Home NDC 69693-512-48 Cystex
Product NDC 69693-512
Requested package NDC 69693-512-48
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 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
Brand name suffix Plus
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength METHENAMINE 162 mg/1 SODIUM SALICYLATE 162.5 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination J50OIX95QV Internal UNII lookup WIQ1H85SYP Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1489932 Internal RxNorm lookup 1489934 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded Methenamine ACTIVE INGREDIENT J50OIX95QV CYSTEX PLUS (METHENAMINE, SODIUM SALICYLATE) TABLET [CLARION BRANDS, LLC] 1 Sodium Salicylate ACTIVE INGREDIENT WIQ1H85SYP CYSTEX PLUS (METHENAMINE, SODIUM SALICYLATE) TABLET [CLARION BRANDS, LLC] 1 Methenamine ACTIVE MOIETY J50OIX95QV CYSTEX PLUS (METHENAMINE, SODIUM SALICYLATE) TABLET [CLARION BRANDS, LLC] 1 Salicylic Acid ACTIVE MOIETY O414PZ4LPZ CYSTEX PLUS (METHENAMINE, SODIUM SALICYLATE) TABLET [CLARION BRANDS, LLC] 1 Benzoic Acid INACTIVE INGREDIENT 8SKN0B0MIM CYSTEX PLUS (METHENAMINE, SODIUM SALICYLATE) TABLET [CLARION BRANDS, LLC] 1 Croscarmellose Sodium INACTIVE INGREDIENT M28OL1HH48 CYSTEX PLUS (METHENAMINE, SODIUM SALICYLATE) TABLET [CLARION BRANDS, LLC] 1 Fd&c Red No. 40 INACTIVE INGREDIENT WZB9127XOA CYSTEX PLUS (METHENAMINE, SODIUM SALICYLATE) TABLET [CLARION BRANDS, LLC] 1 Fd&c Yellow No. 6 INACTIVE INGREDIENT H77VEI93A8 CYSTEX PLUS (METHENAMINE, SODIUM SALICYLATE) TABLET [CLARION BRANDS, LLC] 1 Hydroxypropyl Cellulose (type H) INACTIVE INGREDIENT RFW2ET671P CYSTEX PLUS (METHENAMINE, SODIUM SALICYLATE) TABLET [CLARION BRANDS, LLC] 1 Hypromelloses INACTIVE INGREDIENT 3NXW29V3WO CYSTEX PLUS (METHENAMINE, SODIUM SALICYLATE) TABLET [CLARION BRANDS, LLC] 1 Magnesium Stearate INACTIVE INGREDIENT 70097M6I30 CYSTEX PLUS (METHENAMINE, SODIUM SALICYLATE) TABLET [CLARION BRANDS, LLC] 1 Methacrylic Acid - Ethyl Acrylate Copolymer (1:1) Type A INACTIVE INGREDIENT NX76LV5T8J CYSTEX PLUS (METHENAMINE, SODIUM SALICYLATE) TABLET [CLARION BRANDS, LLC] 1 Powdered Cellulose INACTIVE INGREDIENT SMD1X3XO9M CYSTEX PLUS (METHENAMINE, SODIUM SALICYLATE) TABLET [CLARION BRANDS, LLC] 1 Silicon Dioxide INACTIVE INGREDIENT ETJ7Z6XBU4 CYSTEX PLUS (METHENAMINE, SODIUM SALICYLATE) TABLET [CLARION BRANDS, LLC] 1 Stearic Acid INACTIVE INGREDIENT 4ELV7Z65AP CYSTEX PLUS (METHENAMINE, SODIUM SALICYLATE) TABLET [CLARION BRANDS, LLC] 1 Titanium Dioxide INACTIVE INGREDIENT 15FIX9V2JP CYSTEX PLUS (METHENAMINE, SODIUM SALICYLATE) TABLET [CLARION BRANDS, LLC] 1 Triethyl Citrate INACTIVE INGREDIENT 8Z96QXD6UM CYSTEX PLUS (METHENAMINE, SODIUM SALICYLATE) TABLET [CLARION BRANDS, LLC] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 69693-512 CYSTEX PLUS (METHENAMINE, SODIUM SALICYLATE) TABLET [CLARION BRANDS, LLC] 10 Current NDC, Legacy NDC, 8 package rows 20241225_62200228-be42-1cda-9493-02bb491537c8.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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 69693-512-48 69693051248 1 BLISTER PACK in 1 CARTON (69693-512-48) / 48 TABLET in 1 BLISTER PACK 1 blister pack 2022-06-01 0000-00-00 No No Current