FDA.reportPublic FDA data

Cystex

Product NDC
69693-518
11-digit product format
696930518
Labeler code
69693
Product ID
69693-518_46defc4c-f40a-58df-e063-6394a90a4de6
Type
HUMAN OTC DRUG
Nonproprietary name
methenamine, sodium salicylate
Dosage form
TABLET
Route
ORAL
Labeler
Clarion Brands, LLC
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-11-01
Substance
METHENAMINE; SODIUM SALICYLATE
Active strength
162; 162.5 mg/1; mg/1
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
Cystex
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
METHENAMINE162 mg/1
SODIUM SALICYLATE162.5 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
J50OIX95QVInternal UNII lookup
WIQ1H85SYPInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1489932Internal RxNorm lookup
1489934Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
ac0f9a8c-164a-4908-8b1d-bb714a82550dAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
260b0da6-d3d7-262f-a60f-d4b36d5f1b4dProduct name620251210
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69693-518-24Cystex1 in 1 CARTONTABLET13
69693-518-24Cystex24 in 1 BLISTER PACKTABLET243
69693-518-48Cystex1 in 1 CARTONTABLET13
69693-518-48Cystex48 in 1 BLISTER PACKTABLET483

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69693-518-48EA - Each69693-51859257d8e-de15-452f-abfd-4383146dc48712025-05-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69693-518CYSTEX (METHENAMINE, SODIUM SALICYLATE) TABLET [CLARION BRANDS, LLC]2Current NDC, 4 package rows20241211_ac0f9a8c-164a-4908-8b1d-bb714a82550d.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CystexMETHENAMINE, SODIUM SALICYLATEClarion Brands, LLCac0f9a8c-164a-4908-8b1d-bb714a82550d2025-12-26WarningsExact identifier
ndc (product): 69693-518

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1489934CYSTEX PLUS 162 MG / 162.5 MG Oral TabletPSNac0f9a8c-164a-4908-8b1d-bb714a82550d3
1489932methenamine 162 MG / sodium salicylate 162.5 MG Oral TabletPSNac0f9a8c-164a-4908-8b1d-bb714a82550d3
1489934methenamine 162 MG / sodium salicylate 162.5 MG Oral Tablet [Cystex]SBDac0f9a8c-164a-4908-8b1d-bb714a82550d3
1489932methenamine 162 MG / sodium salicylate 162.5 MG Oral TabletSCDac0f9a8c-164a-4908-8b1d-bb714a82550d3
1489934Cystex (methenamine 162 MG / sodium salicylate 162.5 MG) Oral TabletSYac0f9a8c-164a-4908-8b1d-bb714a82550d3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
69693-518-24696930518241 BLISTER PACK in 1 CARTON (69693-518-24) / 24 TABLET in 1 BLISTER PACK1 blister pack2024-11-01NoNoCurrent
69693-518-48696930518481 BLISTER PACK in 1 CARTON (69693-518-48) / 48 TABLET in 1 BLISTER PACK1 blister pack2024-11-01NoNoCurrent