FDA.reportPublic FDA data

Docusate Sodium

Product NDC
54629-601
11-digit product format
546290601
Labeler code
54629
Product ID
54629-601_16a5df9c-f9e1-49dc-99cb-b21dfd97e1bf
Type
HUMAN OTC DRUG
Nonproprietary name
Docusate Sodium
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
National Vitamin Company
Application
M007
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2000-05-01
Marketing end
2027-10-31
Substance
DOCUSATE SODIUM
Active strength
250 mg/1
NDC exclude flag
No
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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DOCUSATE SODIUM250 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
1245468Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
0c66642c-82cb-42cd-82bb-5f95852cc5d1Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
54629-601-012020-04-18Docusate Sodium, USP Stool Softener
54629-601-992020-04-18Docusate Sodium, USP Stool Softener
54629-601-012020-01-31Docusate Sodium, USP Stool Softener
54629-601-992020-01-31Docusate Sodium, USP Stool Softener

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54629-601-01Docusate Sodium100 in 1 BOTTLECAPSULE, LIQUID FILLED1003
54629-601-99Docusate Sodium1000 in 1 BOTTLECAPSULE, LIQUID FILLED10003

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
54629-601-01EA - Each54629-601e245c595-3a46-46e1-9d19-668930bf45bd12013-02-13
54629-601-99EA - Each54629-601097fce90-d965-4325-ad79-a72f0644601b12013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DOCUSATE SODIUMACTIVE INGREDIENTF05Q2T2JA0DOCUSATE SODIUM CAPSULE, LIQUID FILLED [NATIONAL VITAMIN COMPANY]1
DOCUSATE SODIUMACTIVE INGREDIENTF05Q2T2JA0DOCUSATE SODIUM CAPSULE, LIQUID FILLED [SAFECOR HEALTH, LLC]1
DOCUSATEACTIVE MOIETYM7P27195AGDOCUSATE SODIUM CAPSULE, LIQUID FILLED [SAFECOR HEALTH, LLC]1
DOCUSATEACTIVE MOIETYM7P27195AGDOCUSATE SODIUM CAPSULE, LIQUID FILLED [NATIONAL VITAMIN COMPANY]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOADOCUSATE SODIUM CAPSULE, LIQUID FILLED [NATIONAL VITAMIN COMPANY]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOADOCUSATE SODIUM CAPSULE, LIQUID FILLED [SAFECOR HEALTH, LLC]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8DOCUSATE SODIUM CAPSULE, LIQUID FILLED [NATIONAL VITAMIN COMPANY]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8DOCUSATE SODIUM CAPSULE, LIQUID FILLED [SAFECOR HEALTH, LLC]1
GELATININACTIVE INGREDIENT2G86QN327LDOCUSATE SODIUM CAPSULE, LIQUID FILLED [SAFECOR HEALTH, LLC]1
GELATININACTIVE INGREDIENT2G86QN327LDOCUSATE SODIUM CAPSULE, LIQUID FILLED [NATIONAL VITAMIN COMPANY]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXDOCUSATE SODIUM CAPSULE, LIQUID FILLED [SAFECOR HEALTH, LLC]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXDOCUSATE SODIUM CAPSULE, LIQUID FILLED [NATIONAL VITAMIN COMPANY]1
POLYETHYLENE GLYCOL 1000INACTIVE INGREDIENTU076Q6Q621DOCUSATE SODIUM CAPSULE, LIQUID FILLED [NATIONAL VITAMIN COMPANY]1
POLYETHYLENE GLYCOL 1000INACTIVE INGREDIENTU076Q6Q621DOCUSATE SODIUM CAPSULE, LIQUID FILLED [SAFECOR HEALTH, LLC]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3DOCUSATE SODIUM CAPSULE, LIQUID FILLED [SAFECOR HEALTH, LLC]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3DOCUSATE SODIUM CAPSULE, LIQUID FILLED [NATIONAL VITAMIN COMPANY]1
SORBITOLINACTIVE INGREDIENT506T60A25RDOCUSATE SODIUM CAPSULE, LIQUID FILLED [NATIONAL VITAMIN COMPANY]1
SORBITOLINACTIVE INGREDIENT506T60A25RDOCUSATE SODIUM CAPSULE, LIQUID FILLED [SAFECOR HEALTH, LLC]1
WATERINACTIVE INGREDIENT059QF0KO0RDOCUSATE SODIUM CAPSULE, LIQUID FILLED [SAFECOR HEALTH, LLC]1
WATERINACTIVE INGREDIENT059QF0KO0RDOCUSATE SODIUM CAPSULE, LIQUID FILLED [NATIONAL VITAMIN COMPANY]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54629-601DOCUSATE SODIUM CAPSULE, LIQUID FILLED [NATIONAL VITAMIN COMPANY]3Current NDC, Legacy NDC, 2 package rows20241228_0c66642c-82cb-42cd-82bb-5f95852cc5d1.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 38 of 42 · 829 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Stool Softener LaxativeDOCUSATE SODIUMBJWC (Berkley & Jensen / BJ's)2ca80e23-f38a-4f77-b536-131cc9f0cf5b2024-02-23WarningsExact identifier
application number: M007
Colon DetoxDOCUSATE SODIUM AND SENNOSIDESOPMX LLC0a4d3265-080c-d2ed-e063-6394a90adbee2024-02-21WarningsExact identifier
application number: M007
Stool Softener LaxativeDOCUSATE SODIUM AND SENNOSIDESBest Choice (Valu Merchandisers Company)4501d718-15a7-4e27-bdb1-8aa2d3ff06d02024-02-20WarningsExact identifier
application number: M007
Stool Softener LaxativeDOCUSATE SODIUMBest Choice (Valu Merchandisers Company)72bd251b-4e82-41ef-8362-39f95faf99162024-02-15WarningsExact identifier
application number: M007
Magnesium CitrateLEADER MAGNESIUM CITRATE ORAL SOLUTION - LEMONCARDINAL HEALTH, INC. 06399736010bdd5e6-3db2-8f9e-e063-6394a90a9b3f2024-02-06WarningsExact identifier
application number: M007
Magnesium CitrateLEADER MAGNESIUM CITRATE ORAL SOLUTION - GRAPECARDINAL HEALTH, INC. 06399736010beb3ec-a189-221d-e063-6394a90aabb52024-02-06WarningsExact identifier
application number: M007
Magnesium CitrateLEADER MAGNESIUM CITRATE ORAL SOLUTION - CHERRYCARDINAL HEALTH, INC. 06399736010bebb63-19b3-2e14-e063-6394a90a8d4e2024-02-06WarningsExact identifier
application number: M007
Docusate SodiumDOCUSATE SODIUMProficient Rx LPf9ac0344-5864-4ac1-81bc-16878a5946c52024-02-01WarningsExact identifier
application number: M007
Purifi Hand SanitizerBENZALKONIUM CHLORIDEPurifi LLC9267069d-4cf5-4e48-a446-7dbebea16bf52024-01-31WarningsExact identifier
application number: M007
WOMENS LAXATIVE ENTERIC COATEDBISACODYLCARDINAL HEALTHab34bc89-6738-d284-e053-2a95a90a5dc92024-01-11WarningsExact identifier
application number: M007
MAXIMUM STRENGTH LAXATIVESENNOSIDESCARDINAL HEALTHb7b13bfa-8a94-6f62-e053-2995a90abbf42024-01-10WarningsExact identifier
application number: M007
FIBER LAXATIVECALCIUM POLYCARBOPHILMagno-Humphries, Inc.e4a921c5-1cf7-12ca-e053-2a95a90a6e042024-01-03WarningsExact identifier
application number: M007
Freskaro Castor OilCASTOR OILPharma Nobis, LLCfbd6bdd5-a7a1-3f28-e053-6294a90aab872023-12-28WarningsExact identifier
application number: M007
Humco Castor OilCASTOR OILPharma Nobis, LLCe42f9d37-1b07-177a-e053-2a95a90a9b062023-12-26WarningsExact identifier
application number: M007
Magnesium CitrateFRESKARO MAGNESIUM CITRATE ORAL SOLUTION - LEMONPharma Nobis, LLCf0477328-eca1-9043-e053-2995a90aaa3d2023-12-22WarningsExact identifier
application number: M007
Magnesium CitrateFRESKARO MAGNESIUM CITRATE ORAL SOLUTION - CHERRYPharma Nobis, LLCf0489f6f-9e60-7d69-e053-2a95a90a9dfb2023-12-22WarningsExact identifier
application number: M007
Magnesium CitrateFRESKARO MAGNESIUM CITRATE ORAL SOLUTION - GRAPEPharma Nobis, LLCf0488c86-6c74-3987-e053-2a95a90a31b42023-12-22WarningsExact identifier
application number: M007
Mineral Oil HeavyMINERAL OILPharma Nobis, LLCe42f6c6d-c4de-02c6-e053-2995a90a3ace2023-12-22WarningsExact identifier
application number: M007
Quality Choice Castor OilCASTOR OILChain Drug Market Asociation18d7124f-7745-45b2-adc4-cb1103add5d62023-12-20WarningsExact identifier
application number: M007
Premiere Value Castor OilCASTOR OILChain Drug Consortium5c8c1564-fcff-894b-e053-2991aa0a9c0b2023-12-20WarningsExact identifier
application number: M007

