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 13 of 36 · 713 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Quality Choice Lubricant Eye Drops High PerformancePOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLChain Drug Marketing Assoc., Inc.0cd1b36a-a07a-a1db-e063-6294a90a59942025-12-30WarningsExact identifier
unii: 6DC9Q167V3
Quality Choice Lubricant Eye Drops Long LastingPOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLChain Drug Marketing Assoc., Inc.0cd91c45-88a2-f88c-e063-6294a90ad1272025-12-30WarningsExact identifier
unii: 6DC9Q167V3
Quality Choice Eye WashWATERChain Drug Marketing Assoc., Inc.1fb8a109-351b-7039-e063-6394a90a73112025-12-30WarningsExact identifier
unii: 059QF0KO0R
Rite Aid Eye WashPURIFIED WATERRite Aid28a18e04-d735-a511-e063-6394a90af6bb2025-12-30WarningsExact identifier
unii: 059QF0KO0R
Archies Dry Eye ReliefPOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLArchie's Remedies07da099b-6b7f-984d-e063-6294a90a12ac2025-12-30WarningsExact identifier
unii: 6DC9Q167V3
OCUFRESHWATEROptics Laboratory Inc.b8e477a9-66b9-496b-92fb-3d4bbd7b36b52025-12-29WarningsExact identifier
unii: 059QF0KO0R
Kollourion Eyesalve EyewashPURIFIED WATER 98.3%Miracle Eye Pharmaceuticalsb56d2ab9-169b-b490-e053-2a95a90a80b32025-12-28WarningsExact identifier
unii: 059QF0KO0R
HEMORRHOIDALMINERAL OIL, PETROLATUM, PHENYLEPHRINE HYDROCHLORIDESafeway3e6728b6-26e3-4287-8ba6-e27f305cd93b2025-12-20WarningsExact identifier
unii: T5L8T28FGP
Walgreens LubricantPOLYETHYLENE GLYCOL 400, AND PROPYLENE GLYCOLWalgreens21dfe061-4538-2061-e063-6394a90a6e732025-12-19WarningsExact identifier
unii: 6DC9Q167V3
Sterile WaterWATERProPharma Distribution386a0a2f-4ff7-f128-e063-6294a90a7d4d2025-12-18Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
HepatatoxTRITICUM AESTIVUM, CHELIDONIUM MAJUS, TARAXACUM OFFICINALE, GLUTATHIONE, HEPAR SUIS, THYROIDINUM (SUIS), LYCOPODIUM CLAVATUM, NUX VOMICA, PHOSPHORICUM ACIDUM, ADRENOCORTICOTROPHIN, SALICYLICUM ACIDUM, CORTISONE ACETICUM, EUGENOL, STEARYL ALCOHOL, XYLITOL, FOLLICULINUM, BENZOICUM ACIDUM, CHLORINUM POTASSIUM SORBATE, SORBITOL, RESORCINUM, BENZYL ALCOHOL, LACTICUM ACIDUM, ISOPROPYL PALMITATE, BORICUM ACIDUM, ACETICUM ACIDUM, PHENYL BUTAZONE, PETROLEUM JELLY, PLUMBUM METALLICUMBioActive Nutritional, Inca113a9f1-4792-41a5-8d1b-a6756f356e152025-12-18WarningsExact identifier
unii: 8SKN0B0MIM
unii: 2KR89I4H1Y
foster and thrive miconazole 3MICONAZOLE NITRATEStrategic Sourcing Services LLC4c536e07-5e88-4bdd-a5b2-10226d5486ed2025-12-16WarningsExact identifier
application number: ANDA076357
ndc (package): 70677-1223-1
ndc (package): 0113-7198-00
ndc (package): 0113-8123-00
ndc (product): 70677-1223
rxcui: 998540
rxcui: 992816
rxcui: 998544
spl id: 890c9a2c-ce15-4400-9ecf-b205fc491d0b
spl set id: 4c536e07-5e88-4bdd-a5b2-10226d5486ed
Miconazole NitrateATHLETES FOOT POWDER SPRAY TALC FREETopco Associates LLC97334166-1dff-4ed2-ad31-f524b22097f92025-12-12WarningsExact identifier
unii: VW4H1CYW1K
Miconazole NitrateMICONAZOLE NITRATE ANTIFUNGAL POWDER SPRAYBetter Living Brandsccfef81b-f271-4551-e053-2a95a90a8ac42025-12-09WarningsExact identifier
unii: VW4H1CYW1K
Firstep FirstflushEYEWASHEncon Safety Products, Inc.a44beb26-79ae-98bd-e053-2995a90a9b742025-12-09WarningsExact identifier
unii: 059QF0KO0R
Miconazole NitrateANTI-FUNGAL MICONAZOLE ATHLETES FOOT SPRAY TALC FREEFoodhold USAa64c9371-0ac7-4c47-bc12-7bc77162b2442025-12-09WarningsExact identifier
unii: VW4H1CYW1K
Miconazole NitrateATHLETES FOOT POWDER SPRAY TALC FREEHarris Teeter, LLC02eb9c78-5a89-4958-b5a4-68f39e584cf22025-12-09WarningsExact identifier
unii: VW4H1CYW1K
Lotrimin AF Jock ItchMICONAZOLE NITRATEBayer Healthcare LLC.0c53cf0f-767e-a422-e063-6394a90ab7642025-12-04WarningsExact identifier
unii: VW4H1CYW1K
Lotrimin AF DeodorantMICONAZOLE NITRATEBayer HealthCare LLC.0bee54eb-df2f-15fe-e063-6294a90a2fd22025-12-04WarningsExact identifier
unii: VW4H1CYW1K
Lotrimin AFMICONAZOLE NITRATEBayer Healthcare LLC.163996c6-af54-21ac-e063-6394a90ac05c2025-12-04WarningsExact identifier
unii: VW4H1CYW1K

Reported adverse events (FAERS/openFDA)#

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