Home NDC 68391-730 Stool Softener
Product NDC 68391-730
11-digit product format 683910730
Labeler code 68391
Product ID 68391-730_3c12b695-d508-de0f-e063-6394a90a05dd
Type HUMAN OTC DRUG
Nonproprietary name Docusate Sodium
Dosage form CAPSULE
Route ORAL
Labeler BJWC (Berkley & Jensen / BJ's)
Application M007
Marketing category OTC MONOGRAPH DRUG
Marketing start 2025-08-20
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 68391-730-40 Stool Softener 400 in 1 BOTTLE CAPSULE 400 2
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 Units Marketing start Sample Exclude flag Status 68391-730-40 68391073040 400 CAPSULE in 1 BOTTLE (68391-730-40) 400 capsule 2025-08-20 No No Current