Home NDC 36800-084 Stool Softener
Product NDC 36800-084
11-digit product format 368000084
Labeler code 36800
Product ID 36800-084_a1ec806f-8477-4eb3-ae91-ea2e29530f1e
Type HUMAN OTC DRUG
Nonproprietary name docusate sodium and sennosides
Dosage form TABLET
Route ORAL
Labeler TOP CARE (Topco Associates LLC)
Application M007
Marketing category OTC MONOGRAPH DRUG
Marketing start 2016-01-31
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.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 36800-084-01 Stool SoftenerPlus Stimulant Laxative 100 in 1 BOTTLE, PLASTIC TABLET 100 5 36800-084-01 Stool SoftenerPlus Stimulant Laxative 1 in 1 BOX TABLET 1 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 36800-084 STOOL SOFTENER PLUS STIMULANT LAXATIVE (DOCUSATE SODIUM AND SENNOSIDES) TABLET [TOP CARE (TOPCO ASSOCIATES LLC)] 5 Current NDC, Legacy NDC, 2 package rows 20240621_3b184800-649b-45d0-9586-8055d6d7fe08.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 36800-084-01 36800008401 1 BOTTLE, PLASTIC in 1 BOX (36800-084-01) / 100 TABLET in 1 BOTTLE, PLASTIC 2016-01-31 0000-00-00 No No Current