Stool Softener Laxative

Product NDC
37808-862
11-digit product format
378080862
Labeler code
37808
Product ID
37808-862_f937ec03-9b74-4bbb-bf16-98ebaf6e4222
Type
HUMAN OTC DRUG
Nonproprietary name
DOCUSATE SODIUM
Dosage form
CAPSULE
Route
ORAL
Labeler
H E B
Application
M007
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-04-30
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
5b8bcc6c-de03-4d73-a76f-6f4c371cf250Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
37808-862-10Stool Softener Laxative100 in 1 BOTTLE, PLASTICCAPSULE1003
37808-862-10Stool Softener Laxative1 in 1 BOXCAPSULE13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
37808-862STOOL SOFTENER LAXATIVE (DOCUSATE SODIUM) CAPSULE [H E B]3Current NDC, Legacy NDC, 2 package rows20240410_5b8bcc6c-de03-4d73-a76f-6f4c371cf250.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 14 of 42 · 833 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GENTLE LAXATIVEBISACODYLWal-Mart Stores Inc9b466e37-4c7d-4237-8a9d-2994113707f42026-01-26WarningsExact identifier
application number: M007
Docusate Sodium and SennosidesDOCUSATE SODIUM AND SENNOSIDESMorepen Laboratories Limited3cf42333-7479-940a-e063-6394a90aedee2026-01-23WarningsExact identifier
application number: M007
ROYAL Epsom SaltMAGNESIUM SULFATEFilo America40eb04d2-fcc9-4ee2-8483-99699ea7e3862026-01-22WarningsExact identifier
application number: M007
Milk of MagnesiaMAGNESIUM HYDROXIDEPAI Holdings, LLC dba PAI Pharma2de868a0-c652-473c-8b61-636083b7f7572026-01-22WarningsExact identifier
application number: M007
Dr Simi Regular Strength Sennosides 8.6mgSENNOSIDES 8.6MGFarmacias De Similares TX LLC48ed4c5a-136a-90ba-e063-6294a90affed2026-01-21WarningsExact identifier
application number: M007
Stool Softener LaxativeDOCUSATE SODIUMP & L Development, LLC1f6c3b64-0fcd-4cd3-9947-453d794682922026-01-19WarningsExact identifier
application number: M007
DOCUSATE SODIUMDOCUSATE SODIUMWALGREEN COMPANY21fbddce-d3e7-4090-9e69-f4e07fa97ba22026-01-19WarningsExact identifier
application number: M007
Walgreens Gentle LaxativeBISACODYL SUPPOSITORYWalgreensd094ba43-7404-43c4-b907-41ab6d02a3c32026-01-15WarningsExact identifier
application number: M007
Walgreens Gentle LaxativeBISACODYL SUPPOSITORYWalgreens015e41d2-7543-4210-8345-626f5ae5f81d2026-01-15WarningsExact identifier
application number: M007
Walgreens Adult Glycerin LaxativeGLYCERIN SUPPOSITORYWalgreensf19c6cca-e763-4c38-a546-855f027d20c52026-01-15WarningsExact identifier
application number: M007
Walgreens Adult Glycerin LaxativeGLYCERIN SUPPOSITORYWalgreens1a00ff43-ba79-4339-a547-f9757872958b2026-01-15WarningsExact identifier
application number: M007
Walgreens Gentle LaxativeBISACODYL SUPPOSITORYWalgreens2c30de62-b5d2-4905-90a1-a2f9a339fb272026-01-15WarningsExact identifier
application number: M007
Stool SoftenerDOCUSATE SODIUMTOP CARE (Topco Associates LLC)0ce164a5-6b2f-4a21-9dca-10301a1f812a2026-01-15WarningsExact identifier
application number: M007
Dulcolax Pink Stool SoftenerDOCUSATE SODIUMChattem, Inc.33fefcf1-9985-4797-9a38-8acaf3979fce2026-01-14WarningsExact identifier
application number: M007
SennaSENNOSIDESAmerican Health Packaginge3cbb71b-b45c-4ce1-820b-959dde04360d2026-01-14WarningsExact identifier
application number: M007
CVS Pharmacy Glycerin LaxativeGLYCERINCVS Pharmacya73404d5-7843-4a9a-ad43-613df22f52e72026-01-14WarningsExact identifier
application number: M007
CVS Gentle LaxativeBISACODYLCVS Pharmacy9c6a651a-f062-4784-9d82-156f9f7452232026-01-14WarningsExact identifier
application number: M007
CVS Pharmacy Glycerin LaxativeGLYCERINCVS Pharmacyeff2f43e-5626-48eb-a70e-3344929772042026-01-14WarningsExact identifier
application number: M007
CVS Pharmacy Glycerin LaxativeGLYCERINCVS Pharmacyc92ca67b-bea2-4be0-95ab-15f9b55568c12026-01-14WarningsExact identifier
application number: M007
CVS Gentle LaxativeBISACODYLCVS Pharmacy10a9bd9a-181b-69ba-e063-6294a90ac4582026-01-14WarningsExact identifier
application number: M007

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1115005docusate sodium 100 MG Oral CapsulePSN5b8bcc6c-de03-4d73-a76f-6f4c371cf2503
1115005docusate sodium 100 MG Oral CapsuleSCD5b8bcc6c-de03-4d73-a76f-6f4c371cf2503
1115005DOSS Sodium 100 MG Oral CapsuleSY5b8bcc6c-de03-4d73-a76f-6f4c371cf2503

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
37808-862-10378080862101 BOTTLE, PLASTIC in 1 BOX (37808-862-10) / 100 CAPSULE in 1 BOTTLE, PLASTIC2021-04-300000-00-00NoNoCurrent