FDA.reportPublic FDA data

Methenamine Mandelate

Product NDC
69367-436
11-digit product format
693670436
Labeler code
69367
Product ID
69367-436_6e6f983d-9926-4c26-afc1-0946184911d1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Methenamine Mandelate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Westminster Pharmaceuticals, LLC
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2026-03-19
Substance
METHENAMINE MANDELATE
Active strength
500 mg/1
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
Methenamine MandelateMETHENAMINE MANDELATEWestminster Pharmaceuticals, LLC1d76d132-6fd8-4139-989b-0bc38257ea3b2026-03-26Warnings, Adverse reactionsExact identifier
ndc (product): 69367-436

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/1

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 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
992153Internal RxNorm lookup
992184Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
1d76d132-6fd8-4139-989b-0bc38257ea3bAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
260b0da6-d3d7-262f-a60f-d4b36d5f1b4dProduct name620251210
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69367-436-01Methenamine Mandelate100 in 1 BOTTLETABLET, FILM COATED1001
69367-436-60Methenamine Mandelate60 in 1 BOTTLETABLET, FILM COATED601

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69367-436-01EA - Each69367-43608f4686d-9df6-48be-9463-5db703158c2d12026-05-22
69367-436-60EA - Each69367-436bfdbb239-46dc-42ee-a160-8a3d5cf412b112026-05-22

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
992184methenamine mandelate 500 MG Oral TabletPSN23a57107-3709-4578-86e0-e5ca99435e7a100
992184methenamine mandelate 500 MG Oral TabletSCD23a57107-3709-4578-86e0-e5ca99435e7a100
992153methenamine mandelate 1000 MG Oral TabletPSN1d76d132-6fd8-4139-989b-0bc38257ea3b1
992184methenamine mandelate 500 MG Oral TabletPSN1d76d132-6fd8-4139-989b-0bc38257ea3b1
992153methenamine mandelate 1000 MG Oral TabletSCD1d76d132-6fd8-4139-989b-0bc38257ea3b1
992184methenamine mandelate 500 MG Oral TabletSCD1d76d132-6fd8-4139-989b-0bc38257ea3b1
992153methenamine mandelate 1 GM Oral TabletSY1d76d132-6fd8-4139-989b-0bc38257ea3b1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
69367-436-0169367043601100 TABLET, FILM COATED in 1 BOTTLE (69367-436-01) 2026-03-19NoNoCurrent
69367-436-606936704366060 TABLET, FILM COATED in 1 BOTTLE (69367-436-60) 2026-03-19NoNoCurrent