Cystex

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: Cystex
Generic name: METHENAMINE, SODIUM SALICYLATE
Manufacturer: Clarion Brands, LLC
Product type: HUMAN OTC DRUG
SPL set ID: ac0f9a8c-164a-4908-8b1d-bb714a82550d
SPL ID: 46defc4c-f40a-58df-e063-6394a90a4de6
Version: 3
Effective date: 2025-12-26
Source export date: 2026-10-30
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/2026-10-30/e1583c3c823c7746dc6fefae78ac97d01bb558f7b0936fc3b7d2e673d3319207/drug-label-0003-of-0014.json.zip
Source manifest SHA-256: b11f1f6b476c7417db937215bf14307ef1a0b69465b42b411ad52f42ae36ead3
Import run: 20261102T182004Z
Imported at: 2026-11-02 18:34:53

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 · 15 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
application number		505G(a)(3)	openfda.application_number
brand name		Cystex	openfda.brand_name
generic name		METHENAMINE, SODIUM SALICYLATE	openfda.generic_name
manufacturer name		Clarion Brands, LLC	openfda.manufacturer_name
ndc	package	69693-518-48	openfda.package_ndc
ndc	package	69693-518-24	openfda.package_ndc
ndc	product	69693-518	openfda.product_ndc
ndc11	package	69693051824	derived:openfda.package_ndc
ndc11	package	69693051848	derived:openfda.package_ndc
rxcui		1489934	openfda.rxcui
rxcui		1489932	openfda.rxcui
spl id		46defc4c-f40a-58df-e063-6394a90a4de6	id
spl set id		ac0f9a8c-164a-4908-8b1d-bb714a82550d	set_id
unii		WIQ1H85SYP	openfda.unii
unii		J50OIX95QV	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 Reye's syndrome: Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye's syndrome, a rare but serious illness. Stomach bleeding warning: This product contains a nonsteroidal anti-inflammatory drug (NSAID), which may cause stomach bleeding. The chance is higher if you are 60 or older have stomach ulcers or bleeding problems take a blood thinning (anticoagulant) or steroid drug take other drugs containing an NSAID (aspirin, ibuprofen, naproxen, or others) have 3 or more alcoholic drinks every day while using this product take more or for a longer time than directed

Reported adverse events (FAERS/openFDA)#

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