FDA.reportPublic FDA data

Docusate Sodium - Stool Softener Laxative

Product NDC
0904-7183
11-digit product format
009047183
Labeler code
0904
Product ID
0904-7183_362b3bf1-c0d0-4dee-a2c9-093d772a8b56
Type
HUMAN OTC DRUG
Nonproprietary name
Docusate Sodium
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
Major Pharmaceuticals
Application
M007
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-09-04
Marketing end
2027-08-31
Substance
DOCUSATE SODIUM
Active strength
100 mg/1
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Docusate Sodium - Stool Softener Laxative

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DOCUSATE SODIUM100 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiF05Q2T2JA0
Rxcui1115005

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0904-7183-61Docusate Sodium - Stool Softener Laxative10 in 1 BLISTER PACKCAPSULE, LIQUID FILLED105
0904-7183-61Docusate Sodium - Stool Softener Laxative10 in 1 CARTONCAPSULE, LIQUID FILLED105

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-7183-61EA - Each0904-7183da67df6d-a60f-4a39-8851-7609176262e612021-10-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0904-7183DOCUSATE SODIUM - STOOL SOFTENER LAXATIVE (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [MAJOR PHARMACEUTICALS]3Current NDC, Legacy NDC, 2 package rows20250110_cc8d1556-f108-4166-837c-48f81152877e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1115005docusate sodium 100 MG Oral CapsulePSNb5e4b14d-bf11-4309-bf6d-65ee9d877a245
1115005docusate sodium 100 MG Oral CapsulePSNcc8d1556-f108-4166-837c-48f81152877e5
1115005docusate sodium 100 MG Oral CapsuleSCDb5e4b14d-bf11-4309-bf6d-65ee9d877a245
1115005docusate sodium 100 MG Oral CapsuleSCDcc8d1556-f108-4166-837c-48f81152877e5
1115005DOSS Sodium 100 MG Oral CapsuleSYb5e4b14d-bf11-4309-bf6d-65ee9d877a245
1115005DOSS Sodium 100 MG Oral CapsuleSYcc8d1556-f108-4166-837c-48f81152877e5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0904-7183-610090471836110 BLISTER PACK in 1 CARTON (0904-7183-61) / 10 CAPSULE, LIQUID FILLED in 1 BLISTER PACK10 blister pack2021-09-042027-08-31NoNoCurrent