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 24 of 36 · 713 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ChemtoxTRITICUM AESTIVUM, BERBERIS VULGARIS, GLYCYRRHIZA GLABRA, LAPPA MAJOR, RHAMNUS FRANGULA, RHAMNUS PURSHIANA, STILLINGIA SYLVATICA, TRIFOLIUM PRATENSE, XANTHOXYLUM FRAXINEUM, PHYTOLACCA DECANDRA, GLANDULA SUPRARENALIS SUIS, HEPAR SUIS, LYMPH NODE (SUIS), THYROIDINUM (SUIS), BELLADONNA, LYCOPODIUM CLAVATUM, NITRICUM ACIDUM, NUX VOMICA, PHOSPHORICUM ACIDUM, PHOSPHORUS, SALICYLICUM ACIDUM, CORTISONE ACETICUM, EUGENOL, STEARYL ALCOHOL, XYLITOL, FOLLICULINUM, BENZOICUM ACIDUM, CHLORINUM, POTASSIUM SORBATE,BioActive Nutritional, Inc.a480e5f4-5f9e-4b23-b257-b0ac1ebfc1152025-01-07WarningsExact identifier
unii: 8SKN0B0MIM
unii: 2KR89I4H1Y
MICONAZOLE 3 COMBINATION PACK (miconazole nitrate) kitMICONAZOLE NITRATECosette Pharmaceuticals, Inc.eed88487-a7ba-4853-8519-13f92ed5539f2025-01-06WarningsExact identifier
rxcui: 998540
Arthritis EaseARNICA, BENZOICUM AC, BRYONIA, CALC PHOS, COLCHIUM, RHUS TOX, RUTASilver Star Brandsc68b587f-14eb-395a-e053-2a95a90ae8012025-01-01WarningsExact identifier
unii: 8SKN0B0MIM
NativeRemedies Gout-GoneANTIMON CRUD, BENZOICUM AC, LEDUM, NUX VOM, QUERCUS, RHODODENDRON, SILICEASilver Star Brandsf66b42f0-8f5f-1aca-e053-2a95a90ae3962025-01-01WarningsExact identifier
unii: 8SKN0B0MIM
VISTA MEIBO TEARS Propylene Glycol 0.6% w/v Advanced Dry Eye Relief Lubricating Drops 10 mlPROPYLENE GLYCOLRed Wedding LLCb2c2fd0f-b944-6b0b-e053-2995a90aa2162025-01-01WarningsExact identifier
unii: 6DC9Q167V3
Rite Aid Hydration Lubricant Eye DropsPOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLRite Aid Corporationecac1351-e944-21da-e053-2995a90a6d342024-12-31WarningsExact identifier
unii: 6DC9Q167V3
Lubricant Eye PMMINERAL OIL, WHITE PETROLATUMReliable 1 Laboratories LLCbaec8045-97fe-6f60-e053-2a95a90a050e2024-12-31WarningsExact identifier
unii: T5L8T28FGP
AD Medicated RashAD MEDICATED RASHWellSpring Pharmaceutical Corporationaac345bf-ea66-4f5b-a497-c24ea72f93ea2024-12-27WarningsExact identifier
unii: T5L8T28FGP
Vite20MICONAZOLE NITRATEBlaine Labs Inc.28a8d0dd-aab9-44ff-bab6-7ec4b5036a712024-12-24WarningsExact identifier
unii: VW4H1CYW1K
Household AntigensACETONE, SODIUM TRIPOLYPHOSPHATE, PROPYLENE GLYCOL, BENZINUM, AMMONIUM MURIATICUM, SODIUM LAURYL SULFATE, TEREBINTHINA, BUTYL ACETATE, ETHYL ACETATE, TOLUENE, XYLENE, BISPHENOL A, PETROLEUM, FORMALINUM, GLYPHOSATE, METHYLPARABEN, NAPHTHALINUM, PROPYLPARABEN, ANACARDIUM ORIENTALE, GRAPHITES, NITRICUM ACIDUM, PULSATILLA (PRATENSIS), SULPHUR, PARAFFINUMEnergique, Inc.f3db63df-62a4-48d6-92e7-94e4a57015522024-12-20WarningsExact identifier
unii: 6DC9Q167V3
Miconazole NitrateANTIFUNGAL MICONAZOLE POWDER SPRAYPremier Brands of America Inc.dc7a23bb-b246-89b1-e053-2995a90a9f2d2024-12-20WarningsExact identifier
unii: VW4H1CYW1K
Warrior Antifungal FootMICONAZOLE NITRATE 2%Derma Care Research Labs, LLCcf2e9dc1-275b-4454-e053-2995a90af2952024-12-20WarningsExact identifier
unii: VW4H1CYW1K
HemorrhoidalOintmentMINERAL OIL, PETROLATUM, PHENYLEPHRINE HCIPharmacy Value Alliance, LLC3803a61b-308a-14a9-e054-00144ff88e882024-12-20WarningsExact identifier
unii: T5L8T28FGP
HemorrhoidalOintmentMINERAL OIL, PETROLATUM, PHENYLEPHRINE HCITrifecta Pharmaceuticals USA LLCc50cc6ad-e8a0-47c1-e053-2a95a90a4de62024-12-18WarningsExact identifier
unii: T5L8T28FGP
HemorrhoidalOintmentMINERAL OIL, PETROLATUM, PHENYLEPHRINE HCITrifecta Pharmaceuticals USA LLCfe18fa61-83f9-8bf9-e053-6294a90a75852024-12-18WarningsExact identifier
unii: T5L8T28FGP
HemorrhoidalOintmentMINERAL OIL, PETROLATUM, PHENYLEPHRINE HCITrifecta Pharmaceuticals USA LLCc59dcb2a-392b-670b-e053-2995a90a96822024-12-18WarningsExact identifier
unii: T5L8T28FGP
TheraCare HemorrhoidalMINERAL OIL, PETROLATUM, PHENYLEPHRINE HCLVeridian Healthcarefab95657-d257-e671-e053-6294a90a59e02024-12-18WarningsExact identifier
unii: T5L8T28FGP
Recticare AdvancedLIDOCAINE AND MINERAL OIL AND PHENYLEPHRINE HCL AND WHITE PETROLATUMFerndale Laboratories, Inc.209212a7-7b6e-4b26-9f31-0eeb76f026bf2024-12-17WarningsExact identifier
unii: T5L8T28FGP
HemorrhoidalMINERAL OIL, PETROLATUM, PHENYLEPHRINE HCIRugbya5b5e0a9-eee9-2a1e-e053-2a95a90a464e2024-12-17WarningsExact identifier
unii: T5L8T28FGP
MICONAZOLE Nitrate 2% Cream ANTIFUNGALMICONAZOLE NITRATERugbyf420de00-408f-9a2c-e053-2995a90adced2024-12-17WarningsExact identifier
unii: VW4H1CYW1K

Reported adverse events (FAERS/openFDA)#

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