Home NDC 68016-471 Stool Softener Laxative
Product NDC 68016-471
11-digit product format 680160471
Labeler code 68016
Product ID 68016-471_a6d14c3d-b8dc-430a-b1e8-13c4e5b08319
Type HUMAN OTC DRUG
Nonproprietary name Docusate Sodium
Dosage form CAPSULE, LIQUID FILLED
Route ORAL
Labeler Chain Drug Consortium, LLC
Application M007
Marketing category OTC MONOGRAPH DRUG
Marketing start 2019-11-29
Marketing end 2026-12-31
Substance DOCUSATE SODIUM
Active strength 250 mg/1
NDC exclude flag No
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 Laxative 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 68016-471-01 Stool Softener Laxative 100 in 1 BOTTLE CAPSULE, LIQUID FILLED 100 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68016-471 STOOL SOFTENER LAXATIVE (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [CHAIN DRUG CONSORTIUM, LLC] 4 Current NDC, Legacy NDC, 1 package rows 20240308_09449649-fd57-4446-8264-6c3bdd6621d0.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 Marketing start Marketing end Sample Exclude flag Status 68016-471-01 68016047101 100 CAPSULE, LIQUID FILLED in 1 BOTTLE (68016-471-01) 2019-11-29 2026-12-31 No No Current