FDA.reportPublic FDA data

PHENAZOPYRIDINE HYDROCHLORIDE

openFDA label record#

Cross-check layer: This is openFDA JSON-derived label data. Use the corresponding DailyMed SPL as the canonical label.

Verified complete openFDA source JSON (canonical bytes are SHA-256 checked before publication)

Brand name
PHENAZOPYRIDINE HYDROCHLORIDE
Generic name
PHENAZOPYRIDINE HYDROCHLORIDE
Manufacturer
Genus Lifesciences Inc.
Product type
HUMAN PRESCRIPTION DRUG
SPL set ID
991b3b97-9cea-4c48-90a4-ebff55417d98
SPL ID
af00a22c-46a2-4a41-b37e-cffebedead20
Version
2
Effective date
2026-07-14
Source export date
2026-08-01
Source partition
6
Source file
https://download.open.fda.gov/drug/label/drug-label-0006-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-08-01/4d7120b2932458966cd5c2f0e3ab49319f616f09498d059c9ff283a8dac64565/drug-label-0006-of-0014.json.zip
Source manifest SHA-256
bdd1454d0606b622b70458a306b8a10d8a8787db06fd9f46e69c7f7a4524b630
Import run
20260801T225920Z
Imported at
2026-08-01 23:11:15
Harmonized routes table
Harmonized routes
ORAL

Adverse reactions cross-check#

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Adverse reactions sections page 1 of 1 · 1 matching rows.

adverse reactions

ADVERSE REACTIONS Headache, rash, pruritus and occasional gastrointestinal disturbance. An anaphylactoid-like reaction has been described. Methemoglobinemia, hemolytic anemia, renal and hepatic toxicity have been reported, usually at overdosage levels (see OVERDOSAGE section). To report SUSPECTED ADVERSE REACTIONS, contact Allucent at 1-866-511-6754 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.