Home NDC 12539-144-01 Uretron D/S
Product NDC 12539-144
Requested package NDC 12539-144-01
11-digit product format 125390144
Labeler code 12539
Product ID 12539-144_463c4009-d0c3-e6a2-e063-6394a90ac76a
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Methenamine, Sodium Phosphate Monobasic, Phenyl Salicylate, Methylene Blue, and Hyoscyamine Sulfate
Dosage form TABLET
Route ORAL
Labeler DORAL PHARMAMEDICS INC dba A.G. Marin Pharmaceuticals
Marketing category UNAPPROVED DRUG OTHER
Marketing start 2022-10-07
Substance HYOSCYAMINE SULFATE; METHENAMINE; METHYLENE BLUE; PHENYL SALICYLATE; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE
Active strength .12; 81.6; 10.8; 36.2; 40.8 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 2026-12-31
Current FDA listing Yes 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 · 1 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 12539-144 12539-144-01 I Inactivated by FDA excluded / ndc_excluded.zip 1332a3947898…d4bfe170f9cd…
Additional Listing Data#
Finished product Yes
Brand name base Uretron D/S
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE .12 mg/1 PHENYL SALICYLATE 81.6 mg/1 HYOSCYAMINE SULFATE 10.8 mg/1 METHYLENE BLUE 36.2 mg/1 METHENAMINE 40.8 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 5 matching rows.
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1047786 Internal RxNorm lookup 1087457 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 12539-144-01 Uretron D/S 100 in 1 BOTTLE TABLET 100 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 12539-144 URETRON D/S (METHENAMINE, SODIUM PHOSPHATE MONOBASIC, PHENYL SALICYLATE, METHYLENE BLUE, AND HYOSCYAMINE SULFATE) TABLET [DORAL PHARMAMEDICS INC DBA A.G. MARIN PHARMACEUTICALS] 3 Current NDC, Legacy NDC, 1 package rows 20250303_ea74f1aa-2b4d-4ccf-e053-2995a90abab5.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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Uretron D/S METHENAMINE, SODIUM PHOSPHATE MONOBASIC, PHENYL SALICYLATE, METHYLENE BLUE, AND HYOSCYAMINE SULFATE DORAL PHARMAMEDICS INC dba A.G. Marin Pharmaceuticals ea74f1aa-2b4d-4ccf-e053-2995a90abab5 2025-12-18 Warnings, Adverse reactions Exact identifier ndc (package): 12539-144-01 ndc (product): 12539-144 ndc11 (package): 12539014401
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 12539-144-01 12539014401 100 TABLET in 1 BOTTLE (12539-144-01) 100 tablet 2022-10-07 0000-00-00 No No Current