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 28 of 42 · 833 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Laxative Docusate Sodium with SennaDOCUSATE SODIUM AND SENNOSIDESTOPCO ASSOCIATES LLCcf9075d8-e20e-419a-b996-9b12f49f05f22025-01-01WarningsExact identifier
application number: M007
Vegetable Laxative and Stool SoftnerDOCUSATE SODIUM AND SENNOSIDESTOPCO ASSOCIATES LLCe84d693d-0041-4c11-8f6a-b5c332f79af92025-01-01WarningsExact identifier
application number: M007
AcetaminophenEXTRA STRENGTH PAIN RELIEFNuCare Pharmaceuticals,Inc.a32f346e-71d0-cc11-e053-2a95a90ae88c2024-12-31WarningsExact identifier
application number: M007
LaxacinDOCUSATE SODIUM AND SENNOSIDESAdvanced Rx Pharmacy of Tennessee, LLCfe7d4d75-0f8a-1e7d-e053-6394a90afb4d2024-12-31WarningsExact identifier
application number: M007
NATUREPLEX Enema(SALINE)Natureplex, LLC0bd6d0a8-33e5-40be-a6c6-33fea92b11dd2024-12-31WarningsExact identifier
application number: M007
Magnesium CitrateCVS MAGNESIUM CITRATE ORAL SOLUTION - LEMONCVS Pharmacy, Inc.fb7f9b67-ff0e-3af4-e053-6294a90ac5392024-12-30WarningsExact identifier
application number: M007
Magnesium CitrateCVS MAGNESIUM CITRATE ORAL SOLUTION - GRAPECVS Pharmacy, Inc.fb808dc5-bf80-836c-e053-6294a90a80aa2024-12-30WarningsExact identifier
application number: M007
Magnesium CitrateCVS MAGNESIUM CITRATE ORAL SOLUTION - CHERRYCVS Pharmacy, Inc.fb80ffce-a7b6-7f19-e053-6294a90a5c6b2024-12-30WarningsExact identifier
application number: M007
Foster and Thrive Castor OilCASTOR OILStrategic Sourcing Services, LLC004d1dc2-47c1-84d1-e063-6394a90a24712024-12-30WarningsExact identifier
application number: M007
DOCUSATE SODIUMDOCUSATE SODIUMA-S Medication Solutions946abcdb-96bd-43e6-992a-bb97679c00f02024-12-30WarningsExact identifier
application number: M007
HEB Maximum strength Laxative pillsSENNOSIDESH E B86e5dff5-91e6-47a5-8f3c-b1e86adfc1f42024-12-26WarningsExact identifier
application number: M007
Equaline Regular Strength Chocolated Stimulant LaxativeSENNOSIDESUnited Natural Foods, Inc. dba UNFIe9200d63-a0d1-4f68-bb5e-7507c46cf8002024-12-26WarningsExact identifier
application number: M007
Magnesium CitrateMAGNESIUM CITRATEWALGREEN COMPANYeffad954-b70d-d8e6-e053-2a95a90acaf72024-12-23WarningsExact identifier
application number: M007
Magnesium CitrateMAGNESIUM CITRATEWALGREEN COMPANYeffad365-d76e-71af-e053-2995a90aa0202024-12-23WarningsExact identifier
application number: M007
Magnesium CitrateMAGNESIUM CITRATEWALGREEN COMPANYeffaeff6-c48b-1558-e053-2995a90ab52f2024-12-23WarningsExact identifier
application number: M007
Magnesium CitrateMAGNESIUM CITRATESTRATEGIC SOURCING SERVICESf9e1291a-f64d-2431-e053-6394a90a35f12024-12-23WarningsExact identifier
application number: M007
Magnesium CitrateMAGNESIUM CITRATEAMERISOURCE BERGENf384094e-c4d2-3882-e053-2995a90a77942024-12-23WarningsExact identifier
application number: M007
Magnesium CitrateMAGNESIUM CITRATEAMERISOURCE BERGENf3847b0f-802d-73d7-e053-2a95a90a5bbe2024-12-23WarningsExact identifier
application number: M007
Magnesium CitrateMAGNESIUM CITRATESTRATEGIC SOURCING SERVICESf9e1291a-f650-2431-e053-6394a90a35f12024-12-23WarningsExact identifier
application number: M007
Leader Regular Strength Chocolate Laxative sennosidesSENNOSIDESCARDINAL HEALTH1b7d8486-5b3b-44b7-a7b4-63ee2b836d6e2024-12-23WarningsExact 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