Methenamine Mandelate

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: Methenamine Mandelate
Generic name: METHENAMINE MANDELATE
Manufacturer: Chartwell RX, LLC
Product type: HUMAN PRESCRIPTION DRUG
SPL set ID: 69efa19c-64a2-41cb-a298-6e9113e57fd7
SPL ID: 00225fc8-eb0d-a4cc-e063-6394a90a2acb
Version: 3
Effective date: 2023-07-10
Source export date: 2026-09-28
Source partition: 14
Source file: https://download.open.fda.gov/drug/label/drug-label-0014-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-09-28/db99fd80353afecef4949b48edcaa018be72b966b2360184251eb14df43743f9/drug-label-0014-of-0014.json.zip
Source manifest SHA-256: cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run: 20260929T050834Z
Imported at: 2026-09-29 06:39:59

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 · 22 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
brand name		Methenamine Mandelate	openfda.brand_name
generic name		METHENAMINE MANDELATE	openfda.generic_name
manufacturer name		Chartwell RX, LLC	openfda.manufacturer_name
ndc	package	62135-200-01	openfda.package_ndc
ndc	package	62135-200-60	openfda.package_ndc
ndc	package	62135-201-60	openfda.package_ndc
ndc	package	62135-201-01	openfda.package_ndc
ndc	package	62135-200-12	openfda.package_ndc
ndc	package	62135-201-12	openfda.package_ndc
ndc	product	62135-201	openfda.product_ndc
ndc	product	62135-200	openfda.product_ndc
ndc11	package	62135020012	derived:openfda.package_ndc
ndc11	package	62135020101	derived:openfda.package_ndc
ndc11	package	62135020112	derived:openfda.package_ndc
ndc11	package	62135020060	derived:openfda.package_ndc
ndc11	package	62135020160	derived:openfda.package_ndc
ndc11	package	62135020001	derived:openfda.package_ndc
rxcui		992184	openfda.rxcui
rxcui		992153	openfda.rxcui
spl id		00225fc8-eb0d-a4cc-e063-6394a90a2acb	id
spl set id		69efa19c-64a2-41cb-a298-6e9113e57fd7	set_id
unii		695N30CINR	openfda.unii

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 Methenamine mandelate should be avoided in patients with gout because it may precipitate urate crystals in their urine. A similar situation may arise in patients with a predisposition to the formation of uric acid stones. Methenamine preparations should not be given to patients taking sulfonamides because some sulfonamides may form an insoluble precipitate with formaldehyde in the urine.

Adverse reactions cross-check#

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

adverse reactions

ADVERSE REACTIONS Gastrointestinal disturbances (nausea, stomach upset), generalized skin rash, dysuria, painful or difficult urination may occur occasionally with the use of methenamine preparations. Microscopic and rarely, gross hematuria have been described.

Reported adverse events (FAERS/openFDA)#

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