FDA.reportPublic FDA data

Docusate Sodium

Product NDC
84447-011
11-digit product format
844470011
Labeler code
84447
Product ID
84447-011_335f41d7-5c23-7c17-e063-6294a90a8f28
Type
HUMAN OTC DRUG
Nonproprietary name
Docusate Sodium
Dosage form
LIQUID
Route
ORAL
Labeler
Belleview Bio Science
Application
M007
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-03-01
Substance
DOCUSATE SODIUM
Active strength
100 mg/10mL
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
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DOCUSATE SODIUM100 mg/10mL

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
335f41d7-5c22-7c17-e063-6294a90a8f28Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84447-011-01Docusate Sodium200000 mL in 1 DRUMLIQUID2000001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84447-011DOCUSATE SODIUM LIQUID [BELLEVIEW BIO SCIENCE]1Current NDC, 1 package rows20250424_335f41d7-5c22-7c17-e063-6294a90a8f28.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 26 of 42 · 829 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LaxativeSENNOSIDESBETTER LIVING BRANDS LLC.f2c5c1e6-3123-c802-e053-2995a90aa0732025-02-12WarningsExact identifier
application number: M007
Vegetable LaxativeSENNOSIDESBETTER LIVING BRANDS LLC.f2c529e4-6738-377c-e053-2995a90aaf382025-02-12WarningsExact identifier
application number: M007
WOMENS GENTLE LAXATIVEBISACODYLCVS HEALTH CORPa95073f3-e1d6-d291-e053-2a95a90aefea2025-02-12WarningsExact identifier
application number: M007
MAXIMUM STRENGTH LAXATIVESENNOSIDESCVS HEALTHb05ee52f-4801-d4ca-e053-2995a90af3482025-02-12WarningsExact identifier
application number: M007
SENNASENNOSIDESReliable 1 Laboratories LLCc8aa7ae9-7d00-db7d-e053-2995a90ae72b2025-02-11WarningsExact identifier
application number: M007
Extra Gentle LaxativeBISACODYLDOLGENCORP INCbe214c4e-f6db-cc8d-e053-2a95a90addf72025-02-10WarningsExact identifier
application number: M007
SENNA-SDOCUSATE SODIUM AND SENNOSIDESKROGERa187045c-c9d6-592a-e053-2995a90adb832025-02-10WarningsExact identifier
application number: M007
SENNA TIMESENNOSIDESTIME CAP LABORATORIES, INC18ec8127-422c-4c1a-8331-58dabce699692025-02-08WarningsExact identifier
application number: M007
SENNA TIME SDOCUSATE SODIUM-SENNOSIDESTIME CAP LABORATORIES, INCdc491692-8d3a-4ccd-a17d-4c630f1225952025-02-08WarningsExact identifier
application number: M007
LAX-TIMESENNOSIDESTIME CAP LABORATORIES, INC74a627fc-00e5-eb78-e053-2991aa0abacc2025-02-08WarningsExact identifier
application number: M007
SENNOSIDES AND DOCUSATE SODIUMSENNOSIDES AND DOCUSATE SODIUMTIME CAP LABORATORIES, INC0ad617e0-10a6-44fa-be62-4f3cc725fb012025-02-08WarningsExact identifier
application number: M007
Sennosides and Docusate SodiumSENNOSIDES, DOCUSATE SODIUMAsclemed USA, Inc.2db546de-20dc-4697-aff2-12471f073b1d2025-02-08WarningsExact identifier
application number: M007
SENNOSIDESSENNOSIDESTIME CAP LABORATORIES, INC7498f5fa-1739-bb6e-e053-2a91aa0a54042025-02-07WarningsExact identifier
application number: M007
Gentle LaxativeMAGNESIUM HYDROXIDEWALMART INC.26b9f247-c242-2925-e063-6394a90a68dd2025-02-06WarningsExact identifier
application number: M007
Docusate SodiumDOCUSATE SODIUMPAI Holdings, LLC dba PAI Pharmae975a3f1-0e1f-4fb8-9c5f-baa75e12f2a52025-02-06WarningsExact identifier
application number: M007
Mineral oilMINERAL OILBest Choice (Valu Merchandisers Company)3ec8a716-60e0-4dfb-adae-ddc53c6139352025-02-04WarningsExact identifier
application number: M007
DOCUSATE SODIUM 50MG SOFTGEL (RED)DOCUSATE SODIUMCVS Pharmacy273e5b52-1cf9-2525-e063-6394a90a8b4f2025-02-04WarningsExact identifier
application number: M007
LaxativeSENNOSIDESWALGREENSf0caba1d-0c09-8496-e053-2995a90a47cf2025-01-30WarningsExact identifier
application number: M007
BisacodylBISACODYL SUPPOSITORIESOncor Pharmaceuticals6f0aefc9-cd5f-4bdd-89c2-b6a80558987c2025-01-24WarningsExact identifier
application number: M007
Stool Softener LaxativeDOCUSATE SODIUMNuCare Pharmaceuticals, Inc.2c65319f-6cf5-aa90-e063-6394a90ad6622025-01-23WarningsExact identifier
application number: M007

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1248119docusate sodium 50 MG in 5 mL Oral SuspensionPSN331277b8-8304-d082-e063-6394a90a4dd31
1248119docusate sodium 50 MG in 5 mL Oral SuspensionPSN335f41d7-5c22-7c17-e063-6294a90a8f281
1248119docusate sodium 10 MG/ML Oral SuspensionSCD331277b8-8304-d082-e063-6394a90a4dd31
1248119docusate sodium 10 MG/ML Oral SuspensionSCD335f41d7-5c22-7c17-e063-6294a90a8f281
1248119docusate sodium 100 MG per 10 ML Oral SuspensionSY331277b8-8304-d082-e063-6394a90a4dd31
1248119docusate sodium 100 MG per 10 ML Oral SuspensionSY335f41d7-5c22-7c17-e063-6294a90a8f281
1248119docusate sodium 150 MG per 15 ML Oral SuspensionSY331277b8-8304-d082-e063-6394a90a4dd31
1248119docusate sodium 150 MG per 15 ML Oral SuspensionSY335f41d7-5c22-7c17-e063-6294a90a8f281
1248119docusate sodium 50 MG per 5 ML Oral SuspensionSY331277b8-8304-d082-e063-6394a90a4dd31
1248119docusate sodium 50 MG per 5 ML Oral SuspensionSY335f41d7-5c22-7c17-e063-6294a90a8f281
1248119DOSS Sodium 10 MG/ML Oral SuspensionSY331277b8-8304-d082-e063-6394a90a4dd31
1248119DOSS Sodium 10 MG/ML Oral SuspensionSY335f41d7-5c22-7c17-e063-6294a90a8f281

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
84447-011-0184447001101200000 mL in 1 DRUM (84447-011-01) 200000 ml2025-03-01NoNoCurrent