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

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 Identifiers#

Field, Values table
FieldValues
UniiF05Q2T2JA0
Rxcui1248119

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

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 ml2025-03-01NoNoHistorical