Home NDC 76162-761 Topcare Stool Softener
Product NDC 76162-761
11-digit product format 761620761
Labeler code 76162
Product ID 76162-761_ea68a2b3-9063-4a8b-a5a4-605abd4c23de
Type HUMAN OTC DRUG
Nonproprietary name DOCUSATE SODIUM
Dosage form CAPSULE, LIQUID FILLED
Route ORAL
Labeler TOPCO ASSOCIATES LLC
Application M007
Marketing category OTC MONOGRAPH DRUG
Marketing start 2021-07-20
Substance DOCUSATE SODIUM
Active strength 100 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 Topcare Stool Softener
Listing expiration 2026-12-31 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 76162-761-25 Topcare Stool Softener 25 in 1 BOTTLE CAPSULE, LIQUID FILLED 25 4 76162-761-25 Topcare Stool Softener 1 in 1 CARTON CAPSULE, LIQUID FILLED 1 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 76162-761 TOPCARE STOOL SOFTENER (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [TOPCO ASSOCIATES LLC] 4 Current NDC, Legacy NDC, 2 package rows 20241220_93158bd3-c830-4b12-ab1c-133a4bdb9c78.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 Units Marketing start Marketing end Sample Exclude flag Status 76162-761-25 76162076125 1 BOTTLE in 1 CARTON (76162-761-25) / 25 CAPSULE, LIQUID FILLED in 1 BOTTLE 1 bottle 2021-07-20 0000-00-00 No No Current