Home NDC 68071-3438 DOCUSATE SODIUM
Product NDC 68071-3438
11-digit product format 680713438
Labeler code 68071
Product ID 68071-3438_0919f0ef-9139-b605-e063-6294a90af582
Type HUMAN OTC DRUG
Nonproprietary name DOCUSATE SODIUM
Dosage form CAPSULE, LIQUID FILLED
Route ORAL
Labeler NuCare Pharmaceuticals,Inc.
Application M007
Marketing category OTC MONOGRAPH DRUG
Marketing start 2022-11-15
Substance DOCUSATE SODIUM
Active strength 100 mg/1
NDC exclude flag No
Listing certified through 2026-12-31
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
Listing expiration 2026-12-31 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 68071-3438-3 DOCUSATE SODIUM 30 in 1 BOTTLE, PLASTIC CAPSULE, LIQUID FILLED 30 2 68071-3438-6 DOCUSATE SODIUM 60 in 1 BOTTLE, PLASTIC CAPSULE, LIQUID FILLED 60 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68071-3438 DOCUSATE SODIUM CAPSULE, LIQUID FILLED [NUCARE PHARMACEUTICALS,INC.] 2 Current NDC, 2 package rows 20240815_fdf3c8e1-d554-4cdb-e053-6394a90a542e.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 · 833 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 68071-3438-3 68071343803 30 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (68071-3438-3) 2023-06-12 No No Current 68071-3438-6 68071343806 60 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC (68071-3438-6) 2023-06-12 No No Current