Home NDC 80513-100 DOCUSATE SODIUM, EXTRA STRENGTH
Product NDC 80513-100
11-digit product format 805130100
Labeler code 80513
Product ID 80513-100_220d2464-6ee6-10d6-e063-6394a90a4f39
Type HUMAN OTC DRUG
Nonproprietary name DOCUSATE SODIUM
Dosage form CAPSULE, GELATIN COATED
Route ORAL
Labeler Advanced Rx LLC
Application M007
Marketing category OTC MONOGRAPH DRUG
Marketing start 2022-09-15
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 DOCUSATE SODIUM, EXTRA STRENGTH
Brand name suffix 250 MG
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 80513-100-01 DOCUSATE SODIUM, EXTRA STRENGTH250 MG 100 in 1 BOTTLE CAPSULE, GELATIN COATED 100 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 80513-100 DOCUSATE SODIUM, EXTRA STRENGTH 250 MG (DOCUSATE SODIUM) CAPSULE, GELATIN COATED [ADVANCED RX LLC] 4 Current NDC, Legacy NDC, 1 package rows 20240918_e8be12c5-c591-eadd-e053-2a95a90a431b.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 30 of 42 · 829 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 80513-100-01 80513010001 100 CAPSULE, GELATIN COATED in 1 BOTTLE (80513-100-01) 2022-09-15 0000-00-00 No No Current