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1245468docusate sodium 250 MG Oral CapsulePSNf31a4349-7826-45c0-9388-6b938d167b7a9
1245468docusate sodium 250 MG Oral CapsuleSCDf31a4349-7826-45c0-9388-6b938d167b7a9
1245468DOSS Sodium 250 MG Oral CapsuleSYf31a4349-7826-45c0-9388-6b938d167b7a9
1245468docusate sodium 250 MG Oral CapsulePSN6a7e4193-22d2-491e-9842-5c43f571fc656
1245468docusate sodium 250 MG Oral CapsuleSCD6a7e4193-22d2-491e-9842-5c43f571fc656
1245468DOSS Sodium 250 MG Oral CapsuleSY6a7e4193-22d2-491e-9842-5c43f571fc656
1245468docusate sodium 250 MG Oral CapsulePSN0c66642c-82cb-42cd-82bb-5f95852cc5d13
1245468docusate sodium 250 MG Oral CapsuleSCD0c66642c-82cb-42cd-82bb-5f95852cc5d13
1245468DOSS Sodium 250 MG Oral CapsuleSY0c66642c-82cb-42cd-82bb-5f95852cc5d13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
54629-601-0154629060101100 CAPSULE, LIQUID FILLED in 1 BOTTLE (54629-601-01) 2000-05-012027-10-31NoNoCurrent
54629-601-99546290601991000 CAPSULE, LIQUID FILLED in 1 BOTTLE (54629-601-99) 2000-05-012027-10-31NoNoCurrent