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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage49973-01149973-011-04DDiscontinued by firm2026-10-05

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…

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
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 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
1721434Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
ba13a608-e4c5-4465-8be8-be0fd1fd46aeAvailable on FDA.report

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

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
Azo Urinary Tract Defense Antibacterial ProtectionMETHENAMINE, SODIUM SALICYLATEi-Health, Inc.ba13a608-e4c5-4465-8be8-be0fd1fd46ae2025-11-25WarningsExact identifier
ndc (product): 49973-011

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 pack2025-12-15NoNoCurrent