FDA.reportPublic FDA data

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

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 Identifiers#

Field, Values table
FieldValues
Unii0EWG668W17
Rxcui1094126, 1094192

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

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