Home NDC 36800-640 Stool Softener
Product NDC 36800-640
11-digit product format 368000640
Labeler code 36800
Product ID 36800-640_ee5db896-6d0e-4b95-a266-18c5bd623d4e
Type HUMAN OTC DRUG
Nonproprietary name Docusate Sodium
Dosage form CAPSULE, LIQUID FILLED
Route ORAL
Labeler TOP CARE (Topco Associates LLC)
Application M007
Marketing category OTC MONOGRAPH DRUG
Marketing start 2025-12-01
Substance DOCUSATE SODIUM
Active strength 250 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
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DOCUSATE SODIUM 250 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 1245468 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 36800-640-10 Stool Softener 100 in 1 BOTTLE, PLASTIC CAPSULE, LIQUID FILLED 100 2
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 Marketing start Sample Exclude flag Status 36800-640-10 36800064010 100 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (36800-640-10) 2025-12-01 No No Current