Home NDC 49973-301 AZO
Product NDC 49973-301
11-digit product format 499730301
Labeler code 49973
Product ID 49973-301_47a4fa0f-9c93-6286-e063-6394a90aa070
Type HUMAN OTC DRUG
Nonproprietary name Urinary Pain Relief
Dosage form TABLET
Route ORAL
Labeler i-Health, Inc.
Marketing category UNAPPROVED DRUG OTHER
Marketing start 2012-05-24
Substance PHENAZOPYRIDINE HYDROCHLORIDE
Active strength 95 mg/1
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes NDC auxiliary status# Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status.
Dataset, Scope, Product NDC table Dataset Scope Product NDC Package NDC Code Status Reporting period Source date excluded package package 49973-301 49973-301-30 D Discontinued by firm 2026-07-31 excluded package package 49973-301 49973-301-32 D Discontinued by firm 2026-07-31
openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join AZO URINARY PAIN RELIEF i-Health, Inc. 3d0298b7-eaec-488b-9cab-19af4614ff53 2026-01-05 Warnings Exact identifier
Warnings cross-check# openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
warnings Warnings Please read insert for important precautions. Ask a doctor before use if you have kidney disease allergies to foods, preservatives or dyes had a hypersensitive reaction to Phenazopyridine Hydrochloride. Caution: Do not use this product if you have Glucose-6-Phosphate Dehydrogenase (G6PD) deficiency unless approved by your physician. When using this product stomach upset may occur, taking this product with or after meals may reduce stomach upset. your urine will become reddish-orange in color. This is not harmful, but care should be taken to avoid staining clothing or other items. Stop use and ask doctor your symptoms last for more than 2 days you suspect you are having an adverse reaction to the medication.
Additional Listing Data#
Finished product Yes
Brand name base AZO
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength PHENAZOPYRIDINE HYDROCHLORIDE 95 mg/1
Harmonized Identifiers# Field, Values table Field Values Unii 0EWG668W17 Rxcui 1094126, 1094192
DailyMed Package Descriptions# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded Phenazopyridine Hydrochloride ACTIVE INGREDIENT 0EWG668W17 AZO (URINARY PAIN RELIEF) TABLET [I-HEALTH, INC.] 3 Phenazopyridine ACTIVE MOIETY K2J09EMJ52 AZO (URINARY PAIN RELIEF) TABLET [I-HEALTH, INC.] 3 CARNAUBA WAX INACTIVE INGREDIENT R12CBM0EIZ AZO (URINARY PAIN RELIEF) TABLET [I-HEALTH, INC.] 3 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U AZO (URINARY PAIN RELIEF) TABLET [I-HEALTH, INC.] 3 CROSCARMELLOSE SODIUM INACTIVE INGREDIENT M28OL1HH48 AZO (URINARY PAIN RELIEF) TABLET [I-HEALTH, INC.] 3 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO AZO (URINARY PAIN RELIEF) TABLET [I-HEALTH, INC.] 3 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 AZO (URINARY PAIN RELIEF) TABLET [I-HEALTH, INC.] 3 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A AZO (URINARY PAIN RELIEF) TABLET [I-HEALTH, INC.] 3 POVIDONE INACTIVE INGREDIENT FZ989GH94E AZO (URINARY PAIN RELIEF) TABLET [I-HEALTH, INC.] 3 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ AZO (URINARY PAIN RELIEF) TABLET [I-HEALTH, INC.] 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 49973-301 AZO (URINARY PAIN RELIEF) TABLET [I-HEALTH, INC.] 7 Current NDC, Legacy NDC, 6 package rows 20201218_3d0298b7-eaec-488b-9cab-19af4614ff53.zip
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 49973-301-30 49973030130 15 in 1 BOX Historical 49973-301-31 49973030131 15 BLISTER PACK in 1 BOX (49973-301-31) / 2 TABLET in 1 BLISTER PACK 15 blister pack 2012-05-24 0000-00-00 No No Current 49973-301-32 49973030132 1 in 1 BOX Historical