Docusate Sodium softgels 50mg (Dye Free)

Product NDC
51316-652
11-digit product format
513160652
Labeler code
51316
Product ID
51316-652_584927ea-eb1e-f364-e063-6294a90a9d87
Type
HUMAN OTC DRUG
Nonproprietary name
Docusate Sodium
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
CVS Pharmacy
Application
M007
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-03-06
Substance
DOCUSATE SODIUM
Active strength
50 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
Docusate Sodium softgels 50mg (Dye Free)
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DOCUSATE SODIUM50 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
1247759Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
273ea95f-3c9c-98e8-e063-6294a90a2135Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51316-652-03Docusate Sodium softgels 50mg (Dye Free)1 in 1 CARTONCAPSULE, LIQUID FILLED12
51316-652-03Docusate Sodium softgels 50mg (Dye Free)30 in 1 BOTTLECAPSULE, LIQUID FILLED302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51316-652DOCUSATE SODIUM SOFTGELS 50MG (DYE FREE) (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [CVS PHARMACY]2Current NDC, 2 package rows20250308_273ea95f-3c9c-98e8-e063-6294a90a2135.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 36 of 42 · 833 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Stool Softener LaxativeDOCUSATE SODIUMUnited Natural Foods, Inc. dba UNFIb1d903a5-1d5f-44d4-9939-a4b86e5a620d2024-05-23WarningsExact identifier
application number: M007
Senna laxativeSENNOSIDESUnited Natural Foods, Inc. dba UNFI30b9bbf3-0a64-41de-bfb4-5c8c257cc3e82024-05-23WarningsExact identifier
application number: M007
Gentle LaxativeMAGNESIUM HYDROXIDEMEIJER, INC.11fe5bd0-585a-ad8a-e063-6294a90a3ae82024-05-22WarningsExact identifier
application number: M007
Stool SoftenerDOCUSATE SODIUMSam's West, Incb14d2495-1092-4063-869f-73a7e8c287082024-05-21WarningsExact identifier
application number: M007
Stool Softener Plus Stimulant LaxativeDOCUSATE SODIUM AND SENNOSIDESSafeway, Inc.6bc9ea37-31b8-4a6d-9b2d-2c80bad4f30d2024-05-15WarningsExact identifier
application number: M007
Stool Softener Plus Stimulant LaxativeDOCUSATE SODIUM AND SENNOSIDESSafeway, Inc.c0898583-4bbb-41d5-9e84-00cca823024f2024-05-15WarningsExact identifier
application number: M007
Senna SDOCUSATE SODIUM SENNOSIDESQUALITY CHOICE (Chain Drug Marketing Association)9c986ca8-d540-49c1-b092-94c1bf837c072024-05-09WarningsExact identifier
application number: M007
FleetGLYCERINC.B. Fleet Company, Inc.381f4179-0c3b-41f8-927c-c88534ebe06d2024-05-06WarningsExact identifier
application number: M007
Docusate SodiumDOCUSATE SODIUMNuCare Pharmaceuticals,Inc.ed20d198-e935-200e-e053-2a95a90a309b2024-05-02WarningsExact identifier
application number: M007
Sennosides, Docusate SodiumSENNOSIDES, DOCUSATE SODIUMMajor Pharmaceuticals1768b470-2808-fa46-e063-6394a90ac8d92024-05-01WarningsExact identifier
application number: M007
Stool Softener Stimulant laxativeDOCUSATE SODIUM AND SENNOSIDESQUALITY CHOICE (Chain Drug Marketing Association)9467e1f7-19bb-4fb3-853b-75c4d28bb9a92024-05-01WarningsExact identifier
application number: M007
Stool Softener LaxativeDOCUSATE SODIUM AND SENNOSIDESQUALITY CHOICE (Chain Drug Marketing Association)72f8e8d7-ee38-4bd3-8711-f11fded0cede2024-05-01WarningsExact identifier
application number: M007
Stool Softener Laxative Extra StrengthDOCUSATE SODIUMP & L Development, LLCc1e9863a-c229-4694-b450-6b0e0ad375032024-04-30WarningsExact identifier
application number: M007
Stool Softener LaxativeDOCUSATE SODIUMQUALITY CHOICE (Chain Drug Marketing Association)96c7f8bc-be95-40d1-9977-44b7cc6582df2024-04-22WarningsExact identifier
application number: M007
Pedia-LaxMAGNESIUM HYDROXIDEC.B. Fleet Company, Inc.975f24d8-218c-40f4-84a5-558acf34329d2024-04-11WarningsExact identifier
application number: M007
Stool Softener LaxativeDOCUSATE SODIUM AND SENNOSIDESH E B2f9e2723-53a7-47a8-8c41-87bffc4e50dd2024-04-09WarningsExact identifier
application number: M007
SennaSENNOSIDESH E Bd047e4e9-b8ac-498e-9fde-8af5d415edaa2024-04-09WarningsExact identifier
application number: M007
Stool Softener LaxativeDOCUSATE SODIUMH E B5b8bcc6c-de03-4d73-a76f-6f4c371cf2502024-04-09WarningsExact identifier
application number: M007
Stool SoftenerDOCUSATE SODIUMH E B1dd2be7e-bdca-4e43-b853-3ed10b6366322024-04-08WarningsExact identifier
application number: M007
Stool SoftenerDOCUSATE SODIUMBryant Ranch Prepack1f11cf85-b094-4ca4-8b48-2d3a9093304b2024-04-04WarningsExact identifier
application number: M007

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1247759docusate sodium 50 MG Oral CapsulePSN273ea95f-3c9c-98e8-e063-6294a90a21352
1247759docusate sodium 50 MG Oral CapsuleSCD273ea95f-3c9c-98e8-e063-6294a90a21352
1247759DOSS Sodium 50 MG Oral CapsuleSY273ea95f-3c9c-98e8-e063-6294a90a21352

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
51316-652-03513160652031 BOTTLE in 1 CARTON (51316-652-03) / 30 CAPSULE, LIQUID FILLED in 1 BOTTLE1 bottle2025-03-06NoNoCurrent
51316-652-82513160652821 BOTTLE in 1 CARTON (51316-652-82) / 28 CAPSULE, LIQUID FILLED in 1 BOTTLE1 bottle2025-03-06NoNoCurrent