Home NDC 69168-424 Stool Softener
Product NDC 69168-424
11-digit product format 691680424
Labeler code 69168
Product ID 69168-424_c35dda2c-6127-4f02-9ae2-330b7a22a973
Type HUMAN OTC DRUG
Nonproprietary name Docusate Sodium
Dosage form CAPSULE, LIQUID FILLED
Route ORAL
Labeler Allegiant Health
Application M007
Marketing category OTC MONOGRAPH DRUG
Marketing start 2015-01-28
Substance DOCUSATE SODIUM
Active strength 100 mg/1
NDC exclude flag No
Listing certified through 2026-12-31
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 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 69168-424-32 Stool Softener 100 in 1 BOTTLE CAPSULE, LIQUID FILLED 100 6 69168-424-81 Stool Softener 400 in 1 BOTTLE CAPSULE, LIQUID FILLED 400 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 69168-424 STOOL SOFTENER (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [ALLEGIANT HEALTH] 6 Current NDC, Legacy NDC, 2 package rows 20231116_9fbe783e-ddd9-445a-852a-00f4ad754880.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 30 of 42 · 833 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 69168-424-32 69168042432 100 CAPSULE, LIQUID FILLED in 1 BOTTLE (69168-424-32) 2022-05-20 0000-00-00 No No Current 69168-424-81 69168042481 400 CAPSULE, LIQUID FILLED in 1 BOTTLE (69168-424-81) 2021-04-20 0000-00-00 No No Current