FDA.reportPublic FDA data

Me NaPhos MB Hyo 1

Product NDC
58657-454
11-digit product format
586570454
Labeler code
58657
Product ID
58657-454_41b576a1-2a59-9f3c-e063-6394a90aec7d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Urinary Antiseptic Antispasmodic
Dosage form
TABLET
Route
ORAL
Labeler
Method Pharmaceuticals
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2015-12-01
Substance
HYOSCYAMINE SULFATE ANHYDROUS; METHENAMINE; METHYLENE BLUE ANHYDROUS; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE
Active strength
.12; 81.6; 10.8; 40.8 mg/1; mg/1; mg/1; mg/1
Pharmacologic classes
Oxidation-Reduction Activity [MoA], Oxidation-Reduction Agent [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Me NaPhos MB Hyo 1
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
METHENAMINE.12 mg/1
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE81.6 mg/1
METHYLENE BLUE ANHYDROUS10.8 mg/1
HYOSCYAMINE SULFATE ANHYDROUS40.8 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
J50OIX95QVInternal UNII lookup
593YOG76RNInternal UNII lookup
8NAP7826UBInternal UNII lookup
OB570Z127KInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1050325Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
2ae628e7-3b33-6a9a-e054-00144ff8d46cAvailable 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
efd58dcf-540a-4531-8766-e713129ca6f2Product name120250307
4b7700e3-6e0e-45e5-9d22-6f754d61386eProduct name220250304
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58657-454-01Me NaPhos MB Hyo 1100 in 1 BOTTLETABLET1008

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
58657-454-01EA - Each58657-4547dd0001b-b6ff-4b89-bc43-ecccda4e624712016-03-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58657-454ME NAPHOS MB HYO 1 (URINARY ANTISEPTIC ANTISPASMODIC) TABLET [METHOD PHARMACEUTICALS]7Current NDC, Legacy NDC, 1 package rows20241126_2ae628e7-3b33-6a9a-e054-00144ff8d46c.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
Me NaPhos MB Hyo 1URINARY ANTISEPTIC ANTISPASMODICMethod Pharmaceuticals2ae628e7-3b33-6a9a-e054-00144ff8d46c2025-10-21Warnings, Adverse reactionsExact identifier
ndc (product): 58657-454

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1050325methenamine 81.6 MG / sodium phosphate, monobasic 40.8 MG / methylene blue 10.8 MG / hyoscyamine sulfate 0.12 MG Oral TabletPSN2ae628e7-3b33-6a9a-e054-00144ff8d46c8
1050325hyoscyamine sulfate 0.12 MG / methenamine 81.6 MG / methylene blue 10.8 MG / sodium phosphate, monobasic 40.8 MG Oral TabletSCD2ae628e7-3b33-6a9a-e054-00144ff8d46c8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
58657-454-0158657045401100 TABLET in 1 BOTTLE (58657-454-01) 100 tablet2015-12-010000-00-00NoNoCurrent