Home NDC 53225-2001 Prolaxa
Product NDC 53225-2001
11-digit product format 532252001
Labeler code 53225
Product ID 53225-2001_37683907-1819-da31-e063-6394a90acc44
Type HUMAN OTC DRUG
Nonproprietary name Docusate Sodium 250mg
Dosage form CAPSULE, LIQUID FILLED
Route ORAL
Labeler Terrain Pharmaceuticals
Application M007
Marketing category OTC MONOGRAPH DRUG
Marketing start 2025-04-15
Substance DOCUSATE SODIUM
Active strength 250 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 Prolaxa
Listing expiration 2026-12-31 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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1245468 Internal RxNorm lookup 2711894 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 53225-2001-1 Prolaxa 100 in 1 BOTTLE, PLASTIC CAPSULE, LIQUID FILLED 100 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 53225-2001 PROLAXA (DOCUSATE SODIUM 250MG) CAPSULE, LIQUID FILLED [TERRAIN PHARMACEUTICALS] 1 Current NDC, 1 package rows 20250416_32610e42-f352-09fd-e063-6394a90abff6.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 Sample Exclude flag Status 53225-2001-1 53225200101 100 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (53225-2001-1) 2025-04-15 No No Current