FDA.reportPublic FDA data

Rugby Phenazopyridine HCl Urinary Tract Analgesic

Product NDC
0536-1411
11-digit product format
005361411
Labeler code
0536
Product ID
0536-1411_6d75180f-33bf-41dc-82c1-7c193aac68c4
Type
HUMAN OTC DRUG
Nonproprietary name
PHENAZOPYRIDINE HYDROCHLORIDE
Dosage form
TABLET
Route
ORAL
Labeler
Rugby Laboratories
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2023-12-07
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
Rugby Phenazopyridine HCl Urinary Tract AnalgesicPHENAZOPYRIDINE HYDROCHLORIDERugby Laboratories7519c0ac-586a-4aa5-a7fe-0e10cbc4bfc62024-12-18WarningsExact identifier

Warnings cross-check#

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

warnings

Warning Do not exceed recommended dosage Do not use if you have Glucose-6-Phosphate Dehydrogenase (G6PD) deficiency unless approved by your physician

Additional Listing Data#

Finished product
Yes
Brand name base
Rugby Phenazopyridine HCl Urinary Tract Analgesic
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
0536-1411-07Rugby Phenazopyridine HCl Urinary Tract Analgesic30 in 1 BLISTER PACKTABLET302
0536-1411-07Rugby Phenazopyridine HCl Urinary Tract Analgesic1 in 1 CARTONTABLET12

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0536-1411-07EA - Each0536-1411cebab2d4-4fbb-4479-ade0-8c20c6fe5efc12024-04-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0536-1411RUGBY PHENAZOPYRIDINE HCL URINARY TRACT ANALGESIC (PHENAZOPYRIDINE HYDROCHLORIDE) TABLET [RUGBY LABORATORIES]2Current NDC, 2 package rows20241220_7519c0ac-586a-4aa5-a7fe-0e10cbc4bfc6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1094126phenazopyridine HCl 95 MG Oral TabletPSN7519c0ac-586a-4aa5-a7fe-0e10cbc4bfc62
1094126phenazopyridine hydrochloride 95 MG Oral TabletSCD7519c0ac-586a-4aa5-a7fe-0e10cbc4bfc62
1094126phenazopyridine HCl 95 MG Oral TabletSY7519c0ac-586a-4aa5-a7fe-0e10cbc4bfc62

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0536-1411-07005361411071 BLISTER PACK in 1 CARTON (0536-1411-07) / 30 TABLET in 1 BLISTER PACK1 blister pack2023-12-07NoNoCurrent