FDA.reportPublic FDA data

NDC 51672-2001-01 - Miconazole Nitrate

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
51672-2001
Requested NDC
51672-2001-01
Package NDCs from labels
51672-2001-1, 51672-2001-2, 51672-2001-01
Manufacturer
Sun Pharmaceutical Industries, Inc. | Sun Pharma Canada Inc.
Effective date
2026-08-25
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Miconazole NitrateSun Pharmaceutical Industries, Inc. | Sun Pharma Canada Inc.2026-08-25HUMAN OTC DRUG LABEL
Miconazole Nitrate - A-S Medication SolutionsA-S Medication Solutions2025-12-03HUMAN OTC DRUG LABEL
Miconazole Nitrate - A-S Medication SolutionsA-S Medication Solutions2025-02-24HUMAN OTC DRUG LABEL
Miconazole NitrateNuCare Pharmaceuticals,Inc.2022-03-15HUMAN OTC DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51672-2001-1Miconazole Nitrate1 in 1 CARTONCREAM15
51672-2001-1Miconazole Nitrate15 g in 1 TUBECREAM155
51672-2001-2Miconazole Nitrate1 in 1 CARTONCREAM15
51672-2001-2Miconazole Nitrate30 g in 1 TUBECREAM305

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51672-2001MICONAZOLE NITRATE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]4Current NDC, Legacy NDC, 4 package rows20241222_7fd4037e-d350-47b7-a7d9-a43b8e366fa0.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51672-2001-1GM - Gram51672-20019dbd7e37-8219-4939-b49c-0359e914af9712012-07-24
51672-2001-2GM - Gram51672-20019cf50338-1157-450f-91bd-7c055b0d494812013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Miconazole NitrateACTIVE INGREDIENTVW4H1CYW1KMICONAZOLE NITRATE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]2
MiconazoleACTIVE MOIETY7NNO0D7S5MMICONAZOLE NITRATE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]2
apricot kernel oilINACTIVE INGREDIENT54JB35T06AMICONAZOLE NITRATE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]2
benzoic acidINACTIVE INGREDIENT8SKN0B0MIMMICONAZOLE NITRATE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]2
butylated hydroxytolueneINACTIVE INGREDIENT1P9D0Z171KMICONAZOLE NITRATE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]2
glycol stearateINACTIVE INGREDIENT0324G66D0EMICONAZOLE NITRATE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]2
mineral oilINACTIVE INGREDIENTT5L8T28FGPMICONAZOLE NITRATE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]2
PEG-32 stearateINACTIVE INGREDIENT33GX5WQC0MMICONAZOLE NITRATE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]2
PEG-6 stearateINACTIVE INGREDIENT8LQC57C6B0MICONAZOLE NITRATE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]2
polyethylene glycol 300INACTIVE INGREDIENT5655G9Y8AQMICONAZOLE NITRATE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]2
waterINACTIVE INGREDIENT059QF0KO0RMICONAZOLE NITRATE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]2

