FDA.reportPublic FDA data

Azo Urinary Tract Defense

Product NDC
49973-011
11-digit product format
499730011
Labeler code
49973
Product ID
49973-011_4472aec7-dd1f-0230-e063-6394a90abe72
Type
HUMAN OTC DRUG
Nonproprietary name
Methenamine, Sodium salicylate
Dosage form
TABLET
Route
ORAL
Labeler
i-Health, Inc.
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2015-11-06
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
Azo Urinary Tract Defense
Brand name suffix
Antibacterial Protection
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, 1721434

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
49973-011-04Azo Urinary Tract DefenseAntibacterial Protection4 in 1 POUCHTABLET47
49973-011-18Azo Urinary Tract DefenseAntibacterial Protection18 in 1 BLISTER PACKTABLET187
49973-011-18Azo Urinary Tract DefenseAntibacterial Protection1 in 1 BOXTABLET17
49973-011-24Azo Urinary Tract DefenseAntibacterial Protection1 in 1 BOXTABLET17
49973-011-24Azo Urinary Tract DefenseAntibacterial Protection24 in 1 BLISTER PACKTABLET247
49973-011-48Azo Urinary Tract DefenseAntibacterial Protection2 in 1 BOXTABLET27
49973-011-48Azo Urinary Tract DefenseAntibacterial Protection24 in 1 BLISTER PACKTABLET247

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
METHENAMINEACTIVE INGREDIENTJ50OIX95QVAZO URINARY TRACT DEFENSE ANTIBACTERIAL PROTECTION (METHENAMINE, SODIUM SALICYLATE) TABLET [I-HEALTH, INC.]1
SODIUM SALICYLATEACTIVE INGREDIENTWIQ1H85SYPAZO URINARY TRACT DEFENSE ANTIBACTERIAL PROTECTION (METHENAMINE, SODIUM SALICYLATE) TABLET [I-HEALTH, INC.]1
METHENAMINEACTIVE MOIETYJ50OIX95QVAZO URINARY TRACT DEFENSE ANTIBACTERIAL PROTECTION (METHENAMINE, SODIUM SALICYLATE) TABLET [I-HEALTH, INC.]1
SALICYLIC ACIDACTIVE MOIETYO414PZ4LPZAZO URINARY TRACT DEFENSE ANTIBACTERIAL PROTECTION (METHENAMINE, SODIUM SALICYLATE) TABLET [I-HEALTH, INC.]1
BENZOIC ACIDINACTIVE INGREDIENT8SKN0B0MIMAZO URINARY TRACT DEFENSE ANTIBACTERIAL PROTECTION (METHENAMINE, SODIUM SALICYLATE) TABLET [I-HEALTH, INC.]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48AZO URINARY TRACT DEFENSE ANTIBACTERIAL PROTECTION (METHENAMINE, SODIUM SALICYLATE) TABLET [I-HEALTH, INC.]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAAZO URINARY TRACT DEFENSE ANTIBACTERIAL PROTECTION (METHENAMINE, SODIUM SALICYLATE) TABLET [I-HEALTH, INC.]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8AZO URINARY TRACT DEFENSE ANTIBACTERIAL PROTECTION (METHENAMINE, SODIUM SALICYLATE) TABLET [I-HEALTH, INC.]1
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357AZO URINARY TRACT DEFENSE ANTIBACTERIAL PROTECTION (METHENAMINE, SODIUM SALICYLATE) TABLET [I-HEALTH, INC.]1
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PAZO URINARY TRACT DEFENSE ANTIBACTERIAL PROTECTION (METHENAMINE, SODIUM SALICYLATE) TABLET [I-HEALTH, INC.]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOAZO URINARY TRACT DEFENSE ANTIBACTERIAL PROTECTION (METHENAMINE, SODIUM SALICYLATE) TABLET [I-HEALTH, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30AZO URINARY TRACT DEFENSE ANTIBACTERIAL PROTECTION (METHENAMINE, SODIUM SALICYLATE) TABLET [I-HEALTH, INC.]1
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AINACTIVE INGREDIENTNX76LV5T8JAZO URINARY TRACT DEFENSE ANTIBACTERIAL PROTECTION (METHENAMINE, SODIUM SALICYLATE) TABLET [I-HEALTH, INC.]1
POWDERED CELLULOSEINACTIVE INGREDIENTSMD1X3XO9MAZO URINARY TRACT DEFENSE ANTIBACTERIAL PROTECTION (METHENAMINE, SODIUM SALICYLATE) TABLET [I-HEALTH, INC.]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4AZO URINARY TRACT DEFENSE ANTIBACTERIAL PROTECTION (METHENAMINE, SODIUM SALICYLATE) TABLET [I-HEALTH, INC.]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APAZO URINARY TRACT DEFENSE ANTIBACTERIAL PROTECTION (METHENAMINE, SODIUM SALICYLATE) TABLET [I-HEALTH, INC.]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPAZO URINARY TRACT DEFENSE ANTIBACTERIAL PROTECTION (METHENAMINE, SODIUM SALICYLATE) TABLET [I-HEALTH, INC.]1
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UMAZO URINARY TRACT DEFENSE ANTIBACTERIAL PROTECTION (METHENAMINE, SODIUM SALICYLATE) TABLET [I-HEALTH, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49973-011AZO URINARY TRACT DEFENSE ANTIBACTERIAL PROTECTION (METHENAMINE, SODIUM SALICYLATE) TABLET [I-HEALTH, INC.]5Current NDC, Legacy NDC, 7 package rows20201218_ba13a608-e4c5-4465-8be8-be0fd1fd46ae.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1721434Azo Urinary Tract Defense 162 MG / 162.5 MG Oral TabletPSNba13a608-e4c5-4465-8be8-be0fd1fd46ae7
1489932methenamine 162 MG / sodium salicylate 162.5 MG Oral TabletPSNba13a608-e4c5-4465-8be8-be0fd1fd46ae7
1721434methenamine 162 MG / sodium salicylate 162.5 MG Oral Tablet [Azo Urinary Tract Defense]SBDba13a608-e4c5-4465-8be8-be0fd1fd46ae7
1489932methenamine 162 MG / sodium salicylate 162.5 MG Oral TabletSCDba13a608-e4c5-4465-8be8-be0fd1fd46ae7
1721434Azo Urinary Tract Defense (methenamine 162 MG / sodium salicylate 162.5 MG) Oral TabletSYba13a608-e4c5-4465-8be8-be0fd1fd46ae7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49973-011-04499730011044 in 1 POUCHHistorical
49973-011-18499730011181 BLISTER PACK in 1 BOX (49973-011-18) / 18 TABLET in 1 BLISTER PACK1 blister pack2018-04-230000-00-00NoNoCurrent
49973-011-24499730011241 BLISTER PACK in 1 BOX (49973-011-24) / 24 TABLET in 1 BLISTER PACK1 blister pack2016-03-010000-00-00NoNoCurrent
49973-011-48499730011482 BLISTER PACK in 1 BOX (49973-011-48) / 24 TABLET in 1 BLISTER PACK2 blister pack2025-12-15NoNoHistorical