URIBEL TABS

Product NDC
0178-0745
11-digit product format
001780745
Labeler code
0178
Product ID
0178-0745_47e8083a-60e6-b517-e063-6294a90ac104
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Methenamine, Benzoic Acid, Phenyl Salicylate, Methylene Blue, and Hyoscyamine Sulfate
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Mission Pharmacal Company
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2023-11-07
Substance
BENZOIC ACID; HYOSCYAMINE SULFATE; METHENAMINE; METHYLENE BLUE; PHENYL SALICYLATE
Active strength
9; .12; 81.6; 10.8; 36.2 mg/1; mg/1; mg/1; mg/1; mg/1
Pharmacologic classes
Ammonium Ion Binding Activity [MoA], Nitrogen Binding Agent [EPC], Oxidation-Reduction Activity [MoA], Oxidation-Reduction Agent [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
URIBEL TABSMETHENAMINE, BENZOIC ACID, PHENYL SALICYLATE, METHYLENE BLUE, AND HYOSCYAMINE SULFATEMission Pharmacal Company09821e01-1135-e75c-e063-6294a90a34512026-01-08WarningsExact identifier
ndc (product): 0178-0745

Additional Listing Data#

Finished product
Yes
Brand name base
URIBEL TABS
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HYOSCYAMINE SULFATE9 mg/1
PHENYL SALICYLATE.12 mg/1
METHENAMINE81.6 mg/1
METHYLENE BLUE10.8 mg/1
BENZOIC ACID36.2 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 5 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
F2R8V82B84Internal UNII lookup
28A37T47QOInternal UNII lookup
J50OIX95QVInternal UNII lookup
T42P99266KInternal UNII lookup
8SKN0B0MIMInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1037234Internal RxNorm lookup
2670308Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
09821e01-1135-e75c-e063-6294a90a3451Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
260b0da6-d3d7-262f-a60f-d4b36d5f1b4dProduct name620251210
c39b72c3-7732-4ed2-a995-e6aa3a665a54Product name320250819
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0178-0745-01URIBEL TABS100 in 1 BOTTLETABLET, COATED1004

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0178-0745-01EA - Each0178-0745926c7a12-77ff-49f7-b40b-76f789bcb74f12023-12-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0178-0745URIBEL TABS (METHENAMINE, BENZOIC ACID, PHENYL SALICYLATE, METHYLENE BLUE, AND HYOSCYAMINE SULFATE) TABLET, COATED [MISSION PHARMACAL COMPANY]3Current NDC, 1 package rows20240123_09821e01-1135-e75c-e063-6294a90a3451.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1037234methenamine 81.6 MG / phenyl salicylate 36.2 MG / methylene blue 10.8 MG / benzoic acid 9 MG / hyoscyamine sulfate 0.12 MG Oral TabletPSN09821e01-1135-e75c-e063-6294a90a34514
2670308Uribel Tabs 81.6 MG / 9 MG / 36.2 MG / 10.8 MG / 0.12 MG Oral TabletPSN09821e01-1135-e75c-e063-6294a90a34514
2670308benzoic acid 9 MG / hyoscyamine sulfate 0.12 MG / methenamine 81.6 MG / methylene blue 10.8 MG / phenyl salicylate 36.2 MG Oral Tablet [Uribel Tabs]SBD09821e01-1135-e75c-e063-6294a90a34514
1037234benzoic acid 9 MG / hyoscyamine sulfate 0.12 MG / methenamine 81.6 MG / methylene blue 10.8 MG / phenyl salicylate 36.2 MG Oral TabletSCD09821e01-1135-e75c-e063-6294a90a34514
2670308Uribel Tabs (benzoic acid 9 MG / hyoscyamine sulfate 0.12 MG / methenamine 81.6 MG / methylene blue 10.8 MG / phenyl salicylate 36.2 MG) Oral TabletSY09821e01-1135-e75c-e063-6294a90a34514

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
0178-0745-0100178074501100 TABLET, COATED in 1 BOTTLE (0178-0745-01) 2023-11-07NoNoCurrent