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 7 of 43 · 858 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Docusate SodiumDOCUSATE SODIUMCardinal Health 107, LLCee14dfe2-405f-493a-a774-ce1b01d05dd42026-05-05WarningsExact identifier
application number: M007
Sennosides, Docusate SodiumSENNOSIDES, DOCUSATE SODIUMCardinal Health 107, LLC1a21b07a-263c-41a4-ba0c-ad2dc5a295d72026-05-05WarningsExact identifier
application number: M007
Docusate Sodium and SennosidesDOCUSATE SODIUM AND SENNOSIDESSOFTGEL HEALTHCARE PRIVATE LIMITED4842a767-bb12-9d85-e063-6294a90a19b52026-04-27WarningsExact identifier
application number: M007
Alcohol wet wipesALCOHOL WET WIPESShandong Aishule Hygiene Products Co., Ltdf79dbac0-cec0-46bc-e053-6294a90a2b132026-04-25WarningsExact identifier
application number: M007
Sterilized wet wipesSTERILIZED WET WIPESShandong Aishule Hygiene Products Co., Ltdf7ca1799-eee4-66f0-e053-6294a90a273f2026-04-25WarningsExact identifier
application number: M007
Wet wipesWET WIPESJINGXIN GROUP (M) SDN BHD395225b1-486b-1867-e063-6394a90a18652026-04-25WarningsExact identifier
application number: M007
Sterilized wet wipesSTERILIZED WET WIPESJINGXIN GROUP (M) SDN BHD3952873e-5e3f-1bff-e063-6294a90a8a622026-04-25WarningsExact identifier
application number: M007
Stool Softener LaxativeDOCUSATE SODIUMPublix Supermarkets, Inc.ed50555f-b105-45c8-9dc4-1bd4d233a1e32026-04-23WarningsExact identifier
application number: M007
Mineral OilMINERAL OILPublix Supermarkets, Inc.382a57d1-85bf-480f-9967-f85da29044102026-04-23WarningsExact identifier
application number: M007
BISACODYLBISACODYLAARNA USA INC.50109967-69af-5fc5-e063-6394a90a87512026-04-22WarningsExact identifier
application number: M007
SennaSENNARugby Laboratories41d53783-7ac2-411c-b9bf-afd87b3af30d2026-04-18WarningsExact identifier
application number: M007
Stool Softener LaxativeDOCUSATE SODIUMUnited Natural Foods, Inc. dba UNFI95bae7bf-f240-4674-9e3c-640a603fdc352026-04-15WarningsExact identifier
application number: M007
Magnesium CitrateMAGNESIUM CITRATEPublix Super Markets, Inc.a4b442f1-d5a6-4cbf-b371-1f6639634f802026-04-13Warnings, Adverse reactionsExact identifier
application number: M007
Magnesium CitrateMAGNESIUM CITRATEPublix Super Markets, Inc.267c434d-3034-491b-b4b1-1d0cbacb16152026-04-13Warnings, Adverse reactionsExact identifier
application number: M007
Stool Softener LaxativeDOCUSATE SODIUMBryant Ranch Prepackd616685a-11fc-4ae0-80de-7d25c0d71ee92026-04-09WarningsExact identifier
application number: M007
Stool Softener LaxativeDOCUSATE SODIUMH E B84116db2-a7b7-460a-a5e5-8558bd4247812026-04-02WarningsExact identifier
application number: M007
MILK OF MAGNESIA ORIGINALMAGNESIUM HYDROXIDEAmerican Health Packaging7d7d789b-b2e7-4600-a025-0cd2ff5b36722026-04-02WarningsExact identifier
application number: M007
Castor OilCASTOR OILSTRATEGIC SOURCING SERVICES4db6736f-416a-f142-e063-6394a90ab08f2026-04-01WarningsExact identifier
application number: M007
Magnesium CitrateMAGNESIUM CITRATEFarmacias De Similares TX LLC4e6a64a0-e453-709b-e063-6294a90a74432026-04-01WarningsExact identifier
application number: M007
Stool Softener LaxativeDOCUSATE SODIUMMajor Pharmaceuticals93ef6486-0930-41e3-a2c6-44af7e37e98b2026-03-31WarningsExact 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