Home NDC 41163-778 Stool Softener
Product NDC 41163-778
11-digit product format 411630778
Labeler code 41163
Product ID 41163-778_b0672540-0f64-4d5d-ade2-16a05d40ba75
Type HUMAN OTC DRUG
Nonproprietary name docusate sodium and sennosides
Dosage form TABLET
Route ORAL
Labeler United Natural Foods, Inc. dba UNFI
Application M007
Marketing category OTC MONOGRAPH DRUG
Marketing start 2021-06-25
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
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.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 41163-778-10 Stool SoftenerPlus Stimulant 100 in 1 BOTTLE, PLASTIC TABLET 100 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 41163-778 STOOL SOFTENER PLUS STIMULANT (DOCUSATE SODIUM AND SENNOSIDES) TABLET [UNITED NATURAL FOODS, INC. DBA UNFI] 3 Current NDC, Legacy NDC, 1 package rows 20240616_6c8c7c46-3ded-4e89-8e16-30eeb72aa08b.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 Units Marketing start Marketing end Sample Exclude flag Status 41163-778-10 41163077810 100 TABLET in 1 BOTTLE, PLASTIC (41163-778-10) 100 tablet 2021-06-25 0000-00-00 No No Current