Monistat Maintain

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
Monistat Maintain
Generic name
PHENAZOPYRIDINE HYDROCHLORIDE
Manufacturer
Insight Pharmaceuticals LLC
Product type
HUMAN OTC DRUG
SPL set ID
d1e563fc-5a91-4867-8177-93102bd24fe4
SPL ID
e114e8a0-7f90-4363-8d44-eacb4bce5df7
Version
2
Effective date
2025-10-23
Source export date
2026-10-27
Source partition
3
Source file
https://download.open.fda.gov/drug/label/drug-label-0003-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-27/d7629e6f844435cfe6cb0cf8c5341c46775ea16c5af42c77a22a2ffe820a2cd2/drug-label-0003-of-0014.json.zip
Source manifest SHA-256
6be3667a3beefe6c0ead4c723ea963050533a2bc725a8044d58b07d18b258c55
Import run
20261027T193451Z
Imported at
2026-10-27 19:49:47
Harmonized routes table
Harmonized routes
ORAL

Warnings cross-check#

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

Warnings sections page 1 of 1 · 1 matching rows.

warnings

Warnings Do not exceed recommended dosage. Ask a doctor before use if you have kidney disease allergies to foods, preservatives, or dyes had a hypersensitive reaction to phenazopyridine When using this product stomach upset may occur. Taking this product with or after meals may reduce stomach upset. your urine will become reddish-orange in color. This is not harmful, but care should be taken to avoid staining clothing or other items. Stop use and ask a doctor if your symptoms last for more than 2 days you suspect you are having an adverse reaction to the medication experience a yellowish tinge of skin or eyes experience fevers, chills, back pain or bloody urine If pregnant or breast feeding, ask a healthcare professional before use. Keep out of reach of children. In case of an overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Reported adverse events (FAERS/openFDA)#

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