FDA.reportPublic FDA data

Cystex

Product NDC
69693-513
Requested package NDC
69693-513-48
11-digit product format
696930513
Labeler code
69693
Product ID
69693-513_46f3cf47-73a9-167f-e063-6294a90a8b57
Type
HUMAN OTC DRUG
Nonproprietary name
methenamine, sodium salicylate
Dosage form
TABLET
Route
ORAL
Labeler
Clarion Brands, LLC
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2022-06-01
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
4fe33a01-90de-451e-8b54-d84304c842d9Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
260b0da6-d3d7-262f-a60f-d4b36d5f1b4dProduct name620251210
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69693-513-24Cystex1 in 1 CARTONTABLET14
69693-513-24Cystex24 in 1 BLISTER PACKTABLET244
69693-513-48Cystex1 in 1 CARTONTABLET14
69693-513-48Cystex48 in 1 BLISTER PACKTABLET484

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69693-513CYSTEX (METHENAMINE, SODIUM SALICYLATE) TABLET [CLARION BRANDS, LLC]3Current NDC, Legacy NDC, 4 package rows20241225_4fe33a01-90de-451e-8b54-d84304c842d9.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, LLC4fe33a01-90de-451e-8b54-d84304c842d92025-12-27WarningsExact identifier
ndc (package): 69693-513-48
ndc (product): 69693-513
ndc11 (package): 69693051348

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1489934CYSTEX PLUS 162 MG / 162.5 MG Oral TabletPSN4fe33a01-90de-451e-8b54-d84304c842d94
1489932methenamine 162 MG / sodium salicylate 162.5 MG Oral TabletPSN4fe33a01-90de-451e-8b54-d84304c842d94
1489934methenamine 162 MG / sodium salicylate 162.5 MG Oral Tablet [Cystex]SBD4fe33a01-90de-451e-8b54-d84304c842d94
1489932methenamine 162 MG / sodium salicylate 162.5 MG Oral TabletSCD4fe33a01-90de-451e-8b54-d84304c842d94
1489934Cystex (methenamine 162 MG / sodium salicylate 162.5 MG) Oral TabletSY4fe33a01-90de-451e-8b54-d84304c842d94

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69693-513-48696930513481 BLISTER PACK in 1 CARTON (69693-513-48) / 48 TABLET in 1 BLISTER PACK1 blister pack2022-06-010000-00-00NoNoCurrent