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

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 Liquid
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
2d8bdd3e-f6e6-43f5-b3b0-e5a882cae41cAvailable on FDA.report

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

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 32 of 42 · 833 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
NuValu Epsom SaltMAGNESIUM SULFATE (HEPTAHYDRATE)J C SALES5a503d8d-7899-4b1e-be6f-8e2a759af2652024-12-04WarningsExact identifier
application number: M007
SENNOSIDESSENNOSIDESCVS Pharmacy, Inc.6dffc3f5-bae0-c436-e053-2991aa0a0f8b2024-12-02WarningsExact identifier
application number: M007
Pure and GentleMINERAL OILMedline Industries, LP96d4cad5-0602-4c31-94ed-3117b4fd4a942024-11-26WarningsExact identifier
application number: M007
Pure and Gentle LaxativeSODIUM PHOSPHATEMedline Industries, LPe3165538-75dd-4f0f-adc8-d4075de10f1e2024-11-26WarningsExact identifier
application number: M007
DOCUSATE SODIUM 50 MGDOCUSATE SODIUMHumanwell PuraCap Pharmaceutical (Wuhan), Ltd.af7533e6-8b06-48a4-940e-7ecb57b24b592024-11-25WarningsExact identifier
application number: M007
DOCUSATE SODIUM 100mg Two-ToneDOCUSATE SODIUMHumanwell PuraCap Pharmaceutical (Wuhan), Ltd.a923e5ca-86fd-4bf9-9931-180ddfdeae662024-11-25WarningsExact identifier
application number: M007
DOCUSATE SODIUM 100mg Two-ToneDOCUSATE SODIUMHumanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd.7cf1df18-d658-4bff-8a62-365fc56569422024-11-25WarningsExact identifier
application number: M007
DOCUSATE SODIUM 100mgDOCUSATE SODIUMHumanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd.c5bdfbfc-d24a-4088-9b60-ecea8120ff432024-11-25WarningsExact identifier
application number: M007
DOCUSATE SODIUMDOCUSATE SODIUMHumanwell PuraCap Pharmaceutical (Wuhan), Ltd.b10fdf50-289e-41f3-9b83-a4e4dd892f882024-11-21WarningsExact identifier
application number: M007
DOCUSATE SODIUM 100mg Two-ToneDOCUSATE SODIUMHumanwell PuraCap Pharmaceutical (Wuhan), Ltd.85c64624-428d-46fa-8071-f42b8feec0492024-11-21WarningsExact identifier
application number: M007
Docusate SodiumDOCUSATE SODIUMHumanwell PuraCap Pharmaceuticals (Wuhan) Co., Ltd33251cb7-b7b1-4f6c-9e10-4fa64cbf03a02024-11-21WarningsExact identifier
application number: M007
STOOL SOFTENERDOCUSATE SODIUMWalgreen Co.d8d97ca5-5131-4620-8ce9-bc3f9d5c0ab52024-11-21WarningsExact identifier
application number: M007
4718 Enema, Mineral Oil4718 ENEMA, MINERAL OILDynarex9e51c852-9477-5cf5-e053-2a95a90a97db2024-11-20WarningsExact identifier
application number: M007
ReliefSODIUM PHOSPHATE, MONOBASIC AND SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATELeosons Overseas Corp5b301d5b-1e2c-47ed-a05f-d6be0fdfc9402024-11-19WarningsExact identifier
application number: M007
REFLIEF SALINE LAXATIVE PEDIATRIC READY TO USESODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM AND SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORMLeosons Overseas Corp90e7c2b4-35e1-4a27-afea-9257c480e1902024-11-19WarningsExact identifier
application number: M007
Stool SoftenerDOCUSATE SODIUM 100MGPuraCap Pharmaceutical LLC272c86f1-f229-2ebf-e063-6394a90a34712024-11-18WarningsExact identifier
application number: M007
Milk of Magnesia ConcentrateMAGNESIUM HYDROXIDEPAI Holdings, LLC dba PAI Pharma2a99a1a8-a830-429f-9cfd-3f29c3d3547c2024-11-12WarningsExact identifier
application number: M007
Docusate SodiumDOCUSATE SODIUMA-S Medication Solutions122486e9-74dd-4181-97d1-0b07688280f42024-11-06WarningsExact identifier
application number: M007
Stratuscare Adult GlycerinGLYCERINStratus Pharmaceuticals3e1935da-5c1f-4942-98dd-320fade823212024-11-04WarningsExact identifier
application number: M007
DOCUSATE SODIUMDOCUSATE SODIUMNuCare Pharmaceuticals,Inc.fdf3c8e1-d554-4cdb-e053-6394a90a542e2024-11-01WarningsExact identifier
application number: M007

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