FDA.reportPublic FDA data

Leader Maximum Strength Urinary Pain Relief

Product NDC
70000-0241
11-digit product format
700000241
Labeler code
70000
Product ID
70000-0241_16326945-97af-4f03-ab90-67614ed345a8
Type
HUMAN OTC DRUG
Nonproprietary name
PHENAZOPYRIDINE HYDROCHLORIDE
Dosage form
TABLET
Route
ORAL
Labeler
Cardinal Health
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2017-02-01
Marketing end
0000-00-00
Substance
PHENAZOPYRIDINE HYDROCHLORIDE
Active strength
98 mg/1
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

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 productproduct70000-0241DDiscontinued by firm2026-11-10
excluded packagepackage70000-024170000-0241-1DDiscontinued by firm2026-11-10

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70000-0241-1Leader Maximum Strength Urinary Pain Relief1 in 1 CARTONTABLET11
70000-0241-1Leader Maximum Strength Urinary Pain Relief12 in 1 BLISTER PACKTABLET121

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70000-0241-1EA - Each70000-0241e734d589-5050-450f-9b0b-5a9aa91b710c12017-12-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70000-0241LEADER MAXIMUM STRENGTH URINARY PAIN RELIEF (PHENAZOPYRIDINE HYDROCHLORIDE) TABLET [CARDINAL HEALTH]1Legacy NDC, 2 package rows20170303_32624e4e-dd30-49f4-8f3c-baff9f83eb28.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1094357phenazopyridine HCl 97.5 MG Oral TabletPSN32624e4e-dd30-49f4-8f3c-baff9f83eb281
1094357phenazopyridine hydrochloride 97.5 MG Oral TabletSCD32624e4e-dd30-49f4-8f3c-baff9f83eb281

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70000-0241-1700000241011 BLISTER PACK in 1 CARTON (70000-0241-1) > 12 TABLET in 1 BLISTER PACK1 blister pack2017-02-010000-00-00NoNoCurrent