Home NDC 0037-6321 URELLE
Product NDC 0037-6321
11-digit product format 000376321
Labeler code 0037
Product ID 0037-6321_a8f8f4f1-ad2a-40af-9089-764a459fb8fd
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name hyoscyamine sulfate, methenamine, methylene blue, phenyl salicylate, and sodium phosphate, monobasic, monohydrate
Dosage form TABLET
Route ORAL
Labeler Viatris Specialty LLC
Marketing category UNAPPROVED DRUG OTHER
Marketing start 2015-01-12
Substance HYOSCYAMINE SULFATE; METHENAMINE; METHYLENE BLUE; PHENYL SALICYLATE; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE
Active strength .12; 81; 10.8; 32.4; 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 URELLE
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength HYOSCYAMINE SULFATE .12 mg/1 METHENAMINE 81 mg/1 METHYLENE BLUE 10.8 mg/1 PHENYL SALICYLATE 32.4 mg/1 SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE 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 1048336 Internal RxNorm lookup 1048340 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 0037-6321-90 URELLE 90 in 1 BOTTLE TABLET 90 4
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded HYOSCYAMINE SULFATE ACTIVE INGREDIENT F2R8V82B84 URELLE (HYOSCYAMINE SULFATE, METHENAMINE, METHYLENE BLUE, PHENYL SALICYLATE, AND SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE) TABLET [MEDA PHARMACEUTICALS INC.] 1 METHENAMINE ACTIVE INGREDIENT J50OIX95QV URELLE (HYOSCYAMINE SULFATE, METHENAMINE, METHYLENE BLUE, PHENYL SALICYLATE, AND SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE) TABLET [MEDA PHARMACEUTICALS INC.] 1 METHYLENE BLUE ACTIVE INGREDIENT T42P99266K URELLE (HYOSCYAMINE SULFATE, METHENAMINE, METHYLENE BLUE, PHENYL SALICYLATE, AND SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE) TABLET [MEDA PHARMACEUTICALS INC.] 1 PHENYL SALICYLATE ACTIVE INGREDIENT 28A37T47QO URELLE (HYOSCYAMINE SULFATE, METHENAMINE, METHYLENE BLUE, PHENYL SALICYLATE, AND SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE) TABLET [MEDA PHARMACEUTICALS INC.] 1 SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE ACTIVE INGREDIENT 593YOG76RN URELLE (HYOSCYAMINE SULFATE, METHENAMINE, METHYLENE BLUE, PHENYL SALICYLATE, AND SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE) TABLET [MEDA PHARMACEUTICALS INC.] 1 HYOSCYAMINE ACTIVE MOIETY PX44XO846X URELLE (HYOSCYAMINE SULFATE, METHENAMINE, METHYLENE BLUE, PHENYL SALICYLATE, AND SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE) TABLET [MEDA PHARMACEUTICALS INC.] 1 METHENAMINE ACTIVE MOIETY J50OIX95QV URELLE (HYOSCYAMINE SULFATE, METHENAMINE, METHYLENE BLUE, PHENYL SALICYLATE, AND SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE) TABLET [MEDA PHARMACEUTICALS INC.] 1 METHYLENE BLUE CATION ACTIVE MOIETY ZMZ79891ZH URELLE (HYOSCYAMINE SULFATE, METHENAMINE, METHYLENE BLUE, PHENYL SALICYLATE, AND SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE) TABLET [MEDA PHARMACEUTICALS INC.] 1 PHENYL SALICYLATE ACTIVE MOIETY 28A37T47QO URELLE (HYOSCYAMINE SULFATE, METHENAMINE, METHYLENE BLUE, PHENYL SALICYLATE, AND SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE) TABLET [MEDA PHARMACEUTICALS INC.] 1 PHOSPHATE ION ACTIVE MOIETY NK08V8K8HR URELLE (HYOSCYAMINE SULFATE, METHENAMINE, METHYLENE BLUE, PHENYL SALICYLATE, AND SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE) TABLET [MEDA PHARMACEUTICALS INC.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0037-6321 URELLE (HYOSCYAMINE SULFATE, METHENAMINE, METHYLENE BLUE, PHENYL SALICYLATE, AND SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE) TABLET [MEDA PHARMACEUTICALS] 3 Current NDC, Legacy NDC, 1 package rows 20181205_1d80a11c-6f86-403b-85d4-32ec1924dbe9.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 URELLE HYOSCYAMINE SULFATE, METHENAMINE, METHYLENE BLUE, PHENYL SALICYLATE, AND SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE Viatris Specialty LLC 1d80a11c-6f86-403b-85d4-32ec1924dbe9 2015-01-13 Warnings, Adverse reactions Exact identifier ndc (product): 0037-6321
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 0037-6321-90 00037632190 90 TABLET in 1 BOTTLE (0037-6321-90) 90 tablet 2015-01-12 0000-00-00 No No Current