Stool Softener Laxative

Product NDC
37808-853
11-digit product format
378080853
Labeler code
37808
Product ID
37808-853_4e267840-1b97-4a79-a1cf-29a6a9aa9151
Type
HUMAN OTC DRUG
Nonproprietary name
DOCUSATE SODIUM
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
H E B
Application
M007
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-10-29
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 Laxative
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
1115005Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
84116db2-a7b7-460a-a5e5-8558bd424781Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
37808-853-30Stool Softener Laxative300 in 1 BOTTLE, PLASTICCAPSULE, LIQUID FILLED3005

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
37808-853STOOL SOFTENER LAXATIVE (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [H E B]4Current NDC, Legacy NDC, 1 package rows20240410_84116db2-a7b7-460a-a5e5-8558bd424781.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 12 of 42 · 833 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Well at Walgreens Castor OilCASTOR OILWalgreen Co.e41f8553-3812-4d0b-95f8-20b2612792992026-02-12Warnings, Adverse reactionsExact identifier
application number: M007
Epsom SaltMAGNESIUM SULFATEWalgreen Co.b5a02809-6e01-4e01-b1c3-2b10c5091a4e2026-02-12Warnings, Adverse reactionsExact identifier
application number: M007
Mineral OilMINERAL OILWalgreen Co.822fd02a-92b0-4010-8bfb-737dba331d542026-02-12Warnings, Adverse reactionsExact identifier
application number: M007
MILK OF MAGNESIA MINTMAGNESIUM HYDROXIDERugby Laboratories5fd89979-903e-4b31-872d-3b8974af3a6b2026-02-09WarningsExact identifier
application number: M007
Epsom SaltEPSOM SALTEQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)1845ea0c-0cb6-482b-abe6-fa17785c5b902026-02-09WarningsExact identifier
application number: M007
Colace Fast-Acting Saline LaxativeMAGNESIUM HYDROXIDEAtlantis Consumer Healthcare, Inc.572adfaf-6e26-42e5-b65d-6d356a0bdfa92026-02-06WarningsExact identifier
application number: M007
Castor OilCASTOR OILRetail Business Services, LLC4e9c41fa-f240-4986-bb13-541bfeb0e50b2026-02-06WarningsExact identifier
application number: M007
citromaMAGNESIUM CITRATERetail Business Services, LLCf3661952-ef4f-4f29-93e6-ec09b84643652026-02-06Warnings, Adverse reactionsExact identifier
application number: M007
citromaMAGNESIUM CITRATERetail Business Services, LLC2f6e9f87-4bff-482b-a54f-f51ca99aac8c2026-02-06Warnings, Adverse reactionsExact identifier
application number: M007
Epsom SaltMAGNESIUM SULFATERetail Business Services, LLC1a8b540c-b66e-4dca-b7af-23705ae247b62026-02-06Warnings, Adverse reactionsExact identifier
application number: M007
Mineral OilMINERAL OILRetail Business Services, LLCb0abcdf9-c226-424f-8970-c2135708c6c82026-02-06Warnings, Adverse reactionsExact identifier
application number: M007
Epsom SaltMAGNESIUM SULFATEPublix Super Markets, Inc.e985e071-5541-456e-ae4d-dba85287fe752026-02-05Warnings, Adverse reactionsExact identifier
application number: M007
citromaMAGNESIUM CITRATEDiscount Drug Marta82a4aa9-c8af-4383-9d92-ba6c596f00952026-02-04WarningsExact identifier
application number: M007
Epsom SaltMAGNESIUM SULFATEDiscount Drug Martb05a94d2-5cc6-4989-9fb8-096e54fa78522026-02-04Warnings, Adverse reactionsExact identifier
application number: M007
Epsom SaltMAGNESIUM SULFATEGrocery Outlet, Inc.3dff4b00-e71a-1dc0-e063-6394a90a715f2026-02-04Warnings, Adverse reactionsExact identifier
application number: M007
Epsom SaltMAGNESIUM SULFATEHARRIS TEETER73065a04-b7cd-437d-9624-f845f5ec93bf2026-02-04Warnings, Adverse reactionsExact identifier
application number: M007
Harris TeeterMINERALHarris Teeter401e3a7e-54be-47cc-88c3-a343f5cbbd102026-02-04Warnings, Adverse reactionsExact identifier
application number: M007
Magnesium CitrateMAGNESIUM CITRATEHy-Vee, Inc.45374a86-80a4-481c-e063-6294a90a381a2026-02-04Warnings, Adverse reactionsExact identifier
application number: M007
Epsom SaltMAGNESIUM SULFATEHy-Vee, Inc.44592ee0-13dd-57b1-e063-6394a90ab4022026-02-04Warnings, Adverse reactionsExact identifier
application number: M007
Epsom SaltMAGNESIUM SULFATECVS Pharmacy, Inc.a78d991a-ba21-4bc4-b8f9-f8dafbddc28f2026-02-03Warnings, Adverse reactionsExact identifier
application number: M007

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1115005docusate sodium 100 MG Oral CapsulePSN84116db2-a7b7-460a-a5e5-8558bd4247815
1115005docusate sodium 100 MG Oral CapsuleSCD84116db2-a7b7-460a-a5e5-8558bd4247815
1115005DOSS Sodium 100 MG Oral CapsuleSY84116db2-a7b7-460a-a5e5-8558bd4247815

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
37808-853-3037808085330300 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (37808-853-30) 2021-10-290000-00-00NoNoCurrent