Home NDC 55319-565 Stool Softener Laxative
Product NDC 55319-565
11-digit product format 553190565
Labeler code 55319
Product ID 55319-565_1dc35b90-2641-4168-a801-212005aef90a
Type HUMAN OTC DRUG
Nonproprietary name Docusate Sodium, Sennosides
Dosage form TABLET
Route ORAL
Labeler Family Dollar (FAMILY WELLNESS)
Application 505G(a)(3)
Marketing category OTC MONOGRAPH DRUG
Marketing start 2023-07-01
Substance DOCUSATE SODIUM; SENNOSIDES
Active strength 50; 8.6 mg/1; 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 Stool Softener Laxative
Listing expiration 2026-12-31 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 55319-565-10 Stool Softener Laxative 100 in 1 BOTTLE, PLASTIC TABLET 100 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 55319-565 STOOL SOFTENER LAXATIVE (DOCUSATE SODIUM, SENNOSIDES) TABLET [FAMILY DOLLAR (FAMILY WELLNESS)] 5 Current NDC, 1 package rows 20240907_1eee3ed5-09f7-44a9-abc5-98336e493fe8.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 1 of 1 · 1 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 55319-565-10 55319056510 100 TABLET in 1 BOTTLE, PLASTIC (55319-565-10) 100 tablet 2023-07-01 No No Current