Home NDC 53345-035 Docusate Sodium
Product NDC 53345-035
11-digit product format 533450035
Labeler code 53345
Product ID 53345-035_27680f73-0432-5efe-e063-6394a90ae8b7
Type HUMAN OTC DRUG
Nonproprietary name Docusate Sodium
Dosage form CAPSULE, LIQUID FILLED
Route ORAL
Labeler Humanwell PuraCap Pharmaceuticals (Wuhan) Co., Ltd
Application M007
Marketing category OTC MONOGRAPH DRUG
Marketing start 2016-02-10
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 Docusate Sodium
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 · 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.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 53345-035-01 Docusate Sodium 7000 in 1 BAG CAPSULE, LIQUID FILLED 7000 3 53345-035-01 Docusate Sodium 1 in 1 BOX CAPSULE, LIQUID FILLED 1 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 53345-035 DOCUSATE SODIUM CAPSULE, LIQUID FILLED [HUMANWELL PURACAP PHARMACEUTICALS (WUHAN) CO., LTD] 3 Current NDC, Legacy NDC, 2 package rows 20241122_33251cb7-b7b1-4f6c-9e10-4fa64cbf03a0.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 14 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 Marketing end Sample Exclude flag Status 53345-035-01 53345003501 1 BAG in 1 BOX (53345-035-01) / 7000 CAPSULE, LIQUID FILLED in 1 BAG 1 bag 2016-02-10 0000-00-00 No No Current