007
EX-LAX MAXIMUM STRENGTH STIMULANT LAXATIVESENNOSIDESHaleon US Holdings LLCfb170340-c996-46cf-b165-84e136ba41512024-12-17WarningsExact identifier
application number: M007
Senna SyrupNATURAL VEGETABLE LAXATIVEBryant Ranch Prepack7d1f092e-0e5b-4fed-a095-64449751582d2024-12-16WarningsExact identifier
application number: M007
Drug Mart Vegetable Laxative plus Stool SoftenerDOCUSATE SODIUM, SENNOSIDESDiscount Drug Mart, Inc1b6d59e8-112f-447f-b6e9-526b7d3bd01e2024-12-13WarningsExact identifier
application number: M007
Drug Mart Stool Softener plus Stimulant LaxativeDOCUSATE SODIUM, SENNOSIDESDiscount Drug Mart, Inccaf74258-922c-4b69-9bd6-57b3e918c7a62024-12-13WarningsExact identifier
application number: M007
Docusate SodiumDOCUSATE SODIUMNational Vitamin Company0c66642c-82cb-42cd-82bb-5f95852cc5d12024-12-12WarningsExact identifier
application number: M007
Foster and Thrive Fiber Laxative 147CALCIUM POLYCARBOPHILStrategic Sourcing Services LLC88d341a6-28aa-4a20-bfed-1d5f3106c2ae2024-12-12WarningsExact identifier
application number: M007
Pedia-LaxSODIUM PHOSPHATE, DIBASIC AND SODIUM PHOSPHATE, MONOBASICC.B. Fleet Company, Inc.f001a37d-8ed4-428b-af12-d6a83c22c1272024-12-12WarningsExact identifier
application number: M007
Careone Milk of magnesia Original Milk of Magnesia OriginalMAGNESIUM HYDROXIDERetail Business Services, LLC.13ffb00b-7c6f-47aa-bc82-2402d121a7582024-12-11WarningsExact identifier
application number: M007
CareOne Milk of Magnesia CherryMAGNESIUM HYDROXIDERetail Business Services, LLC.1822f90d-f693-48d7-b338-a3f2ddfac4df2024-12-11WarningsExact identifier
application number: M007
MILK OF MAGNESIA MINTMAGNESIUM HYDROXIDEGOOD SENSEa951b6d0-9182-e1bc-e053-2a95a90a12b12024-12-09WarningsExact identifier
application number: M007
SennosidesSENNOSIDESMajor Pharmaceuticalsdf3b431b-a1ad-91dd-e053-2995a90aa02f2024-12-06WarningsExact identifier
application number: M007
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
998740sennosides 8.6 MG / docusate sodium 50 MG Oral TabletPSN2f9e2723-53a7-47a8-8c41-87bffc4e50dd3
998740docusate sodium 50 MG / sennosides, USP 8.6 MG Oral TabletSCD2f9e2723-53a7-47a8-8c41-87bffc4e50dd3
998740DOSS Sodium 50 MG / sennosides, USP 8.6 MG Oral TabletSY2f9e2723-53a7-47a8-8c41-87bffc4e50dd3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
37808-878-1237808087812120 TABLET in 1 BOTTLE, PLASTIC (37808-878-12) 120 tablet2021-06-030000-00-00NoNoCurrent
37808-878-2437808087824240 TABLET in 1 BOTTLE, PLASTIC (37808-878-24) 240 tablet2021-06-030000-00-00NoNoCurrent