FDA.reportPublic FDA data

NDC11 50991054020

This exact 11-digit normalized identifier can correspond to more than one FDA hyphenation. FDA.report preserves the exact identifier and exposes every structurally valid candidate without guessing.

Possible FDA NDC forms#

Package NDC, Product root table
Package NDCProduct root
50991-0540-2050991-0540
50991-540-2050991-540

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 1 of 1 ยท 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Duratuss ACCODEINE PHOSPHATE, DEXBROMPHENIRAMINE MALEATEPoly Pharmaceuticals, Inc.3e5ed178-d5d9-b8d4-e063-6394a90a91db2025-09-09WarningsExact identifier
ndc (package): 50991-540-20
ndc (product): 50991-540
ndc11 (package): 50991054020

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.