FDA.reportPublic FDA data

URO-PAIN Dual Action

Product NDC
57237-332
11-digit product format
572370332
Labeler code
57237
Product ID
57237-332_7de0855a-1d70-49b9-85a2-d25806e13f20
Type
HUMAN OTC DRUG
Nonproprietary name
Methenamine, Sodium salicylate
Dosage form
TABLET
Route
ORAL
Labeler
Rising Pharma Holdings, Inc.
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2023-12-06
Substance
METHENAMINE; SODIUM SALICYLATE
Active strength
162; 162.5 mg/1; mg/1
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
URO-PAIN Dual Action
Brand name suffix
Antibacterial Protection
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
METHENAMINE162 mg/1
SODIUM SALICYLATE162.5 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
J50OIX95QVInternal UNII lookup
WIQ1H85SYPInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1489932Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
f8ff15be-e537-4acc-a6e6-5934ff8b48aeAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
260b0da6-d3d7-262f-a60f-d4b36d5f1b4dProduct name620251210

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57237-332-42URO-PAIN Dual ActionAntibacterial Protection24 in 1 BLISTER PACKTABLET241
57237-332-42URO-PAIN Dual ActionAntibacterial Protection1 in 1 BOXTABLET11
57237-332-81URO-PAIN Dual ActionAntibacterial Protection1 in 1 BOXTABLET11
57237-332-81URO-PAIN Dual ActionAntibacterial Protection18 in 1 BLISTER PACKTABLET181

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
57237-332-42EA - Each57237-332a4a53466-c0f9-48e5-9c45-b64f6a5f5f4712024-03-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57237-332URO-PAIN DUAL ACTION ANTIBACTERIAL PROTECTION (METHENAMINE, SODIUM SALICYLATE) TABLET [RISING PHARMA HOLDINGS, INC.]1Current NDC, 4 package rows20240113_f8ff15be-e537-4acc-a6e6-5934ff8b48ae.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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
URO-PAIN Dual Action Antibacterial ProtectionMETHENAMINE, SODIUM SALICYLATERising Pharma Holdings, Inc.f8ff15be-e537-4acc-a6e6-5934ff8b48ae2023-12-28WarningsExact identifier
ndc (product): 57237-332

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1489932methenamine 162 MG / sodium salicylate 162.5 MG Oral TabletPSNf8ff15be-e537-4acc-a6e6-5934ff8b48ae1
1489932methenamine 162 MG / sodium salicylate 162.5 MG Oral TabletSCDf8ff15be-e537-4acc-a6e6-5934ff8b48ae1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
57237-332-42572370332421 BLISTER PACK in 1 BOX (57237-332-42) / 24 TABLET in 1 BLISTER PACK1 blister pack2023-12-06NoNoCurrent
57237-332-81572370332811 BLISTER PACK in 1 BOX (57237-332-81) / 18 TABLET in 1 BLISTER PACK1 blister pack2023-12-06NoNoCurrent