FDA.reportPublic FDA data

Docu Liquid

Product NDC
50383-771
11-digit product format
503830771
Labeler code
50383
Product ID
50383-771_5ac421b1-7808-4afb-8e1c-706b77b0e090
Type
HUMAN OTC DRUG
Nonproprietary name
Docusate Sodium
Dosage form
LIQUID
Route
ORAL
Labeler
Akorn Operating Company LLC
Application
part334
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
1997-08-01
Marketing end
0000-00-00
Substance
DOCUSATE SODIUM
Active strength
50 mg/5mL
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50383-771-162024-01-30C16284748780-11030e364-fd2b-111a-e063-dadaa90a10e2Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50383-771-16Docu Liquid473 mL in 1 BOTTLELIQUID4739

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50383-771-10ML - Milliliter50383-77160c873a6-cf24-4801-a831-dcc526c5bb3512013-12-02
50383-771-11ML - Milliliter50383-77129633121-268b-41e1-b13b-f36e6603ae7112013-12-02
50383-771-16ML - Milliliter50383-771d151b7ec-cbff-4e36-88b6-7eb23cb551c912012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DOCUSATE SODIUMACTIVE INGREDIENTF05Q2T2JA0DOCU (DOCUSATE SODIUM) LIQUID [HI-TECH PHARMACAL CO., INC.]4
DOCUSATEACTIVE MOIETYM7P27195AGDOCU (DOCUSATE SODIUM) LIQUID [HI-TECH PHARMACAL CO., INC.]4
D&C RED NO. 33INACTIVE INGREDIENT9DBA0SBB0LDOCU (DOCUSATE SODIUM) LIQUID [HI-TECH PHARMACAL CO., INC.]4
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TDOCU (DOCUSATE SODIUM) LIQUID [HI-TECH PHARMACAL CO., INC.]4
POLOXAMER 181INACTIVE INGREDIENT09Y8E6164ADOCU (DOCUSATE SODIUM) LIQUID [HI-TECH PHARMACAL CO., INC.]4
POLYETHYLENE GLYCOL 4000INACTIVE INGREDIENT4R4HFI6D95DOCU (DOCUSATE SODIUM) LIQUID [HI-TECH PHARMACAL CO., INC.]4
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3DOCU (DOCUSATE SODIUM) LIQUID [HI-TECH PHARMACAL CO., INC.]4
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHDOCU (DOCUSATE SODIUM) LIQUID [HI-TECH PHARMACAL CO., INC.]4
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUDOCU (DOCUSATE SODIUM) LIQUID [HI-TECH PHARMACAL CO., INC.]4
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRDOCU (DOCUSATE SODIUM) LIQUID [HI-TECH PHARMACAL CO., INC.]4
WATERINACTIVE INGREDIENT059QF0KO0RDOCU (DOCUSATE SODIUM) LIQUID [HI-TECH PHARMACAL CO., INC.]4
DOCUSATE SODIUMACTIVE INGREDIENTF05Q2T2JA0DOCUSATE SODIUM LIQUID [PHYSICIANS TOTAL CARE, INC.]2
DOCUSATEACTIVE MOIETYM7P27195AGDOCUSATE SODIUM LIQUID [PHYSICIANS TOTAL CARE, INC.]2
D&C RED NO. 33INACTIVE INGREDIENT9DBA0SBB0LDOCUSATE SODIUM LIQUID [PHYSICIANS TOTAL CARE, INC.]2
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TDOCUSATE SODIUM LIQUID [PHYSICIANS TOTAL CARE, INC.]2
POLOXAMER 181INACTIVE INGREDIENT09Y8E6164ADOCUSATE SODIUM LIQUID [PHYSICIANS TOTAL CARE, INC.]2
