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

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Methenamine Mandelate	METHENAMINE MANDELATE	Oncora Pharma, LLC	d4b79e41-eb29-4d30-aa8f-e964c16bf002	2026-04-17	Adverse reactions	Exact identifier ndc (product): 85477-115

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
METHENAMINE MANDELATE	500 mg/5mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
695N30CINR	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
d4b79e41-eb29-4d30-aa8f-e964c16bf002	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
260b0da6-d3d7-262f-a60f-d4b36d5f1b4d	Product name	6	20251210

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
85477-115-16	Methenamine Mandelate	473 mL in 1 BOTTLE	SOLUTION	473		1

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
695N30CINR	METHENAMINE MANDELATE	587-23-5	METHENAMINE MANDELATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2741045	methenamine mandelate 500 MG in 5 mL Oral Solution	PSN	d4b79e41-eb29-4d30-aa8f-e964c16bf002	1
2741045	methenamine mandelate 100 MG/ML Oral Solution	SCD	d4b79e41-eb29-4d30-aa8f-e964c16bf002	1
2741045	methenamine mandelate 500 MG per 5 ML Oral Solution	SY	d4b79e41-eb29-4d30-aa8f-e964c16bf002	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
85477-115-16	85477011516	473 mL in 1 BOTTLE (85477-115-16)	473 ml	2026-04-20	No	No	Current