Home NDC 58657-458-90 Uro-458
Product NDC 58657-458
Requested package NDC 58657-458-90
11-digit product format 586570458
Labeler code 58657
Product ID 58657-458_ed255abb-0299-3cfb-e053-2a95a90a271f
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Methenamine, Sodium Phosphate, Monobasic, Anhydrous, Phenyl Salicylate, Methylene Blue and Hyoscyamine Sulfate
Dosage form TABLET
Route ORAL
Labeler Method Pharmaceuticals, LLC
Marketing category UNAPPROVED DRUG OTHER
Marketing start 2016-06-17
Marketing end 0000-00-00
Substance HYOSCYAMINE SULFATE; METHENAMINE; METHYLENE BLUE; PHENYL SALICYLATE; SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS
Active strength 0 mg/1; mg/1; mg/1; mg/1; mg/1
Pharmacologic classes Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC], Oxidation-Reduction Activity [MoA], Oxidation-Reduction Agent [EPC]
NDC exclude flag No
Listing certified through 2023-12-31
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed RxNorm Mappings# RxCUI, RxNorm string, TTY table RxCUI RxNorm string TTY DailyMed SPL version 1048336 methenamine 81 MG / sodium phosphate, monobasic 40.8 MG / phenyl salicylate 32.4 MG / methylene blue 10.8 MG / hyoscyamine sulfate 0.12 MG Oral Tablet PSN 6cbeb7be-397b-819f-e053-2a91aa0a208e 2 1048336 hyoscyamine sulfate 0.12 MG / methenamine 81 MG / methylene blue 10.8 MG / phenyl salicylate 32.4 MG / sodium phosphate, monobasic 40.8 MG Oral Tablet SCD 6cbeb7be-397b-819f-e053-2a91aa0a208e 2
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 58657-458-90 58657045890 90 TABLET in 1 BOTTLE (58657-458-90) 90 tablet 2016-06-17 0000-00-00 No No Current