FDA.reportPublic FDA data

NDC11 54738011613

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
54738-0116-1354738-0116
54738-116-1354738-116

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 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Diphenhydramine HydrochlorideDIPHENHYDRAMINE HYDROCHLORIDERichmond Pharmaceuticals Inc.f184b2aa-91a4-44f9-b688-d4e3181819842024-12-26WarningsExact identifier
ndc (package): 54738-116-13
ndc (product): 54738-116
ndc11 (package): 54738011613
Diphenhydramine HydrochlorideDIPHENHYDRAMINE HYDROCHLORIDERichmond Pharmaceuticals, Inc.ab67121e-2477-47dd-a7ec-114453df3fd42017-10-30WarningsExact identifier
ndc (product): 54738-116

Reported adverse events (FAERS/openFDA)#

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