FDA.reportPublic FDA data

AZO Urinary Pain Relief

Product NDC
49973-247
11-digit product format
499730247
Labeler code
49973
Product ID
49973-247_43d1e43f-1475-87b0-e063-6294a90a67ca
Type
HUMAN OTC DRUG
Nonproprietary name
Phenazopyridine Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
i-Health, Inc.
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2018-07-02
Substance
PHENAZOPYRIDINE HYDROCHLORIDE
Active strength
99.5 mg/1
NDC exclude flag
No
Listing certified through
2026-12-31
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
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage49973-24749973-247-96DDiscontinued by firm2026-07-31

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AZO Urinary Pain Relief Maximum StrengthPHENAZOPYRIDINE HYDROCHLORIDEi-Health, Inc.b4874fe2-d98b-4b5c-baad-d750709478422025-11-17WarningsExact 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 Do not use 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 if your symptoms last for more than 2 days you suspect you are having an adverse reaction to the medication. If pregnant or breastfeeding, ask a professional before use. A pregnancy test and consultation with a health professional if pregnancy is confirmed is recommended prior to use. Keep out of reach of children. In case of an overdose, get medical help or contact a Poison Control Center right away.

Additional Listing Data#

Finished product
Yes
Brand name base
AZO Urinary Pain Relief
Brand name suffix
Maximum Strength
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PHENAZOPYRIDINE HYDROCHLORIDE99.5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii0EWG668W17
Rxcui1094147, 2048946

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
49973-247-062024-01-30C16284748780-11030e365-69af-111a-e063-dadaa90a10e2AZO Urinary Pain Relief Maximum Strength
49973-247-122024-01-30C16284748780-11030e365-69af-111a-e063-dadaa90a10e2AZO Urinary Pain Relief Maximum Strength
49973-247-242024-01-30C16284748780-11030e365-69af-111a-e063-dadaa90a10e2AZO Urinary Pain Relief Maximum Strength
49973-247-962024-01-30C16284748780-11030e365-69af-111a-e063-dadaa90a10e2AZO Urinary Pain Relief Maximum Strength

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49973-247-06AZO Urinary Pain ReliefMaximum Strength3 in 1 BOXTABLET311
49973-247-06AZO Urinary Pain ReliefMaximum Strength2 in 1 POUCHTABLET211
49973-247-12AZO Urinary Pain ReliefMaximum Strength6 in 1 BOXTABLET611
49973-247-12AZO Urinary Pain ReliefMaximum Strength2 in 1 BLISTER PACKTABLET211
49973-247-24AZO Urinary Pain ReliefMaximum Strength2 in 1 BLISTER PACKTABLET211
49973-247-24AZO Urinary Pain ReliefMaximum Strength12 in 1 BOXTABLET1211
49973-247-48AZO Urinary Pain ReliefMaximum Strength2 in 1 BLISTER PACKTABLET211
49973-247-48AZO Urinary Pain ReliefMaximum Strength24 in 1 BOXTABLET2411
49973-247-96AZO Urinary Pain ReliefMaximum Strength48 in 1 BOXTABLET4811
49973-247-96AZO Urinary Pain ReliefMaximum Strength2 in 1 BLISTER PACKTABLET211

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49973-247-96EA - Each49973-24715446a27-bc51-4547-93c7-62d473dedcdd12019-05-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49973-247AZO URINARY PAIN RELIEF MAXIMUM STRENGTH (PHENAZOPYRIDINE HYDROCHLORIDE) TABLET [I-HEALTH, INC.]10Current NDC, Legacy NDC, 10 package rows20231109_b4874fe2-d98b-4b5c-baad-d75070947842.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2048946AZO Urinary Pain Relief 99.5 MG Oral TabletPSNb4874fe2-d98b-4b5c-baad-d7507094784211
1094147phenazopyridine HCl 99.5 MG Oral TabletPSNb4874fe2-d98b-4b5c-baad-d7507094784211
2048946phenazopyridine hydrochloride 99.5 MG Oral Tablet [Azo Urinary Pain Relief]SBDb4874fe2-d98b-4b5c-baad-d7507094784211
1094147phenazopyridine hydrochloride 99.5 MG Oral TabletSCDb4874fe2-d98b-4b5c-baad-d7507094784211
2048946Azo Urinary Pain Relief 99.5 MG Oral TabletSYb4874fe2-d98b-4b5c-baad-d7507094784211
1094147phenazopyridine HCl 99.5 MG Oral TabletSYb4874fe2-d98b-4b5c-baad-d7507094784211

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49973-247-06499730247063 POUCH in 1 BOX (49973-247-06) / 2 TABLET in 1 POUCH3 pouch2023-06-15NoNoCurrent
49973-247-12499730247126 BLISTER PACK in 1 BOX (49973-247-12) / 2 TABLET in 1 BLISTER PACK6 blister pack2018-07-020000-00-00NoNoCurrent
49973-247-244997302472412 BLISTER PACK in 1 BOX (49973-247-24) / 2 TABLET in 1 BLISTER PACK12 blister pack2018-07-020000-00-00NoNoCurrent
49973-247-484997302474824 BLISTER PACK in 1 BOX (49973-247-48) / 2 TABLET in 1 BLISTER PACK24 blister pack2025-12-08NoNoCurrent
49973-247-964997302479648 BLISTER PACK in 1 BOX (49973-247-96) > 2 TABLET in 1 BLISTER PACK48 blister pack2019-02-220000-00-00NoNoCurrent