FDA.reportPublic FDA data

Leader Urinary Pain Relief

Product NDC
70000-0243
11-digit product format
700000243
Labeler code
70000
Product ID
70000-0243_941e2a47-36d1-4ebd-938e-759b3ea9e1e4
Type
HUMAN OTC DRUG
Nonproprietary name
PHENAZOPYRIDINE HYDROCHLORIDE
Dosage form
TABLET
Route
ORAL
Labeler
Cardinal Health
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2013-07-01
Substance
PHENAZOPYRIDINE HYDROCHLORIDE
Active strength
95 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 Urinary Pain ReliefPHENAZOPYRIDINE HYDROCHLORIDECardinal Healthd1d1d4de-ab20-40fa-a6cf-53d805c7ecb32024-12-18WarningsExact identifier

Warnings cross-check#

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

warnings

Warning Do not exceed recommended dosage

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PHENAZOPYRIDINE HYDROCHLORIDE95 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii0EWG668W17
Rxcui1094126

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70000-0243-1Leader Urinary Pain Relief30 in 1 BLISTER PACKTABLET305
70000-0243-1Leader Urinary Pain Relief1 in 1 CARTONTABLET15

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70000-0243-1EA - Each70000-02432d1fee72-a2ff-440f-b4a6-be0fc3d922d512017-12-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70000-0243LEADER URINARY PAIN RELIEF (PHENAZOPYRIDINE HYDROCHLORIDE) TABLET [CARDINAL HEALTH]5Current NDC, Legacy NDC, 2 package rows20241220_d1d1d4de-ab20-40fa-a6cf-53d805c7ecb3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1094126phenazopyridine HCl 95 MG Oral TabletPSNd1d1d4de-ab20-40fa-a6cf-53d805c7ecb35
1094126phenazopyridine hydrochloride 95 MG Oral TabletSCDd1d1d4de-ab20-40fa-a6cf-53d805c7ecb35
1094126phenazopyridine HCl 95 MG Oral TabletSYd1d1d4de-ab20-40fa-a6cf-53d805c7ecb35

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70000-0243-1700000243011 BLISTER PACK in 1 CARTON (70000-0243-1) / 30 TABLET in 1 BLISTER PACK1 blister pack2017-02-010000-00-00NoNoCurrent