Home NDC 68071-5297 Stool Softener
Product NDC 68071-5297
11-digit product format 680715297
Labeler code 68071
Product ID 68071-5297_53728778-9acd-ab94-e063-6294a90a47ec
Type HUMAN OTC DRUG
Nonproprietary name DOCUSATE SODIUM
Dosage form CAPSULE, LIQUID FILLED
Route ORAL
Labeler NuCare Pharmaceuticals, Inc.
Application M007
Marketing category OTC MONOGRAPH DRUG
Marketing start 2020-04-01
Substance DOCUSATE SODIUM
Active strength 250 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 Stool Softener
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DOCUSATE SODIUM 250 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 1245468 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 68071-5297-6 68071529706 60 CAPSULE, LIQUID FILLED in 1 BOTTLE (68071-5297-6) 2026-06-04 No No Current