FDA.reportPublic FDA data

NDC 0113-6650 - 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
0113-6650
Package NDCs from labels
0113-6650-00
Manufacturer
Kroger Company
Effective date
2026-02-23
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
miconazole 3 - Kroger CompanyKroger Company2026-02-23HUMAN OTC DRUG LABEL
Miconazole 3 - SafewaySafeway2025-11-01HUMAN OTC DRUG LABEL
Miconazole 3 - CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATEDCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED2025-10-23HUMAN OTC DRUG LABEL
Wal-Mart Miconazole 3 Drug FactsWALMART INC.2025-09-23HUMAN OTC DRUG LABEL
Foster and Thrive Miconazole 3 - Strategic Sourcing Services LLCStrategic Sourcing Services LLC2025-08-12HUMAN OTC DRUG LABEL
miconazole 3 - Rite Aid CorporationRite Aid Corporation2023-11-08HUMAN OTC DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0113-6650-00Equate Miconazole 31 in 1 BLISTER PACKSUPPOSITORY3200 mg3
0113-6650-00Equate Miconazole 33 in 1 KITSUPPOSITORY200 mg3
0113-6650-00Miconazole 33 in 1 KITSUPPOSITORY200 mg3
0113-6650-00Miconazole 31 in 1 BLISTER PACKSUPPOSITORY3200 mg3
0113-6650-00miconazole 31 in 1 BLISTER PACKSUPPOSITORY3200 mg2
0113-6650-00Miconazole 33 in 1 KITSUPPOSITORY200 mg2
0113-6650-00Miconazole 31 in 1 BLISTER PACKSUPPOSITORY3200 mg2
0113-6650-00Foster and Thrive Miconazole 31 in 1 BLISTER PACKSUPPOSITORY3200 mg2
0113-6650-00Foster and Thrive Miconazole 33 in 1 KITSUPPOSITORY200 mg2
0113-6650-00miconazole 33 in 1 KITSUPPOSITORY200 mg2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0113-6650EQUATE MICONAZOLE 3 (MICONAZOLE NITRATE) KIT [WALMART INC.]2Unmatched20231213_5ade4c65-5757-4f20-b5be-f95d86363d11.zip
0113-6650MICONAZOLE 3 (MICONAZOLE NITRATE) KIT [RITE AID CORPORATION]2Unmatched20231111_4abee369-e8c5-4971-9545-8c015ff6eaad.zip
0113-6650MICONAZOLE 3 (MICONAZOLE NITRATE) KIT [SAFEWAY]2Unmatched20250529_b32aec61-32c0-4c7f-b843-348243332583.zip
0113-6650FOSTER AND THRIVE MICONAZOLE 3 (MICONAZOLE NITRATE) KIT [STRATEGIC SOURCING SERVICES LLC]1Unmatched20231109_ba5d5b13-5604-4b8c-92b9-9f4174458029.zip
0113-6650MICONAZOLE 3 (MICONAZOLE NITRATE) KIT [CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED]1Unmatched20240606_689ad530-48f9-4044-baa3-4f8b0657aeef.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MICONAZOLE NITRATEACTIVE INGREDIENTVW4H1CYW1KMICONAZOLE 3 (MICONAZOLE NITRATE) KIT [KROGER COMPANY]1
MICONAZOLEACTIVE MOIETY7NNO0D7S5MMICONAZOLE 3 (MICONAZOLE NITRATE) KIT [KROGER COMPANY]1
BENZOIC ACIDINACTIVE INGREDIENT8SKN0B0MIMMICONAZOLE 3 (MICONAZOLE NITRATE) KIT [KROGER COMPANY]1
BUTYLATED HYDROXYANISOLEINACTIVE INGREDIENTREK4960K2UMICONAZOLE 3 (MICONAZOLE NITRATE) KIT [KROGER COMPANY]1
COTTONSEED OILINACTIVE INGREDIENTH3E878020NMICONAZOLE 3 (MICONAZOLE NITRATE) KIT [KROGER COMPANY]1
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE4MICONAZOLE 3 (MICONAZOLE NITRATE) KIT [KROGER COMPANY]1
MINERAL OILINACTIVE INGREDIENTT5L8T28FGPMICONAZOLE 3 (MICONAZOLE NITRATE) KIT [KROGER COMPANY]1
PEG-5 OLEATEINACTIVE INGREDIENT0240V77G50MICONAZOLE 3 (MICONAZOLE NITRATE) KIT [KROGER COMPANY]1
PEGOXOL 7 STEARATEINACTIVE INGREDIENT3EW5AXE5X5MICONAZOLE 3 (MICONAZOLE NITRATE) KIT [KROGER COMPANY]1
WATERINACTIVE INGREDIENT059QF0KO0RMICONAZOLE 3 (MICONAZOLE NITRATE) KIT [KROGER COMPANY]1

