Home NDC 63868-875 Stool Softener
Product NDC 63868-875
11-digit product format 638680875
Labeler code 63868
Product ID 63868-875_7309543d-0d54-44ee-9635-302caa83fed5
Type HUMAN OTC DRUG
Nonproprietary name docusate sodium and sennosides
Dosage form TABLET
Route ORAL
Labeler QUALITY CHOICE (Chain Drug Marketing Association)
Application M007
Marketing category OTC MONOGRAPH DRUG
Marketing start 2018-12-31
Substance DOCUSATE SODIUM; SENNOSIDES
Active strength 50; 8.6 mg/1; 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
Brand name suffix Stimulant laxative
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DOCUSATE SODIUM 50 mg/1 SENNOSIDES 8.6 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination F05Q2T2JA0 Internal UNII lookup 3FYP5M0IJX Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 998740 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 63868-875-01 Stool SoftenerStimulant laxative 100 in 1 BOTTLE, PLASTIC TABLET 100 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63868-875 STOOL SOFTENER STIMULANT LAXATIVE (DOCUSATE SODIUM AND SENNOSIDES) TABLET [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)] 4 Current NDC, Legacy NDC, 1 package rows 20240502_9467e1f7-19bb-4fb3-853b-75c4d28bb9a9.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 63868-875-01 63868087501 100 TABLET in 1 BOTTLE, PLASTIC (63868-875-01) 100 tablet 2018-12-31 0000-00-00 No No Current