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

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 Identifiers#

Field, Values table
FieldValues
UniiJ50OIX95QV, WIQ1H85SYP
Rxcui1489932, 1489934

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

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 pack2024-11-01NoNoHistorical
69693-518-48696930518481 BLISTER PACK in 1 CARTON (69693-518-48) / 48 TABLET in 1 BLISTER PACK1 blister pack2024-11-01NoNoHistorical