Home NDC 28595-299-60 MB CAPS
Product NDC 28595-299
Requested package NDC 28595-299-60
11-digit product format 285950299
Labeler code 28595
Product ID 28595-299_2efeb5ff-bd09-a444-e063-6294a90a8581
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name methenamine, sodium phosphate, monobasic, monohydrate, phenyl salicylate, methylene blue, and hyoscyamine sulfate
Dosage form CAPSULE
Route ORAL
Labeler Allegis Pharmaceuticals, LLC
Marketing category UNAPPROVED DRUG OTHER
Marketing start 2025-02-25
Substance HYOSCYAMINE SULFATE; METHENAMINE; METHYLENE BLUE; PHENYL SALICYLATE; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE
Active strength .12; 120; 10.8; 36.2; 40.8 mg/1; mg/1; mg/1; mg/1; mg/1
Pharmacologic classes Oxidation-Reduction Activity [MoA], Oxidation-Reduction Agent [EPC]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Additional Listing Data#
Finished product Yes
Brand name base MB CAPS
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength METHENAMINE .12 mg/1 SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE 120 mg/1 PHENYL SALICYLATE 10.8 mg/1 METHYLENE BLUE 36.2 mg/1 HYOSCYAMINE SULFATE 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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2637557 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 28595-299-60 MB CAPS 60 in 1 BOTTLE CAPSULE 60 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 28595-299 MB CAPS (METHENAMINE, SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE, PHENYL SALICYLATE, METHYLENE BLUE, AND HYOSCYAMINE SULFATE) CAPSULE [ALLEGIS PHARMACEUTICALS, LLC] 1 Current NDC, 1 package rows 20250228_2efeb281-b84b-4750-e063-6394a90a27ee.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 MB CAPS METHENAMINE, SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE, PHENYL SALICYLATE, METHYLENE BLUE, AND HYOSCYAMINE SULFATE Allegis Pharmaceuticals, LLC 2efeb281-b84b-4750-e063-6394a90a27ee 2025-02-25 Warnings, Adverse reactions Exact identifier ndc (package): 28595-299-60 ndc (product): 28595-299 ndc11 (package): 28595029960
DailyMed RxNorm Mappings# RxCUI, RxNorm string, TTY table RxCUI RxNorm string TTY DailyMed SPL version 2637557 hyoscyamine sulfate 0.12 MG / methenamine 120 MG / methylene blue 10.8 MG / phenyl salicylate 36.2 MG / sodium phosphate, monobasic 40.8 MG Oral Capsule PSN 2efeb281-b84b-4750-e063-6394a90a27ee 1 2637557 hyoscyamine sulfate 0.12 MG / methenamine 120 MG / methylene blue 10.8 MG / phenyl salicylate 36.2 MG / sodium phosphate, monobasic 40.8 MG Oral Capsule SCD 2efeb281-b84b-4750-e063-6394a90a27ee 1
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 28595-299-60 28595029960 60 CAPSULE in 1 BOTTLE (28595-299-60) 60 capsule 2025-02-25 No No Current