FDA.reportPublic FDA data

Docusate Sodium and Sennosides

Product NDC
35916-0453
11-digit product format
359160453
Labeler code
35916
Product ID
35916-0453_47dbd4d5-5093-0741-e063-6294a90a001a
Type
HUMAN OTC DRUG
Nonproprietary name
Docusate Sodium and Sennosides
Dosage form
CAPSULE, GELATIN COATED
Route
ORAL
Labeler
SOFTGEL HEALTHCARE PRIVATE LIMITED
Application
M007
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-06-04
Substance
DOCUSATE SODIUM; SENNOSIDES
Active strength
50; 8.6 mg/1; mg/1
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Docusate Sodium and Sennosides
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DOCUSATE SODIUM50 mg/1
SENNOSIDES8.6 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiF05Q2T2JA0, 3FYP5M0IJX
Rxcui1791612

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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
35916-0453-1Docusate Sodium and Sennosides500 in 1 BOTTLECAPSULE, GELATIN COATED5003
35916-0453-3Docusate Sodium and Sennosides2 in 1 BOXCAPSULE, GELATIN COATED23
35916-0453-3Docusate Sodium and Sennosides3000 in 1 POUCHCAPSULE, GELATIN COATED30003

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
35916-0453DOCUSATE SODIUM AND SENNOSIDES CAPSULE, GELATIN COATED [SOFTGEL HEALTHCARE PVT LTD]1Current NDC, 3 package rows20240606_19830f9a-27b1-910d-e063-6294a90adace.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1791612sennosides 8.6 MG / docusate sodium 50 MG Oral CapsulePSN19830f9a-27b1-910d-e063-6294a90adace3
1791612docusate sodium 50 MG / sennosides, USP 8.6 MG Oral CapsuleSCD19830f9a-27b1-910d-e063-6294a90adace3
1791612DOSS Sodium 50 MG / sennosides, USP 8.6 MG Oral CapsuleSY19830f9a-27b1-910d-e063-6294a90adace3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
35916-0453-135916045301500 CAPSULE, GELATIN COATED in 1 BOTTLE (35916-0453-1) 2024-06-04NoNoCurrent
35916-0453-3359160453032 POUCH in 1 BOX (35916-0453-3) / 3000 CAPSULE, GELATIN COATED in 1 POUCH2 pouch2025-06-12NoNoCurrent