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

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 pouch2023-06-15NoNoHistorical
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 pack2025-12-08NoNoHistorical
49973-247-964997302479648 BLISTER PACK in 1 BOX (49973-247-96) > 2 TABLET in 1 BLISTER PACK48 blister pack2019-02-220000-00-00NoNoCurrent