Home NDC 68196-853 Stool Softener
Product NDC 68196-853
11-digit product format 681960853
Labeler code 68196
Product ID 68196-853_d737c0ad-f89f-4b67-94cd-6837dd086ab0
Type HUMAN OTC DRUG
Nonproprietary name DOCUSATE SODIUM
Dosage form CAPSULE, LIQUID FILLED
Route ORAL
Labeler Sam's West, Inc
Application M007
Marketing category OTC MONOGRAPH DRUG
Marketing start 2021-05-28
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
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.
FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 68196-853-60 Stool Softener 600 in 1 BOTTLE, PLASTIC CAPSULE, LIQUID FILLED 600 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68196-853 STOOL SOFTENER (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [SAM'S WEST, INC] 3 Current NDC, Legacy NDC, 1 package rows 20240522_b14d2495-1092-4063-869f-73a7e8c28708.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 68196-853-60 68196085360 600 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (68196-853-60) 2021-05-28 0000-00-00 No No Current