Home NDC 35916-0454 Docusate Sodium and Sennosides
Product NDC 35916-0454
11-digit product format 359160454
Labeler code 35916
Product ID 35916-0454_47db8971-4012-5504-e063-6294a90afd37
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 2024-06-22
Substance SENNOSIDES; DOCUSATE SODIUM
Active strength 8.6; 50 mg/1; mg/1
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Docusate Sodium and Sennosides
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength SENNOSIDES 8.6 mg/1 DOCUSATE SODIUM 50 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 3FYP5M0IJX Internal UNII lookup F05Q2T2JA0 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1791612 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 35916-0454-1 Docusate Sodium and Sennosides 500 in 1 BOTTLE CAPSULE, GELATIN COATED 500 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 35916-0454 DOCUSATE SODIUM AND SENNOSIDES CAPSULE, GELATIN COATED [SOFTGEL HEALTHCARE PVT LTD] 1 Current NDC, 1 package rows 20240623_1ad73079-ebb3-dae7-e063-6294a90a0558.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 17 of 42 · 833 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 35916-0454-1 35916045401 500 CAPSULE, GELATIN COATED in 1 BOTTLE (35916-0454-1) 2024-06-22 No No Current