FDA.reportPublic FDA data

AZO Urinary Pain Relief

Product NDC
49973-247
Requested package NDC
49973-247-06
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

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 UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
0EWG668W17Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1094147Internal RxNorm lookup
2048946Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
b4874fe2-d98b-4b5c-baad-d75070947842Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Related label table
NDCRelated label
49973-247-06AZO Urinary Pain Relief Maximum Strength
49973-247-12AZO Urinary Pain Relief Maximum Strength
49973-247-24AZO Urinary Pain Relief Maximum Strength
49973-247-96AZO 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

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 Pain Relief Maximum StrengthPHENAZOPYRIDINE HYDROCHLORIDEi-Health, Inc.b4874fe2-d98b-4b5c-baad-d750709478422025-11-17WarningsExact identifier
ndc (package): 49973-247-06
ndc (product): 49973-247
ndc11 (package): 49973024706

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 startSampleExclude flagStatus
49973-247-06499730247063 POUCH in 1 BOX (49973-247-06) / 2 TABLET in 1 POUCH3 pouch2023-06-15NoNoCurrent