Phenazopyridine Hydrochloride

openFDA label record#

This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.

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

Brand name: Phenazopyridine Hydrochloride
Generic name: PHENAZOPYRIDINE
Manufacturer: REMEDYREPACK INC.
Product type: HUMAN PRESCRIPTION DRUG
SPL set ID: 82dc87bb-ba27-4b86-9bc9-18492975ac9f
SPL ID: 53e5fcb2-f144-3739-e063-6394a90a5da0
Version: 10
Effective date: 2026-06-10
Source export date: 2026-10-30
Source partition: 8
Source file: https://download.open.fda.gov/drug/label/drug-label-0008-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-10-30/023bc8d8aae5addb7530087bbbdb169b3ccbf36764f15b8ca67db07e1e5aea8b/drug-label-0008-of-0014.json.zip
Source manifest SHA-256: b11f1f6b476c7417db937215bf14307ef1a0b69465b42b411ad52f42ae36ead3
Import run: 20261102T182004Z
Imported at: 2026-11-02 19:09:44

Harmonized routes table
Harmonized routes
ORAL

Harmonized identifier links#

Every typed identifier imported from the complete openFDA harmonization object is paginated here; values are not reduced to a first match.

Harmonized identifiers page 1 of 1 · 16 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
brand name		Phenazopyridine Hydrochloride	openfda.brand_name
generic name		PHENAZOPYRIDINE	openfda.generic_name
manufacturer name		REMEDYREPACK INC.	openfda.manufacturer_name
ndc	package	70518-3868-3	openfda.package_ndc
ndc	package	70518-3868-2	openfda.package_ndc
ndc	package	70518-3868-1	openfda.package_ndc
ndc	package	70518-3868-0	openfda.package_ndc
ndc	product	70518-3868	openfda.product_ndc
ndc11	package	70518386800	derived:openfda.package_ndc
ndc11	package	70518386803	derived:openfda.package_ndc
ndc11	package	70518386801	derived:openfda.package_ndc
ndc11	package	70518386802	derived:openfda.package_ndc
rxcui		1094104	openfda.rxcui
spl id		53e5fcb2-f144-3739-e063-6394a90a5da0	id
spl set id		82dc87bb-ba27-4b86-9bc9-18492975ac9f	set_id
unii		0EWG668W17	openfda.unii

Adverse reactions cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

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 Amneal Pharmaceuticals at 1-877-835-5472 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Reported adverse events (FAERS/openFDA)#

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