Home NDC 0904-7281 Stool Softener Laxative
Product NDC 0904-7281
11-digit product format 009047281
Labeler code 0904
Product ID 0904-7281_36a66686-4001-4987-bbf4-8291d20c52d4
Type HUMAN OTC DRUG
Nonproprietary name Docusate Sodium
Dosage form CAPSULE, LIQUID FILLED
Route ORAL
Labeler Major Pharmaceuticals
Application M007
Marketing category OTC MONOGRAPH DRUG
Marketing start 2022-10-14
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 Laxative
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 0904-7281-60 Stool Softener Laxative 100 in 1 BOTTLE, PLASTIC CAPSULE, LIQUID FILLED 100 7 0904-7281-80 Stool Softener Laxative 1000 in 1 BOTTLE, PLASTIC CAPSULE, LIQUID FILLED 1000 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0904-7281 STOOL SOFTENER LAXATIVE (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [MAJOR PHARMACEUTICALS] 5 Current NDC, Legacy NDC, 2 package rows 20241219_93ef6486-0930-41e3-a2c6-44af7e37e98b.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 0904-7281-60 00904728160 100 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (0904-7281-60) 2022-10-14 0000-00-00 No No Current 0904-7281-80 00904728180 1000 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (0904-7281-80) 2022-10-14 0000-00-00 No No Current