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#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage49973-30149973-301-30DDiscontinued by firm2026-08-17
excluded packagepackage49973-30149973-301-32DDiscontinued by firm2026-08-17

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 · 24 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Package NDC, Snapshot table
Captured / source datePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-0549973-301-32d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-0549973-301-30d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-2649973-301-32f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-2649973-301-30f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-3149973-301-322ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-3149973-301-302ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-2849973-301-32a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-2849973-301-30a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-2149973-301-32cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-2149973-301-30cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-1049973-301-32cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-1049973-301-30cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-3149973-301-32302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-3149973-301-30302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-2049973-301-32ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-2049973-301-30ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-1049973-301-320efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-1049973-301-300efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-0849973-301-32ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-0849973-301-30ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-0349973-301-32367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-0349973-301-30367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-0949973-301-32557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-0949973-301-30557ba5c1ecfa…9c80585c8c6e…

Additional Listing Data#

Finished product
Yes
Brand name base
AZO
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PHENAZOPYRIDINE HYDROCHLORIDE95 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
1094126Internal RxNorm lookup
1094192Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
3d0298b7-eaec-488b-9cab-19af4614ff53Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49973-301-30AZO15 in 1 BOXTABLET158
49973-301-30AZO2 in 1 BLISTER PACKTABLET28
49973-301-31AZO15 in 1 BOXTABLET158
49973-301-31AZO2 in 1 BLISTER PACKTABLET28
49973-301-32AZO1 in 1 BOXTABLET18
49973-301-32AZO18 in 1 BLISTER PACKTABLET188

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49973-301-31EA - Each49973-301188f7be8-bc47-4830-b185-86c345159e8612019-12-10

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Phenazopyridine HydrochlorideACTIVE INGREDIENT0EWG668W17AZO (URINARY PAIN RELIEF) TABLET [I-HEALTH, INC.]3
PhenazopyridineACTIVE MOIETYK2J09EMJ52AZO (URINARY PAIN RELIEF) TABLET [I-HEALTH, INC.]3
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZAZO (URINARY PAIN RELIEF) TABLET [I-HEALTH, INC.]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UAZO (URINARY PAIN RELIEF) TABLET [I-HEALTH, INC.]3
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48AZO (URINARY PAIN RELIEF) TABLET [I-HEALTH, INC.]3
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOAZO (URINARY PAIN RELIEF) TABLET [I-HEALTH, INC.]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30AZO (URINARY PAIN RELIEF) TABLET [I-HEALTH, INC.]3
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AAZO (URINARY PAIN RELIEF) TABLET [I-HEALTH, INC.]3
POVIDONEINACTIVE INGREDIENTFZ989GH94EAZO (URINARY PAIN RELIEF) TABLET [I-HEALTH, INC.]3
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJAZO (URINARY PAIN RELIEF) TABLET [I-HEALTH, INC.]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49973-301AZO (URINARY PAIN RELIEF) TABLET [I-HEALTH, INC.]7Current NDC, Legacy NDC, 6 package rows20201218_3d0298b7-eaec-488b-9cab-19af4614ff53.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
AZOURINARY PAIN RELIEFi-Health, Inc.3d0298b7-eaec-488b-9cab-19af4614ff532026-01-05WarningsExact identifier
ndc (product): 49973-301

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1094192Azo Urinary Pain Relief 95 MG Oral TabletPSN3d0298b7-eaec-488b-9cab-19af4614ff538
1094126phenazopyridine HCl 95 MG Oral TabletPSN3d0298b7-eaec-488b-9cab-19af4614ff538
1094192phenazopyridine hydrochloride 95 MG Oral Tablet [Azo Urinary Pain Relief]SBD3d0298b7-eaec-488b-9cab-19af4614ff538
1094126phenazopyridine hydrochloride 95 MG Oral TabletSCD3d0298b7-eaec-488b-9cab-19af4614ff538
1094192Azo Urinary Pain Relief 95 MG Oral TabletSY3d0298b7-eaec-488b-9cab-19af4614ff538
1094126phenazopyridine HCl 95 MG Oral TabletSY3d0298b7-eaec-488b-9cab-19af4614ff538

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49973-301-304997303013015 in 1 BOXHistorical
49973-301-314997303013115 BLISTER PACK in 1 BOX (49973-301-31) / 2 TABLET in 1 BLISTER PACK15 blister pack2012-05-240000-00-00NoNoCurrent
49973-301-32499730301321 in 1 BOXHistorical