Home NDC 68391-853 Stool Softener Laxative
Product NDC 68391-853
11-digit product format 683910853
Labeler code 68391
Product ID 68391-853_84cdf017-be92-4126-93f8-64e3dfec62b2
Type HUMAN OTC DRUG
Nonproprietary name DOCUSATE SODIUM
Dosage form CAPSULE, LIQUID FILLED
Route ORAL
Labeler BJWC (Berkley & Jensen / BJ's)
Application M007
Marketing category OTC MONOGRAPH DRUG
Marketing start 2021-01-29
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 Laxative
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.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 68391-853-40 Stool Softener Laxative 400 in 1 BOTTLE, PLASTIC CAPSULE, LIQUID FILLED 400 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68391-853 STOOL SOFTENER LAXATIVE (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [BJWC (BERKLEY & JENSEN / BJ'S)] 3 Current NDC, Legacy NDC, 1 package rows 20240224_4ce62421-97e0-4920-9a6d-9fa1f0f93fe4.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 Marketing start Marketing end Sample Exclude flag Status 68391-853-40 68391085340 400 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (68391-853-40) 2021-01-29 0000-00-00 No No Current