Home NDC 49973-011 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
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 date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…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 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 1721434 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 49973-011-04 Azo Urinary Tract DefenseAntibacterial Protection 4 in 1 POUCH TABLET 4 7 49973-011-18 Azo Urinary Tract DefenseAntibacterial Protection 18 in 1 BLISTER PACK TABLET 18 7 49973-011-18 Azo Urinary Tract DefenseAntibacterial Protection 1 in 1 BOX TABLET 1 7 49973-011-24 Azo Urinary Tract DefenseAntibacterial Protection 1 in 1 BOX TABLET 1 7 49973-011-24 Azo Urinary Tract DefenseAntibacterial Protection 24 in 1 BLISTER PACK TABLET 24 7 49973-011-48 Azo Urinary Tract DefenseAntibacterial Protection 2 in 1 BOX TABLET 2 7 49973-011-48 Azo Urinary Tract DefenseAntibacterial Protection 24 in 1 BLISTER PACK TABLET 24 7
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded METHENAMINE ACTIVE INGREDIENT J50OIX95QV AZO URINARY TRACT DEFENSE ANTIBACTERIAL PROTECTION (METHENAMINE, SODIUM SALICYLATE) TABLET [I-HEALTH, INC.] 1 SODIUM SALICYLATE ACTIVE INGREDIENT WIQ1H85SYP AZO URINARY TRACT DEFENSE ANTIBACTERIAL PROTECTION (METHENAMINE, SODIUM SALICYLATE) TABLET [I-HEALTH, INC.] 1 METHENAMINE ACTIVE MOIETY J50OIX95QV AZO URINARY TRACT DEFENSE ANTIBACTERIAL PROTECTION (METHENAMINE, SODIUM SALICYLATE) TABLET [I-HEALTH, INC.] 1 SALICYLIC ACID ACTIVE MOIETY O414PZ4LPZ AZO URINARY TRACT DEFENSE ANTIBACTERIAL PROTECTION (METHENAMINE, SODIUM SALICYLATE) TABLET [I-HEALTH, INC.] 1 BENZOIC ACID INACTIVE INGREDIENT 8SKN0B0MIM AZO URINARY TRACT DEFENSE ANTIBACTERIAL PROTECTION (METHENAMINE, SODIUM SALICYLATE) TABLET [I-HEALTH, INC.] 1 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 AZO URINARY TRACT DEFENSE ANTIBACTERIAL PROTECTION (METHENAMINE, SODIUM SALICYLATE) TABLET [I-HEALTH, INC.] 1 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA AZO URINARY TRACT DEFENSE ANTIBACTERIAL PROTECTION (METHENAMINE, SODIUM SALICYLATE) TABLET [I-HEALTH, INC.] 1 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 AZO URINARY TRACT DEFENSE ANTIBACTERIAL PROTECTION (METHENAMINE, SODIUM SALICYLATE) TABLET [I-HEALTH, INC.] 1 FERROSOFERRIC OXIDE INACTIVE INGREDIENT XM0M87F357 AZO URINARY TRACT DEFENSE ANTIBACTERIAL PROTECTION (METHENAMINE, SODIUM SALICYLATE) TABLET [I-HEALTH, INC.] 1 HYDROXYPROPYL CELLULOSE (TYPE H) INACTIVE INGREDIENT RFW2ET671P AZO URINARY TRACT DEFENSE ANTIBACTERIAL PROTECTION (METHENAMINE, SODIUM SALICYLATE) TABLET [I-HEALTH, INC.] 1 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO AZO URINARY TRACT DEFENSE ANTIBACTERIAL PROTECTION (METHENAMINE, SODIUM SALICYLATE) TABLET [I-HEALTH, INC.] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 AZO URINARY TRACT DEFENSE ANTIBACTERIAL PROTECTION (METHENAMINE, SODIUM SALICYLATE) TABLET [I-HEALTH, INC.] 1 METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A INACTIVE INGREDIENT NX76LV5T8J AZO URINARY TRACT DEFENSE ANTIBACTERIAL PROTECTION (METHENAMINE, SODIUM SALICYLATE) TABLET [I-HEALTH, INC.] 1 POWDERED CELLULOSE INACTIVE INGREDIENT SMD1X3XO9M AZO URINARY TRACT DEFENSE ANTIBACTERIAL PROTECTION (METHENAMINE, SODIUM SALICYLATE) TABLET [I-HEALTH, INC.] 1 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 AZO URINARY TRACT DEFENSE ANTIBACTERIAL PROTECTION (METHENAMINE, SODIUM SALICYLATE) TABLET [I-HEALTH, INC.] 1 STEARIC ACID INACTIVE INGREDIENT 4ELV7Z65AP AZO URINARY TRACT DEFENSE ANTIBACTERIAL PROTECTION (METHENAMINE, SODIUM SALICYLATE) TABLET [I-HEALTH, INC.] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP AZO URINARY TRACT DEFENSE ANTIBACTERIAL PROTECTION (METHENAMINE, SODIUM SALICYLATE) TABLET [I-HEALTH, INC.] 1 TRIETHYL CITRATE INACTIVE INGREDIENT 8Z96QXD6UM AZO URINARY TRACT DEFENSE ANTIBACTERIAL PROTECTION (METHENAMINE, SODIUM SALICYLATE) TABLET [I-HEALTH, INC.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 49973-011 AZO URINARY TRACT DEFENSE ANTIBACTERIAL PROTECTION (METHENAMINE, SODIUM SALICYLATE) TABLET [I-HEALTH, INC.] 5 Current NDC, Legacy NDC, 7 package rows 20201218_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.
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 49973-011-04 49973001104 4 in 1 POUCH Historical 49973-011-18 49973001118 1 BLISTER PACK in 1 BOX (49973-011-18) / 18 TABLET in 1 BLISTER PACK 1 blister pack 2018-04-23 0000-00-00 No No Current 49973-011-24 49973001124 1 BLISTER PACK in 1 BOX (49973-011-24) / 24 TABLET in 1 BLISTER PACK 1 blister pack 2016-03-01 0000-00-00 No No Current 49973-011-48 49973001148 2 BLISTER PACK in 1 BOX (49973-011-48) / 24 TABLET in 1 BLISTER PACK 2 blister pack 2025-12-15 No No Current