Cystex

Product NDC
69693-512
11-digit product format
696930512
Labeler code
69693
Product ID
69693-512_485b5018-57ed-90d7-e063-6294a90ae5e2
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
2015-11-01
Substance
METHENAMINE; SODIUM SALICYLATE
Active strength
162; 162.5 mg/1; mg/1
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Cystex
Brand name suffix
Plus
Listing expiration
2027-12-31

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
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
69693-512-20Cystex Plus20 in 1 BLISTER PACKTABLET2013
69693-512-20Cystex Plus1 in 1 CARTONTABLET113
69693-512-24Cystex Plus24 in 1 BLISTER PACKTABLET2413
69693-512-24Cystex Plus1 in 1 CARTONTABLET113
69693-512-40Cystex Plus1 in 1 CARTONTABLET113
69693-512-40Cystex Plus40 in 1 BLISTER PACKTABLET4013
69693-512-48Cystex Plus1 in 1 CARTONTABLET113
69693-512-48Cystex Plus48 in 1 BLISTER PACKTABLET4813

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MethenamineACTIVE INGREDIENTJ50OIX95QVCYSTEX PLUS (METHENAMINE, SODIUM SALICYLATE) TABLET [CLARION BRANDS, LLC]1
Sodium SalicylateACTIVE INGREDIENTWIQ1H85SYPCYSTEX PLUS (METHENAMINE, SODIUM SALICYLATE) TABLET [CLARION BRANDS, LLC]1
MethenamineACTIVE MOIETYJ50OIX95QVCYSTEX PLUS (METHENAMINE, SODIUM SALICYLATE) TABLET [CLARION BRANDS, LLC]1
Salicylic AcidACTIVE MOIETYO414PZ4LPZCYSTEX PLUS (METHENAMINE, SODIUM SALICYLATE) TABLET [CLARION BRANDS, LLC]1
Benzoic AcidINACTIVE INGREDIENT8SKN0B0MIMCYSTEX PLUS (METHENAMINE, SODIUM SALICYLATE) TABLET [CLARION BRANDS, LLC]1
Croscarmellose SodiumINACTIVE INGREDIENTM28OL1HH48CYSTEX PLUS (METHENAMINE, SODIUM SALICYLATE) TABLET [CLARION BRANDS, LLC]1
Fd&c Red No. 40INACTIVE INGREDIENTWZB9127XOACYSTEX PLUS (METHENAMINE, SODIUM SALICYLATE) TABLET [CLARION BRANDS, LLC]1
Fd&c Yellow No. 6INACTIVE INGREDIENTH77VEI93A8CYSTEX PLUS (METHENAMINE, SODIUM SALICYLATE) TABLET [CLARION BRANDS, LLC]1
Hydroxypropyl Cellulose (type H)INACTIVE INGREDIENTRFW2ET671PCYSTEX PLUS (METHENAMINE, SODIUM SALICYLATE) TABLET [CLARION BRANDS, LLC]1
HypromellosesINACTIVE INGREDIENT3NXW29V3WOCYSTEX PLUS (METHENAMINE, SODIUM SALICYLATE) TABLET [CLARION BRANDS, LLC]1
Magnesium StearateINACTIVE INGREDIENT70097M6I30CYSTEX PLUS (METHENAMINE, SODIUM SALICYLATE) TABLET [CLARION BRANDS, LLC]1
Methacrylic Acid - Ethyl Acrylate Copolymer (1:1) Type AINACTIVE INGREDIENTNX76LV5T8JCYSTEX PLUS (METHENAMINE, SODIUM SALICYLATE) TABLET [CLARION BRANDS, LLC]1
Powdered CelluloseINACTIVE INGREDIENTSMD1X3XO9MCYSTEX PLUS (METHENAMINE, SODIUM SALICYLATE) TABLET [CLARION BRANDS, LLC]1
Silicon DioxideINACTIVE INGREDIENTETJ7Z6XBU4CYSTEX PLUS (METHENAMINE, SODIUM SALICYLATE) TABLET [CLARION BRANDS, LLC]1
Stearic AcidINACTIVE INGREDIENT4ELV7Z65APCYSTEX PLUS (METHENAMINE, SODIUM SALICYLATE) TABLET [CLARION BRANDS, LLC]1
Titanium DioxideINACTIVE INGREDIENT15FIX9V2JPCYSTEX PLUS (METHENAMINE, SODIUM SALICYLATE) TABLET [CLARION BRANDS, LLC]1
Triethyl CitrateINACTIVE INGREDIENT8Z96QXD6UMCYSTEX PLUS (METHENAMINE, SODIUM SALICYLATE) TABLET [CLARION BRANDS, LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69693-512CYSTEX PLUS (METHENAMINE, SODIUM SALICYLATE) TABLET [CLARION BRANDS, LLC]10Current NDC, Legacy NDC, 8 package rows20241225_62200228-be42-1cda-9493-02bb491537c8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1489934CYSTEX PLUS 162 MG / 162.5 MG Oral TabletPSN62200228-be42-1cda-9493-02bb491537c813
1489932methenamine 162 MG / sodium salicylate 162.5 MG Oral TabletPSN62200228-be42-1cda-9493-02bb491537c813
1489934methenamine 162 MG / sodium salicylate 162.5 MG Oral Tablet [Cystex]SBD62200228-be42-1cda-9493-02bb491537c813
1489932methenamine 162 MG / sodium salicylate 162.5 MG Oral TabletSCD62200228-be42-1cda-9493-02bb491537c813
1489934Cystex (methenamine 162 MG / sodium salicylate 162.5 MG) Oral TabletSY62200228-be42-1cda-9493-02bb491537c813
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
69693-512-20696930512201 BLISTER PACK in 1 CARTON (69693-512-20) / 20 TABLET in 1 BLISTER PACK1 blister pack2016-05-010000-00-00NoNoCurrent
69693-512-24696930512241 BLISTER PACK in 1 CARTON (69693-512-24) / 24 TABLET in 1 BLISTER PACK1 blister pack2022-06-010000-00-00NoNoCurrent
69693-512-40696930512401 BLISTER PACK in 1 CARTON (69693-512-40) / 40 TABLET in 1 BLISTER PACK1 blister pack2016-05-010000-00-00NoNoCurrent
69693-512-48696930512481 BLISTER PACK in 1 CARTON (69693-512-48) / 48 TABLET in 1 BLISTER PACK1 blister pack2022-06-010000-00-00NoNoCurrent