FDA.reportPublic FDA data

Methenamine Mandelate

Product NDC
85477-115
11-digit product format
854770115
Labeler code
85477
Product ID
85477-115_4fa726e6-84de-0f28-e063-6294a90aafe9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Methenamine Mandelate
Dosage form
SOLUTION
Route
ORAL
Labeler
Oncora Pharma, LLC
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2026-04-20
Substance
METHENAMINE MANDELATE
Active strength
500 mg/5mL
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Methenamine Mandelate
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
METHENAMINE MANDELATE500 mg/5mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
695N30CINRInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2741045Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
d4b79e41-eb29-4d30-aa8f-e964c16bf002Available 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
85477-115-16Methenamine Mandelate473 mL in 1 BOTTLESOLUTION4731

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
Methenamine MandelateMETHENAMINE MANDELATEOncora Pharma, LLCd4b79e41-eb29-4d30-aa8f-e964c16bf0022026-04-17Adverse reactionsExact identifier
ndc (product): 85477-115

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2741045methenamine mandelate 500 MG in 5 mL Oral SolutionPSNd4b79e41-eb29-4d30-aa8f-e964c16bf0021
2741045methenamine mandelate 100 MG/ML Oral SolutionSCDd4b79e41-eb29-4d30-aa8f-e964c16bf0021
2741045methenamine mandelate 500 MG per 5 ML Oral SolutionSYd4b79e41-eb29-4d30-aa8f-e964c16bf0021

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85477-115-1685477011516473 mL in 1 BOTTLE (85477-115-16) 473 ml2026-04-20NoNoCurrent