FDA.reportPublic FDA data

NDC 0113-7198 - Rugby Miconazole 3

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
0113-7198
Package NDCs from labels
0113-7198-00
Manufacturer
Rugby Laboratories
Effective date
2026-02-25
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Rugby Miconazole 3 - Rugby LaboratoriesRugby Laboratories2026-02-25HUMAN OTC DRUG LABEL
foster and thrive miconazole 3 - Strategic Sourcing Services LLCStrategic Sourcing Services LLC2025-12-16HUMAN OTC DRUG LABEL
Leader Miconazole 3 - Cardinal Health 110, LLC. dba LeaderCardinal Health 110, LLC. dba Leader2025-09-29HUMAN OTC DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0113-7198-00foster and thrive miconazole 35 g in 1 APPLICATORCREAM15 g4 g in 100g3
0113-7198-00foster and thrive miconazole 31 in 1 POUCHCREAM4 g in 100g3
0113-7198-00Rugby Miconazole 31 in 1 POUCHCREAM4 g in 100g3
0113-7198-00Rugby Miconazole 35 g in 1 APPLICATORCREAM15 g4 g in 100g3
0113-7198-00Leader Miconazole 35 g in 1 APPLICATORCREAM15 g4 g in 100g2
0113-7198-00Leader Miconazole 31 in 1 POUCHCREAM4 g in 100g2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0113-7198FOSTER AND THRIVE MICONAZOLE 3 (MICONAZOLE NITRATE) KIT [STRATEGIC SOURCING SERVICES LLC]2Unmatched20240622_4c536e07-5e88-4bdd-a5b2-10226d5486ed.zip
0113-7198LEADER MICONAZOLE 3 (MICONAZOLE NITRATE) KIT [CARDINAL HEALTH 110, LLC. DBA LEADER]1Unmatched20240711_7f6df893-f404-4b2d-ab2b-696c8a2d36fa.zip
0113-7198RUGBY MICONAZOLE 3 (MICONAZOLE NITRATE) KIT [RUGBY LABORATORIES]1Unmatched20240711_2d7035fa-9695-4d66-89f5-bd26420450ef.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 9 of 36 · 713 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Rugby Miconazole 3MICONAZOLE NITRATERugby Laboratories2d7035fa-9695-4d66-89f5-bd26420450ef2026-02-25WarningsExact identifier
application number: ANDA076357
ndc (package): 0113-7198-00
ndc (package): 0536-1425-41
ndc (package): 0113-8123-00
ndc (product): 0536-1425
rxcui: 998540
rxcui: 992816
rxcui: 998544
spl id: 1ce3070d-0513-43e8-99f9-c582bb707f51
spl set id: 2d7035fa-9695-4d66-89f5-bd26420450ef
Mineral OilMINERAL OILBetter Living Brands, LLC7f2f1b30-497a-4c53-accc-8455169b17b32026-02-24Warnings, Adverse reactionsExact identifier
unii: T5L8T28FGP
miconazole 3MICONAZOLE NITRATEKroger Company063153cc-00fd-4390-bc68-90b21203678a2026-02-23WarningsExact identifier
ndc (package): 0113-8123-00
rxcui: 998540
Hermon Jock Itch spray.MICONAZOLE NITRATE 2%Beautivity LLC4b633528-667a-f34e-e063-6294a90a2b3d2026-02-21WarningsExact identifier
unii: VW4H1CYW1K
Mineral OilMINERAL OILPerrigo Direct, Incf1656280-fad9-4922-9d5c-be774a8b14222026-02-19Warnings, Adverse reactionsExact identifier
unii: T5L8T28FGP
Mineral OilMINERAL OILMeijer, Inc.652d1da9-a71f-4113-9ef3-da09167246252026-02-19Warnings, Adverse reactionsExact identifier
unii: T5L8T28FGP
Miconazole NitrateMICONAZOLE NITRATEA-S Medication Solutionsa32fc37b-bcad-4f56-8dc6-cf36a67161962026-02-19WarningsExact identifier
rxcui: 998540
unii: VW4H1CYW1K
Mineral OilMINERAL OILTarget Corporation526508f0-e908-4e3d-88f5-404a95f6de762026-02-18Warnings, Adverse reactionsExact identifier
unii: T5L8T28FGP
Mineral OilMINERAL OILUnited Natural Foods, Inc. dba UNFIcb7bc571-295f-47c2-ae93-18cba194752c2026-02-17Warnings, Adverse reactionsExact identifier
unii: T5L8T28FGP
Mineral OilMINERAL OILStrategic Sourcing Services LLCe4965086-dcc0-4b34-bb30-81facf7139f32026-02-17Warnings, Adverse reactionsExact identifier
unii: T5L8T28FGP
Mineral OilMINERAL OILTopco Associates LLCe9b1fd61-c229-4529-82c2-d6ac5b0760822026-02-13WarningsExact identifier
unii: T5L8T28FGP
Happy Nuts Jock Itch PowderMICONAZOLE NITRATESuit Up Brands LLC42e2d9df-6537-b3a1-e063-6394a90a47b72026-02-13WarningsExact identifier
unii: VW4H1CYW1K
Mineral OilMINERAL OILWalgreen Co.822fd02a-92b0-4010-8bfb-737dba331d542026-02-12Warnings, Adverse reactionsExact identifier
unii: T5L8T28FGP
Kerova Miconazole NitrateMICONAZOLE NITRATEGuangzhou Bixiaoyu Trading Co., Ltd.3b8b5547-f8d1-9e48-e063-6294a90af4292026-02-12WarningsExact identifier
unii: VW4H1CYW1K
Miconazole NitrateATHLETES FOOT SPRAYCVS Pharmacy1f5e3bfb-b6b9-4b22-9c34-71112bcf0c3c2026-02-10WarningsExact identifier
unii: VW4H1CYW1K
Droptics Performance Eye DropsNAPHAZOLINE HYDROCHLORIDE, PROPYLENE GLYCOLDroptics LLC20fd6822-a7fd-4593-92bb-0a07260893e22026-02-09WarningsExact identifier
unii: 6DC9Q167V3
Fungus Master Antifungal TreatmentMICONAZOLE NITRATEEbanel Laboratories, Incf7b011b2-11e5-46f1-afed-89f438985e002026-02-09WarningsExact identifier
unii: VW4H1CYW1K
Mineral OilMINERAL OILRetail Business Services, LLCb0abcdf9-c226-424f-8970-c2135708c6c82026-02-06Warnings, Adverse reactionsExact identifier
unii: T5L8T28FGP
Signature Care HemorrhoidalMINERAL OIL, PETROLATUM, AND PHENYLEPHRINE HCIBetter Living Brands, LLC3c8b43f3-6e1e-499e-ba71-ffdf836f67432026-02-05WarningsExact identifier
unii: T5L8T28FGP
0.25 % PHENYLEPHRINE HCl HEMORRHOIDALMINERAL OIL, PETROLATUM, PHENYLEPHRINE HYDROCHLORIDENantong Health & Beyond Hygienic Products Inc.1cada0ae-3f0f-441c-a633-faa0a3009d2b2026-02-05WarningsExact identifier
unii: T5L8T28FGP

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.