FDA.reportPublic FDA data

Leader Maximum Strength Urinary Pain Relief

Product NDC
70000-0523
11-digit product format
700000523
Labeler code
70000
Product ID
70000-0523_0c6765cb-4ade-4790-8ea5-311e94fcf4d3
Type
HUMAN OTC DRUG
Nonproprietary name
PHENAZOPYRIDINE HYDROCHLORIDE
Dosage form
TABLET
Route
ORAL
Labeler
Cardinal Health
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2019-10-10
Substance
PHENAZOPYRIDINE HYDROCHLORIDE
Active strength
99.5 mg/1
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

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
Leader Maximum Strength Urinary Pain ReliefPHENAZOPYRIDINE HYDROCHLORIDECardinal Health4ece7c89-b01b-48b5-8736-2253b14fa5512024-12-18WarningsExact identifier

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

warnings

Warnings Do not exceed recommended dosage

Additional Listing Data#

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

Active Ingredients#

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

Harmonized Identifiers#

Field, Values table
FieldValues
Unii0EWG668W17
Rxcui1094147

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70000-0523-1Leader Maximum Strength Urinary Pain Relief12 in 1 BLISTER PACKTABLET125
70000-0523-1Leader Maximum Strength Urinary Pain Relief1 in 1 CARTONTABLET15

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70000-0523-1EA - Each70000-052353e923c0-3792-40d1-bb45-ab009984ebc412020-07-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70000-0523LEADER MAXIMUM STRENGTH URINARY PAIN RELIEF (PHENAZOPYRIDINE HYDROCHLORIDE) TABLET [CARDINAL HEALTH]5Current NDC, Legacy NDC, 2 package rows20241220_4ece7c89-b01b-48b5-8736-2253b14fa551.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1094147phenazopyridine HCl 99.5 MG Oral TabletPSN4ece7c89-b01b-48b5-8736-2253b14fa5515
1094147phenazopyridine hydrochloride 99.5 MG Oral TabletSCD4ece7c89-b01b-48b5-8736-2253b14fa5515
1094147phenazopyridine HCl 99.5 MG Oral TabletSY4ece7c89-b01b-48b5-8736-2253b14fa5515

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70000-0523-1700000523011 BLISTER PACK in 1 CARTON (70000-0523-1) / 12 TABLET in 1 BLISTER PACK1 blister pack2019-10-100000-00-00NoNoCurrent