Home NDC 55319-561 Stool Softener Laxative
Product NDC 55319-561
11-digit product format 553190561
Labeler code 55319
Product ID 55319-561_eafcbba3-e363-4629-b3ad-2f50aebb1a13
Type HUMAN OTC DRUG
Nonproprietary name Docusate Sodium
Dosage form CAPSULE, LIQUID FILLED
Route ORAL
Labeler Family Dollar (FAMILY WELLNESS)
Application M007
Marketing category OTC MONOGRAPH DRUG
Marketing start 2023-07-01
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 Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 55319-561-10 Stool Softener Laxative 100 in 1 BOTTLE, PLASTIC CAPSULE, LIQUID FILLED 100 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 55319-561 STOOL SOFTENER LAXATIVE (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [FAMILY DOLLAR (FAMILY WELLNESS)] 4 Current NDC, 1 package rows 20240328_d61ba4ef-5b03-4d29-b1fd-81591f0c8a2c.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 Sample Exclude flag Status 55319-561-10 55319056110 100 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (55319-561-10) 2023-07-01 No No Current