Home NDC 57896-421 STOOL SOFTENER
Product NDC 57896-421
11-digit product format 578960421
Labeler code 57896
Product ID 57896-421_548956c0-c6c7-be65-e063-6294a90a44fe
Type HUMAN OTC DRUG
Nonproprietary name docusate sodium
Dosage form TABLET
Route ORAL
Labeler Geri-Care Pharmaceuticals, Corp
Application M007
Marketing category OTC MONOGRAPH DRUG
Marketing start 2015-09-01
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
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 1099279 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 57896-421-01 STOOL SOFTENER 100 in 1 BOTTLE TABLET 100 5 57896-421-10 STOOL SOFTENER 1000 in 1 BOTTLE TABLET 1000 5 57896-421-20 STOOL SOFTENER 200 in 1 BOTTLE TABLET 200 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 57896-421 STOOL SOFTENER (DOCUSATE SODIUM) TABLET [GERI-CARE PHARMACEUTICALS, CORP] 5 Current NDC, Legacy NDC, 3 package rows 20241218_3ec42148-6786-22f2-e054-00144ff8d46c.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 43 · 858 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 57896-421-01 57896042101 100 TABLET in 1 BOTTLE (57896-421-01) 100 tablet 2015-09-01 0000-00-00 No No Current 57896-421-10 57896042110 1000 TABLET in 1 BOTTLE (57896-421-10) 1000 tablet 2015-09-01 0000-00-00 No No Current 57896-421-20 57896042120 200 TABLET in 1 BOTTLE (57896-421-20) 200 tablet 2019-05-01 0000-00-00 No No Current