Home NDC 68788-7778-3 Preferred Maximum Strength Urinary Pain Relief
Product NDC 68788-7778
Requested package NDC 68788-7778-3
11-digit product format 687887778
Labeler code 68788
Product ID 68788-7778_0fa8638c-e3e0-4bbf-9101-842e5d8736d6
Type HUMAN OTC DRUG
Nonproprietary name PHENAZOPYRIDINE HYDROCHLORIDE
Dosage form TABLET
Route ORAL
Labeler Preferred Pharmaceuticals Inc.
Marketing category UNAPPROVED DRUG OTHER
Marketing start 2026-06-04
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 Preferred 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.
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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 68788-7778-3 68788777803 1 BLISTER PACK in 1 CARTON (68788-7778-3) / 12 TABLET in 1 BLISTER PACK 1 blister pack 2026-06-04 No No Current