Home NDC 72476-853 Stool Softener Laxative
Product NDC 72476-853
11-digit product format 724760853
Labeler code 72476
Product ID 72476-853_0cf68456-fdad-4cf7-af8f-f50203c4cecf
Type HUMAN OTC DRUG
Nonproprietary name DOCUSATE SODIUM
Dosage form CAPSULE, LIQUID FILLED
Route ORAL
Labeler Care One (Retail Business Services, LLC.)
Application M007
Marketing category OTC MONOGRAPH DRUG
Marketing start 2021-03-26
Substance DOCUSATE SODIUM
Active strength 100 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 Laxative
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DOCUSATE SODIUM 100 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 1115005 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 72476-853-10 Stool Softener Laxative 100 in 1 BOTTLE, PLASTIC CAPSULE, LIQUID FILLED 100 3 72476-853-25 Stool Softener Laxative 250 in 1 BOTTLE, PLASTIC CAPSULE, LIQUID FILLED 250 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 72476-853 STOOL SOFTENER LAXATIVE (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [CARE ONE (RETAIL BUSINESS SERVICES, LLC.)] 3 Current NDC, Legacy NDC, 2 package rows 20240307_16691fd4-cdf3-41d4-b851-5fa148a05468.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 Marketing end Sample Exclude flag Status 72476-853-10 72476085310 100 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (72476-853-10) 2021-03-26 0000-00-00 No No Current 72476-853-25 72476085325 250 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (72476-853-25) 2021-03-26 0000-00-00 No No Current