FDA.reportPublic FDA data

Docusate Sodium

Product NDC
0121-0935
11-digit product format
001210935
Labeler code
0121
Product ID
0121-0935_5cfc4685-c885-4303-a988-5009cbd8e57b
Type
HUMAN OTC DRUG
Nonproprietary name
Docusate Sodium
Dosage form
LIQUID
Route
ORAL
Labeler
PAI Holdings, LLC dba PAI Pharma
Application
M007
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-08-16
Substance
DOCUSATE SODIUM
Active strength
50 mg/5mL
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 SODIUM50 mg/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiF05Q2T2JA0
Rxcui1245686

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0121-0935-05Docusate Sodium5 mL in 1 CUP, UNIT-DOSELIQUID59
0121-0935-16Docusate Sodium473 mL in 1 BOTTLELIQUID4739
0121-0935-40Docusate Sodium10 in 1 TRAYLIQUID109
0121-0935-40Docusate Sodium4 in 1 CASELIQUID49

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0121-0935-05ML - Milliliter0121-0935bd4be1fb-4d63-4e7c-8bfa-2e34cd4de1c512021-10-08
0121-0935-16ML - Milliliter0121-09353bdd2684-e7df-4efc-abb2-b74bbcf7d51612021-10-08
0121-0935-40ML - Milliliter0121-09353327600b-3340-46f6-b2a4-f6be1a4545bb12021-10-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0121-0935DOCUSATE SODIUM LIQUID [PAI HOLDINGS, LLC DBA PAI PHARMA]9Current NDC, Legacy NDC, 4 package rows20250216_e975a3f1-0e1f-4fb8-9c5f-baa75e12f2a5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1245686docusate sodium 50 MG in 5 mL Oral SolutionPSNe975a3f1-0e1f-4fb8-9c5f-baa75e12f2a59
1245686docusate sodium 10 MG/ML Oral SolutionSCDe975a3f1-0e1f-4fb8-9c5f-baa75e12f2a59
1245686docusate sodium 10 MG per 1 ML Oral SolutionSYe975a3f1-0e1f-4fb8-9c5f-baa75e12f2a59
1245686docusate sodium 100 MG per 10 ML Oral SolutionSYe975a3f1-0e1f-4fb8-9c5f-baa75e12f2a59
1245686docusate sodium 150 MG per 15 ML Oral SolutionSYe975a3f1-0e1f-4fb8-9c5f-baa75e12f2a59
1245686DOSS Sodium 10 MG/ML Oral SolutionSYe975a3f1-0e1f-4fb8-9c5f-baa75e12f2a59

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0121-0935-05001210935055 mL in 1 CUP, UNIT-DOSE5 mlHistorical
0121-0935-1600121093516473 mL in 1 BOTTLE (0121-0935-16) 473 ml2021-08-160000-00-00NoNoCurrent
0121-0935-40001210935404 TRAY in 1 CASE (0121-0935-40) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (0121-0935-05) 4 tray2021-08-160000-00-00NoNoCurrent