Home NDC 50804-424 Stool Softener
Product NDC 50804-424
11-digit product format 508040424
Labeler code 50804
Product ID 50804-424_352f3947-64f9-4453-b954-e174260b93c7
Type HUMAN OTC DRUG
Nonproprietary name Stool Softener
Dosage form CAPSULE, LIQUID FILLED
Route ORAL
Labeler Good Sense
Application M007
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-06-18
Substance DOCUSATE SODIUM
Active strength 100 mg/1
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 2 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 50804-424 50804-424-24 D Discontinued by firm excluded / ndc_excluded.zip d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 50804-424 50804-424-24 D Discontinued by firm excluded / ndc_excluded.zip f5e01cc5f278…a2eaf40c39c3…
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 Stool Softener
Listing expiration 2026-12-31 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 50804-424-24 Stool Softener 1 in 1 CARTON CAPSULE, LIQUID FILLED 1 2 50804-424-24 Stool Softener 25 in 1 BOTTLE CAPSULE, LIQUID FILLED 25 2 50804-424-25 Stool Softener 1 in 1 CARTON CAPSULE, LIQUID FILLED 1 2 50804-424-25 Stool Softener 25 in 1 BOTTLE CAPSULE, LIQUID FILLED 25 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50804-424 STOOL SOFTENER CAPSULE, LIQUID FILLED [GOOD SENSE] 1 Current NDC, 4 package rows 20240619_64266195-1b07-42c2-98a7-d76c12f74776.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 Sample Exclude flag Status 50804-424-24 50804042424 1 in 1 CARTON Historical 50804-424-25 50804042425 1 BOTTLE in 1 CARTON (50804-424-25) / 25 CAPSULE, LIQUID FILLED in 1 BOTTLE 1 bottle 2024-06-18 No No Current