Home NDC 55154-3369 Docusate Sodium - Stool Softener Laxative
Product NDC 55154-3369
11-digit product format 551543369
Labeler code 55154
Product ID 55154-3369_e7438297-555e-458e-b889-b1ca82d34d96
Type HUMAN OTC DRUG
Nonproprietary name Docusate Sodium
Dosage form CAPSULE, LIQUID FILLED
Route ORAL
Labeler Cardinal Health 107, LLC
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 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 - Stool Softener Laxative Active Ingredients# Ingredient, Strength table Ingredient Strength DOCUSATE SODIUM 100 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 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 1115005 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 55154-3369-0 Docusate Sodium - Stool Softener Laxative 1 in 1 BLISTER PACK CAPSULE, LIQUID FILLED 1 5 55154-3369-0 Docusate Sodium - Stool Softener Laxative 10 in 1 BAG CAPSULE, LIQUID FILLED 10 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 55154-3369 DOCUSATE SODIUM - STOOL SOFTENER LAXATIVE (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [CARDINAL HEALTH 107, LLC] 4 Current NDC, Legacy NDC, 2 package rows 20240112_b5e4b14d-bf11-4309-bf6d-65ee9d877a24.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 14 of 42 · 833 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 55154-3369-0 55154336900 10 BLISTER PACK in 1 BAG (55154-3369-0) / 1 CAPSULE, LIQUID FILLED in 1 BLISTER PACK 10 blister pack 2021-09-04 2027-08-31 No No Current