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 70 of 70 · 1,400 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sciatica-Back CareACONITUM NAP., AMMONIUM BENZOICUM, ARSENICUM ALB., BENZOICUM ACIDUM, BRYONIA, CAUSTICUM, CINCHONA, COLCHICUM, GNAPHALIUM POLYCEPHALUM, IRIS VERSICOLOR, KALI IOD., LEDUM, LITHIUM CARB., NUX VOM., PHYTOLACCA, RHUS TOXICODERON, RUTA, SAMBUCUS NIG., STRYCHNINUM, HYPERICUM, URTICA URNewton Laboratories, Inc.99ea75a9-3250-281b-e053-2a95a90aed452020-12-07WarningsExact identifier
unii: 8SKN0B0MIM
Tobacco WithdrawalARSENICUM ALB., BENZOICUM ACIDUM, BERBER. VULG., BRYONIA, CALADIUM SEGUINUM, CANTHARIS, CEANOTHUS, CHELIDONIUM MAJUS, CHIONANTHUS VIRGINICA, CINCHONA, DAPHNE INDICA, IGNATIA, IRIS VERSICOLOR, LYCOPODIUM, NICOTINUM, NUX VOM., RHUS TOXICODENDRON, SCUTELLARIA LATERIFLORA, TABACUM, ECHINACEA, TARAXACUM, VALERIANANewton Laboratories, Inc.99eda7db-ce40-446f-e053-2995a90a95aa2020-12-07WarningsExact identifier
unii: 8SKN0B0MIM
Lymphatic DrainerECHINACEA, SOLIDAGO, TARAXACUM, ASTERIAS, AUR. MET., BELLADONNA, BENZOICUM AC., BERBER. VULG., BRYONIA, CALC. CARB., CANTHARIS, CARDUUS MAR., CEANOTHUS, CHELIDONIUM MAJ., CHIONANTHUS, CINCHONA, DIOSCOREA, IRIS VERS., NAT. CARB., NUX VOM., PTELEA..Newton Laboratories, Inc.9a633bfa-188c-dd42-e053-2995a90ad3aa2020-12-04WarningsExact identifier
unii: 8SKN0B0MIM
DrainerCYNARA SCOLYMUS, SOLIDAGO VIRGAUREA, TARAXACUM OFFICINALE, BENZOICUM ACIDUM, BERBERIS VULGARIS, BRYONIA, CANTHARIS, CARDUUS BENEDICTUS, CARDUUS MARIANUS, CEANOTHUS AMERICANUS, CHELIDONIUM MAJUS, CHIONANTHUS VIRGINICA, CINCHONA OFFICINALIS, DIOSCOREA VILLOSA, DOLICHOS PRURIENS, IRIS VERSICOLOR, JUNIPERUS COMMUNIS, NUX VOMICA, PTELEA TRIFOLIATA, TARAXACUM OFFICINALE, URICUM.Newton Laboratories, Inc.9a008b9f-5db5-fac0-e053-2995a90a17c62020-12-02WarningsExact identifier
unii: 8SKN0B0MIM
DetoxifierURICUM ACIDUM, BENZOICUM ACIDUM, BERBER. VULG., BRYONIA, CANTHARIS, CARDUUS BENEDICTUS, CEANOTHUS, CHELIDONIUM MAJUS, CHIONANTHUS VIRGINICA, CINCHONA, DIOSCOREA, DOLICHOS, IRIS VERSICOLOR, JUNIPERUS COM., NUX VOM.,PTELEA,TARAXACUM, CARDUUS MAR., CYNARA SCOLYMUS, SOLIDAGONewton Laboratories, Inc.92ad49e0-2cfe-7d51-e053-2995a90a16f52020-11-24WarningsExact identifier
unii: 8SKN0B0MIM
Miconazole NitrateMICONAZOLE NITRATEActavis Pharma, Inc.aa9e250b-f317-42cb-b8d2-e85de56f4ef72020-10-21Adverse reactionsExact identifier
unii: VW4H1CYW1K
Bach Original Flower RemediesWATERNelson Bach USA Limited09c76050-42c5-4403-865c-a1f6f668d9c02020-06-15WarningsExact identifier
unii: 059QF0KO0R
DrainageCYNARA SCOLYMUS, SOLIDAGO VIRGAUREA, TARAXACUM OFFICINALE, BENZOICUM ACIDUM, BERBERIS VULGARIS, BRYONIA, CANTHARIS, CARDUUS BENEDICTUS, CARDUUS MARIANUS, CEANOTHUS AMERICANUS, CHELIDONIUM MAJUS, CHIONANTHUS VIRGINICA, CINCHONA OFFICINALIS, DIOSCOREA VILLOSA, DOLICHOS PRURIENS, IRIS VERSICOLOR, JUNIPERUS COMMUNIS, NUX VOMICA, PTELEA TRIFOLIATA, TARAXACUM OFFICINALE, URICUM.Xymogena526f4ac-1630-c122-e053-2995a90a6a272020-05-08WarningsExact identifier
unii: 8SKN0B0MIM
