Home NDC 80513-517 Maximum Strength Urinary Pain Relief
Product NDC 80513-517
11-digit product format 805130517
Labeler code 80513
Product ID 80513-517_1b87f423-20e1-743e-e063-6294a90aaa03
Type HUMAN OTC DRUG
Nonproprietary name Phenazopyridine Hydrochloride
Dosage form TABLET
Route ORAL
Labeler Advanced Rx LLC
Marketing category UNAPPROVED DRUG OTHER
Marketing start 2024-05-01
Substance PHENAZOPYRIDINE HYDROCHLORIDE
Active strength 99.5 mg/1
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Maximum Strength Urinary Pain Relief
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength PHENAZOPYRIDINE HYDROCHLORIDE 99.5 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 0EWG668W17 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1094147 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 80513-517-72 Maximum Strength Urinary Pain Relief 72 in 1 BOTTLE TABLET 72 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 80513-517 MAXIMUM STRENGTH URINARY PAIN RELIEF (PHENAZOPYRIDINE HYDROCHLORIDE) TABLET [ADVANCED RX LLC] 1 Current NDC, 1 package rows 20240625_a10464cf-36b2-460f-b31c-2e0edee3e4cf.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 80513-517-72 80513051772 72 TABLET in 1 BOTTLE (80513-517-72) 72 tablet 2024-05-01 No No Current