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 15 of 32 · 629 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Monistat 7 with Reusable ApplicatorMICONAZOLE NITRATEInsight Pharmaceuticals LLC2aad40f2-4eea-441d-8b34-5613f19554052025-10-27WarningsExact identifier
rxcui: 998540
unii: VW4H1CYW1K
Miconazole NitrateJOCK ITCH SPRAY TALC FREEAmerican Sales Company4354b71e-6268-440d-b916-0403c6fc3ddb2025-10-27WarningsExact identifier
unii: VW4H1CYW1K
Miconazole NitrateANTI-FUNGAL POWDER MICONAZOLE NITRATE TALC FREEHudson Health LLC36ec5f05-5d1c-25df-e063-6394a90a9dd92025-10-24WarningsExact identifier
unii: VW4H1CYW1K
Monistat 3 3 DayMICONAZOLE NITRATEInsight Pharmaceuticals LLCf38c7e1d-2439-4b3b-8be8-60b2d8e61ce52025-10-23WarningsExact identifier
unii: VW4H1CYW1K
Winco HemorrhoidalMINERAL OIL, PETROLATUM, AND PHENYLEPHRINE HYDROCHLORIDEWinco Foods, LLC04ca3ef1-fc6b-4683-b236-a75afc031fb52025-10-23WarningsExact identifier
unii: T5L8T28FGP
CareOne Miconazole 3MICONAZOLE NITRATEAmerican Sales Company84c43793-98e4-4e68-a3bc-3e72221355682025-10-23WarningsExact identifier
application number: ANDA075329
rxcui: 992765
rxcui: 992766
rxcui: 998540
Miconazole 3MICONAZOLE NITRATECVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED689ad530-48f9-4044-baa3-4f8b0657aeef2025-10-23WarningsExact identifier
application number: ANDA075329
ndc (package): 51316-689-00
ndc (package): 0113-6650-00
ndc (package): 0113-8123-00
ndc (product): 51316-689
rxcui: 992765
rxcui: 992766
rxcui: 998540
spl id: e55b2ee9-0e90-4788-88b1-ff25dc81b1ce
spl set id: 689ad530-48f9-4044-baa3-4f8b0657aeef
Family Care HemorrhoidalMINERAL OILUnited Exchange Corp04375257-f4f3-48c3-a338-de43298b95eb2025-10-22WarningsExact identifier
unii: T5L8T28FGP
Family Wellness HemorrhoidalMINERAL OIL, PETROLATUM, AND PHENYLEPHRINE HCLFamily Dollar Services, Incfe3293bc-80b5-b60a-e053-6394a90a4ede2025-10-22WarningsExact identifier
unii: T5L8T28FGP
Sterile WaterWATERBecton Dickinson and Companycab03cda-4660-4020-a3be-bf86242ff6642025-10-22Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
seebeellar antifungal cream 2% miconazoleSEEBEELLAR ANTIFUNGAL CREAM 2% MICONAZOLEGUANGZHOU YUSONG FINE CHEMICLS Co., Ltd40c491f6-43b4-534e-e063-6294a90a73d62025-10-09WarningsExact identifier
unii: VW4H1CYW1K
Xpect EyewashEYEWASHCintas Corporation1d69365d-662b-4248-8fa9-1629451b549a2025-09-30WarningsExact identifier
unii: 059QF0KO0R
Leader Miconazole 3MICONAZOLE NITRATECardinal Health 110, LLC. dba Leader7f6df893-f404-4b2d-ab2b-696c8a2d36fa2025-09-29WarningsExact identifier
ndc (package): 0113-8123-00
rxcui: 998540
Leader Ready to Use Mineral Oil LaxativeMINERAL OILCardinal Healthb8494d02-8a7d-47b4-80b0-b8ab51b625fd2025-09-29WarningsExact identifier
unii: T5L8T28FGP
CheBoho TEA TREE ACNECHEBOHO TEA TREE ACNEOpalshi(Guangzhou)E-commerce Co. Ltd.3fc4cf84-b2da-c593-e063-6394a90abc5c2025-09-27WarningsExact identifier
unii: 059QF0KO0R
Equate Miconazole 3MICONAZOLE NITRATEWALMART INC.5ade4c65-5757-4f20-b5be-f95d86363d112025-09-23WarningsExact identifier
application number: ANDA075329
ndc (package): 79903-240-32
ndc (package): 79903-241-01
ndc (package): 0113-6650-00
ndc (product): 79903-241
rxcui: 992765
rxcui: 992766
rxcui: 998540
spl id: b6bf23ff-dff4-4734-992d-f4c62ee52cb2
spl set id: 5ade4c65-5757-4f20-b5be-f95d86363d11
Sterile WaterWATERProPharma Distribution3f2ae880-852f-b45d-e063-6394a90aa1cc2025-09-19Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Joint CareURICUM ACIDUM, ACONITUM NAP.,APIS MEL., ARNICA, ARSENICUM ALB, BELLADONNA,BENZOICUM ACIDUM, BRYONIA, CALC. CARB., CHAMOMILLA, CINCHONA, COLCHICUM, EUPATORIUM PERF., GAULTHERIAPROCUMBENS, GUAIACUM, IODIUM, KALI BIC, KALMIA,LEDUM, PULSATILLA, RHUS TOXICODENDRON, RUTA,SABINA, STRYCHNINUM, LAPPA, PHYTOLACCA, SYMPHYTUM,Newton Laboratories, Inc.3f2b75d8-89f1-8d67-e063-6294a90a01662025-09-19WarningsExact identifier
unii: 8SKN0B0MIM
Equaline Miconazole 3MICONAZOLE NITRATEUnited Natural Foods, Inc. dba UNFI89328324-72d9-4b3d-bec7-cc2e4e62f0342025-09-18WarningsExact identifier
application number: ANDA075329
rxcui: 992765
rxcui: 992766
rxcui: 998540
miconazole 3 dayMICONAZOLE NITRATEPublix Super Markets Inc9ff23f06-e97f-46ad-8601-97ca05c260a02025-09-16WarningsExact identifier
application number: ANDA075329
rxcui: 992765
rxcui: 992766
rxcui: 998540

Reported adverse events (FAERS/openFDA)#

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