FDA.reportPublic FDA data

Docusate Sodium

Product NDC
60687-878
11-digit product format
606870878
Labeler code
60687
Product ID
60687-878_328399bd-5afd-f961-e063-6294a90a7c0a
Type
HUMAN OTC DRUG
Nonproprietary name
Docusate Sodium
Dosage form
LIQUID
Route
ORAL
Labeler
American Health Packaging
Application
M007
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-04-20
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
Rxcui1245686

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
60687-878-42Docusate Sodium10 mL in 1 CUP, UNIT-DOSELIQUID101
60687-878-48Docusate Sodium10 in 1 TRAYLIQUID101
60687-878-56Docusate Sodium10 in 1 CASELIQUID101

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60687-878-42ML - Milliliter60687-8785ce48099-6623-41c4-857a-bf7c1fb1458312025-05-14
60687-878-56ML - Milliliter60687-878b1bc5e56-c291-4fa8-93ec-f726a85a4cba12025-05-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60687-878DOCUSATE SODIUM LIQUID [AMERICAN HEALTH PACKAGING]1Current NDC, 3 package rows20250425_e5028f6d-d33d-47a9-8453-00af5cdf59a6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1245686docusate sodium 50 MG in 5 mL Oral SolutionPSNe5028f6d-d33d-47a9-8453-00af5cdf59a61
1245686docusate sodium 10 MG/ML Oral SolutionSCDe5028f6d-d33d-47a9-8453-00af5cdf59a61
1245686docusate sodium 10 MG per 1 ML Oral SolutionSYe5028f6d-d33d-47a9-8453-00af5cdf59a61
1245686docusate sodium 100 MG per 10 ML Oral SolutionSYe5028f6d-d33d-47a9-8453-00af5cdf59a61
1245686docusate sodium 150 MG per 15 ML Oral SolutionSYe5028f6d-d33d-47a9-8453-00af5cdf59a61
1245686DOSS Sodium 10 MG/ML Oral SolutionSYe5028f6d-d33d-47a9-8453-00af5cdf59a61

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
60687-878-426068708784210 mL in 1 CUP, UNIT-DOSE10 mlHistorical
60687-878-486068708784810 in 1 TRAYHistorical
60687-878-566068708785610 TRAY in 1 CASE (60687-878-56) / 10 CUP, UNIT-DOSE in 1 TRAY (60687-878-48) / 10 mL in 1 CUP, UNIT-DOSE (60687-878-42) 10 tray2025-04-20NoNoHistorical