Home NDC 72476-878 Stool Softener
Product NDC 72476-878
11-digit product format 724760878
Labeler code 72476
Product ID 72476-878_e23db7b7-909e-4019-bb58-3a8aa5465cf0
Type HUMAN OTC DRUG
Nonproprietary name docusate sodium and sennosides
Dosage form TABLET
Route ORAL
Labeler Care One (Retail Business Services, LLC.)
Application M007
Marketing category OTC MONOGRAPH DRUG
Marketing start 2020-06-30
Substance DOCUSATE SODIUM; SENNOSIDES
Active strength 50; 8.6 mg/1; 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
Brand name suffix Plus Stimulant Laxative
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DOCUSATE SODIUM 50 mg/1 SENNOSIDES 8.6 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination F05Q2T2JA0 Internal UNII lookup 3FYP5M0IJX Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 998740 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 72476-878-10 Stool SoftenerPlus Stimulant Laxative 100 in 1 BOTTLE, PLASTIC TABLET 100 2 72476-878-10 Stool SoftenerPlus Stimulant Laxative 1 in 1 BOX TABLET 1 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 72476-878 STOOL SOFTENER PLUS STIMULANT LAXATIVE (DOCUSATE SODIUM AND SENNOSIDES) TABLET [CARE ONE (RETAIL BUSINESS SERVICES, LLC.)] 2 Current NDC, Legacy NDC, 2 package rows 20231006_9adaec97-43e3-48f2-96c8-c508b693676c.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 17 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 72476-878-10 72476087810 1 BOTTLE, PLASTIC in 1 BOX (72476-878-10) / 100 TABLET in 1 BOTTLE, PLASTIC 2020-06-30 0000-00-00 No No Current