POLYETHYLENE GLYCOL 4000INACTIVE INGREDIENT4R4HFI6D95DOCUSATE SODIUM LIQUID [PHYSICIANS TOTAL CARE, INC.]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3DOCUSATE SODIUM LIQUID [PHYSICIANS TOTAL CARE, INC.]2
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHDOCUSATE SODIUM LIQUID [PHYSICIANS TOTAL CARE, INC.]2
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUDOCUSATE SODIUM LIQUID [PHYSICIANS TOTAL CARE, INC.]2
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRDOCUSATE SODIUM LIQUID [PHYSICIANS TOTAL CARE, INC.]2
VANILLAINACTIVE INGREDIENTQ74T35078HDOCUSATE SODIUM LIQUID [PHYSICIANS TOTAL CARE, INC.]2
WATERINACTIVE INGREDIENT059QF0KO0RDOCUSATE SODIUM LIQUID [PHYSICIANS TOTAL CARE, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50383-771DOCU LIQUID (DOCUSATE SODIUM) LIQUID [AKORN OPERATING COMPANY LLC]9Legacy NDC, 1 package rows20221015_7fdc4368-4888-4792-86d3-c8a828e4fff2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1248119docusate sodium 50 MG in 5 mL Oral SuspensionPSN7fdc4368-4888-4792-86d3-c8a828e4fff29
1248119docusate sodium 10 MG/ML Oral SuspensionSCD7fdc4368-4888-4792-86d3-c8a828e4fff29
1248119docusate sodium 100 MG per 10 ML Oral SuspensionSY7fdc4368-4888-4792-86d3-c8a828e4fff29
1248119docusate sodium 150 MG per 15 ML Oral SuspensionSY7fdc4368-4888-4792-86d3-c8a828e4fff29
1248119docusate sodium 50 MG per 5 ML Oral SuspensionSY7fdc4368-4888-4792-86d3-c8a828e4fff29
1248119DOSS Sodium 10 MG/ML Oral SuspensionSY7fdc4368-4888-4792-86d3-c8a828e4fff29
1248119docusate sodium 50 MG in 5 mL Oral SuspensionPSNf4ed0721-3be9-4108-a6c9-dbbe115249e93
1248119docusate sodium 10 MG/ML Oral SuspensionSCDf4ed0721-3be9-4108-a6c9-dbbe115249e93
1248119docusate sodium 100 MG per 10 ML Oral SuspensionSYf4ed0721-3be9-4108-a6c9-dbbe115249e93
1248119docusate sodium 150 MG per 15 ML Oral SuspensionSYf4ed0721-3be9-4108-a6c9-dbbe115249e93
1248119docusate sodium 50 MG per 5 ML Oral SuspensionSYf4ed0721-3be9-4108-a6c9-dbbe115249e93
1248119DOSS Sodium 10 MG/ML Oral SuspensionSYf4ed0721-3be9-4108-a6c9-dbbe115249e93
1248119docusate sodium 50 MG in 5 mL Oral SuspensionPSN77651c1d-d9b5-4450-b7de-d786dce701762
1248119docusate sodium 10 MG/ML Oral SuspensionSCD77651c1d-d9b5-4450-b7de-d786dce701762
1248119docusate sodium 100 MG per 10 ML Oral SuspensionSY77651c1d-d9b5-4450-b7de-d786dce701762
1248119docusate sodium 150 MG per 15 ML Oral SuspensionSY77651c1d-d9b5-4450-b7de-d786dce701762
1248119docusate sodium 50 MG per 5 ML Oral SuspensionSY77651c1d-d9b5-4450-b7de-d786dce701762
1248119DOSS Sodium 10 MG/ML Oral SuspensionSY77651c1d-d9b5-4450-b7de-d786dce701762

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50383-771-115038307711110 TRAY in 1 CASE (50383-771-11) > 10 CUP, UNIT-DOSE in 1 TRAY > 10 mL in 1 CUP, UNIT-DOSE (50383-771-10) 10 tray2010-01-130000-00-00NoNoCurrent
50383-771-1650383077116473 mL in 1 BOTTLE (50383-771-16) 473 ml1997-08-010000-00-00NoNoCurrent