FDA.reportPublic FDA data

Docusate Sodium Liquid

Product NDC
54859-813
11-digit product format
548590813
Labeler code
54859
Product ID
54859-813_4745fe35-8aba-b427-e063-6394a90ab073
Type
HUMAN OTC DRUG
Nonproprietary name
Docusate Sodium
Dosage form
LIQUID
Route
ORAL
Labeler
LLORENS PHARMACEUTICALS INTERNATIONAL DIVISION
Application
M007
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-12-01
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 Liquid
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DOCUSATE SODIUM50 mg/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiF05Q2T2JA0
Rxcui1248119

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54859-813-16Docusate Sodium Liquid473 mL in 1 BOTTLELIQUID4739

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
54859-813-16ML - Milliliter54859-81325502fa9-6f5b-4d15-898f-034a45e4599b12025-05-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54859-813DOCUSATE SODIUM LIQUID (DOCUSATE SODIUM) LIQUID [LLORENS PHARMACEUTICALS INTERNATIONAL DIVISION]8Current NDC, Legacy NDC, 1 package rows20241228_2d8bdd3e-f6e6-43f5-b3b0-e5a882cae41c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1248119docusate sodium 50 MG in 5 mL Oral SuspensionPSN2d8bdd3e-f6e6-43f5-b3b0-e5a882cae41c9
1248119docusate sodium 10 MG/ML Oral SuspensionSCD2d8bdd3e-f6e6-43f5-b3b0-e5a882cae41c9
1248119docusate sodium 100 MG per 10 ML Oral SuspensionSY2d8bdd3e-f6e6-43f5-b3b0-e5a882cae41c9
1248119docusate sodium 150 MG per 15 ML Oral SuspensionSY2d8bdd3e-f6e6-43f5-b3b0-e5a882cae41c9
1248119docusate sodium 50 MG per 5 ML Oral SuspensionSY2d8bdd3e-f6e6-43f5-b3b0-e5a882cae41c9
1248119DOSS Sodium 10 MG/ML Oral SuspensionSY2d8bdd3e-f6e6-43f5-b3b0-e5a882cae41c9
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
54859-813-1654859081316473 mL in 1 BOTTLE (54859-813-16) 473 ml2021-12-010000-00-00NoNoCurrent