FDA.reportPublic FDA data

DOCUSATE SODIUM

Product NDC
48433-220
11-digit product format
484330220
Labeler code
48433
Product ID
48433-220_3b918dfb-629d-4eef-ba71-d2ee2f97747f
Type
HUMAN OTC DRUG
Nonproprietary name
DOCUSATE SODIUM
Dosage form
LIQUID
Route
ORAL
Labeler
Safecor Health, LLC
Application
M334
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-09-01
Substance
DOCUSATE SODIUM
Active strength
50 mg/5mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
DOCUSATE SODIUM
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DOCUSATE SODIUM50 mg/5mL

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
1248119Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
efe4bf81-fb99-4755-aa23-4f8df5973be8Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
48433-220-102023-01-31C16284748780-1f386c649-d87d-0266-e053-dadaa90a7c1aSAFECOR HEALTH Docusate Sodium Liquid Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
48433-220-10DOCUSATE SODIUM10 mL in 1 CUP, UNIT-DOSELIQUID103

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
48433-220-10ML - Milliliter48433-2209184ffe3-708c-47a6-b2d9-0ce1419e907012023-03-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
48433-220DOCUSATE SODIUM LIQUID [SAFECOR HEALTH, LLC]3Current NDC, Legacy NDC, 1 package rows20250110_efe4bf81-fb99-4755-aa23-4f8df5973be8.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 1 of 1 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DOCUSATE SODIUMDOCUSATE SODIUMSafecor Health, LLCefe4bf81-fb99-4755-aa23-4f8df5973be82025-01-08WarningsExact identifier
application number: M334
ndc (product): 48433-220
Mineral OilMINERAL OILSafecor Health, LLCef182484-692e-4eb3-bcf1-3c990ec0d08e2025-01-08WarningsExact identifier
application number: M334
Senna SyrupSENNOSIDESSafecor Health, LLCe1dca0d6-6e6e-4ba2-a7b8-009aeb00ef632025-01-08WarningsExact identifier
application number: M334

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1248119docusate sodium 50 MG in 5 mL Oral SuspensionPSNefe4bf81-fb99-4755-aa23-4f8df5973be83
1248119docusate sodium 10 MG/ML Oral SuspensionSCDefe4bf81-fb99-4755-aa23-4f8df5973be83
1248119docusate sodium 100 MG per 10 ML Oral SuspensionSYefe4bf81-fb99-4755-aa23-4f8df5973be83
1248119docusate sodium 150 MG per 15 ML Oral SuspensionSYefe4bf81-fb99-4755-aa23-4f8df5973be83
1248119docusate sodium 50 MG per 5 ML Oral SuspensionSYefe4bf81-fb99-4755-aa23-4f8df5973be83
1248119DOSS Sodium 10 MG/ML Oral SuspensionSYefe4bf81-fb99-4755-aa23-4f8df5973be83

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
48433-220-104843302201010 mL in 1 CUP, UNIT-DOSE (48433-220-10) 10 ml2021-09-010000-00-00NoNoCurrent