Home NDC 85111-403 Curewell Docusate Sodium Liquid
Product NDC 85111-403
11-digit product format 851110403
Labeler code 85111
Product ID 85111-403_55901be3-f1c3-f683-e063-6394a90a25fe
Type HUMAN OTC DRUG
Nonproprietary name Docusate Sodium.50mg/5mL
Dosage form SOLUTION
Route ORAL
Labeler RMT HEALTH LLC
Application M007
Marketing category OTC MONOGRAPH DRUG
Marketing start 2026-07-01
Substance DOCUSATE SODIUM
Active strength 50 mg/5mL
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 Curewell Docusate Sodium Liquid
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DOCUSATE SODIUM 50 mg/5mL
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 1245686 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 Units Marketing start Sample Exclude flag Status 85111-403-16 85111040316 1 BOTTLE in 1 BOX (85111-403-16) / 473 mL in 1 BOTTLE 1 bottle 2026-07-01 No No Current