Sterile WaterWATERBaxter Healthcare Company8bcf5572-49e1-4302-9522-56f57904cb4a2019-12-29Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
GUNA-DIZZY.ALPHA.-KETOGLUTARIC ACID - AMBERGRIS - ANAMIRTA COCCULUS SEED - CONIUM MACULATUM FLOWERING TOP - EPINEPHRINE - FUMARIC ACID - MALIC ACID - MELATONIN - MINERAL OIL - PTERIDIUM AQUILINUM ROOT - PYRIDOXINE HYDROCHLORIDE - QUINHYDRONE - QUININE - SUS SCROFA ARTERY - SUS SCROFA CEREBELLUM - SUS SCROFA PLACENTA - THIAMINE HYDROCHLORIDE - TOBACCO LEAF -Guna spac5f4a798-e628-4388-a98d-7449dd92f2d62018-12-21WarningsExact identifier
unii: T5L8T28FGP
Dynamic Eyewash with EyecupWATERDynamic Safety International7d3af0f4-0e1f-9ea5-e053-2991aa0af7a22018-12-17WarningsExact identifier
unii: 059QF0KO0R
VUSIONMICONAZOLE NITRATE, ZINC OXIDE, WHITE PETROLATUMMylan Pharmaceuticals Inc.b44b452d-3630-4cb5-8ed1-1f8edac4690c2018-08-15Warnings, Adverse reactionsExact identifier
unii: VW4H1CYW1K
VUSIONMICONAZOLE NITRATE, ZINC OXIDE, WHITE PETROLATUMMylan Pharmaceuticals Inc.b026bc7d-3a18-41e8-88c4-1e063cd2f42c2018-08-14Warnings, Adverse reactionsExact identifier
unii: VW4H1CYW1K
Bio Rock WaterROCK WATERBioActive Nutritional, Inc.178bd16d-0d4f-49d8-866b-8ab3a3c6889d2018-07-30WarningsExact identifier
unii: 059QF0KO0R
Homeoplex DGLYCERINUM, PHYTOLACCA DECANDRA, TARAXACUM OFFICINALE, ARSENICUM ALBUM, NITRICUM ACIDUM, NUX VOMICA, PETROLEUM, PHOSPHORICUM ACIDUM, PHOSPHORUS, ACETYLSALICYLICUM ACIDUM, GLONOINUM, INSULINUM (SUIS), LITHIUM CARBONICUM, THYROIDINUM (SUIS), SALICYLICUM ACIDUM, ADRENOCORTICOTROPHIN, CORTISONE ACETICUM, EUGENOL, STEARYL ALCOHOL, XYLITOL, FOLLICULINUM, BENZOICUM ACIDUM, CHLORINUM, POTASSIUM SORBATE, SORBITOL, RESORCINUM, BENZYL ALCOHOL, LACTICUM ACIDUM, ISOPROPYL PALMITATE, BORICUM ACIDUM, ACETICUM ACIDUM,Supplement Clinic, LLC.cd6b48ab-3566-484d-8deb-15ef6f8e7e8f2017-11-01WarningsExact identifier
unii: 8SKN0B0MIM
Sterile WaterWATERBaxter Healthcare Corporationef3e79c5-3f58-4b36-a296-64b7d9a651c12017-10-17Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Eye WashWATERCVS Pharmacy049cee29-7ec2-4d5b-8308-f522acde43a72017-03-29WarningsExact identifier
unii: 059QF0KO0R
Tox-ChordALFALFA, ALUMINA, BENZOICUM ACIDUM, CARBONEUM, CETRARIA ISLANDICA, FOLLICULINUM, FUCUS VESICULOSUS, FUMARICUM ACIDUM, HEPAR SUIS, KALI CARBONICUM, KREOSOTUM, NATRUM MURIATICUM, PARAFFINUM, PETROLEUM, PHOSPHORICUM ACIDUM, PHOSPHORUS, PIX LIQUIDA, PLANTAGO MAJOR, PLUMBUM METALLICUM, PULSATILLA (VULGARIS), RADIUM BROMATUM, RESORCINUM, SALOL, SILICEA, SYMPHYTUM OFFICINALE, TABACUM, TEREBINTHINA, THYROIDINUM (BOVINE), TRITICUM REPENS, ZINCUM OXYDATUMEnergetix Corp6b0d1628-b20d-426e-9c84-5cceadca3f452016-11-11WarningsExact identifier
unii: 8SKN0B0MIM
Sterile WaterWATERBaxter Healthcare Company210dc9ab-d6ca-4552-ac19-1be17792d2902016-05-31Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
MicatinMICONAZOLE NITRATEWellSpring Pharmaceutical Corporation96c56ba1-c3a8-48ce-ab58-550959485e3c2016-04-07WarningsExact identifier
application number: M005
rxcui: 998483
unii: VW4H1CYW1K

Reported adverse events (FAERS/openFDA)#

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