FDA.reportPublic FDA data

NDC 51672-1303-01 - Econazole 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
51672-1303
Requested NDC
51672-1303-01
Package NDCs from labels
51672-1303-1, 51672-1303-2, 51672-1303-8, 51672-1303-01
Manufacturer
Preferred Pharmaceuticals Inc.
Effective date
2026-04-10
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Econazole Nitrate Cream 1%Preferred Pharmaceuticals Inc.2026-04-10HUMAN PRESCRIPTION DRUG LABEL
Econazole Nitrate Cream 1%Sun Pharmaceutical Industries, Inc. | Sun Pharma Canada Inc.2025-08-26HUMAN PRESCRIPTION DRUG LABEL
Econazole Nitrate - RedPharm DrugRedPharm Drug2024-07-15HUMAN PRESCRIPTION DRUG LABEL
Econazole Nitrate - Aidarex Pharmaceuticals LLCAidarex Pharmaceuticals LLC2013-12-30HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51672-1303-1Econazole Nitrate15 g in 1 TUBECREAM158
51672-1303-1Econazole Nitrate1 in 1 CARTONCREAM18
51672-1303-2Econazole Nitrate30 g in 1 TUBECREAM308
51672-1303-2Econazole Nitrate1 in 1 CARTONCREAM18
51672-1303-8Econazole Nitrate85 g in 1 TUBECREAM858
51672-1303-8Econazole Nitrate1 in 1 CARTONCREAM18

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51672-1303ECONAZOLE NITRATE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]6Current NDC, Legacy NDC, 6 package rows20241222_90c40d7f-94fa-440c-9815-30378f76ae79.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51672-1303-1GM - Gram51672-13037c2f8038-50f5-484d-8a13-081c36b4b1e212013-02-13
51672-1303-2GM - Gram51672-130337ad2634-e132-4208-83fe-215a91fcb47712013-02-13
51672-1303-8GM - Gram51672-13035737f6b6-4d86-4315-a8e4-381f0486997312013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Econazole NitrateACTIVE INGREDIENTH438WYN10EECONAZOLE NITRATE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]3
EconazoleACTIVE MOIETY6Z1Y2V4A7MECONAZOLE NITRATE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]3
apricot kernel oil PEG-6 estersINACTIVE INGREDIENTDRG3KJZ1TJECONAZOLE NITRATE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]3
benzoic acidINACTIVE INGREDIENT8SKN0B0MIMECONAZOLE NITRATE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]3
butylated hydroxytolueneINACTIVE INGREDIENT1P9D0Z171KECONAZOLE NITRATE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]3
glycol stearateINACTIVE INGREDIENT0324G66D0EECONAZOLE NITRATE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]3
mineral oilINACTIVE INGREDIENTT5L8T28FGPECONAZOLE NITRATE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]3
PEG-32 stearateINACTIVE INGREDIENT33GX5WQC0MECONAZOLE NITRATE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]3
PEG-6 stearateINACTIVE INGREDIENT8LQC57C6B0ECONAZOLE NITRATE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]3
waterINACTIVE INGREDIENT059QF0KO0RECONAZOLE NITRATE CREAM [TARO PHARMACEUTICALS U.S.A., INC.]3
ECONAZOLE NITRATEACTIVE INGREDIENTH438WYN10EECONAZOLE NITRATE CREAM [AIDAREX PHARMACEUTICALS LLC]1
ECONAZOLEACTIVE MOIETY6Z1Y2V4A7MECONAZOLE NITRATE CREAM [AIDAREX PHARMACEUTICALS LLC]1
APRICOT KERNEL OIL PEG-6 ESTERSINACTIVE INGREDIENTDRG3KJZ1TJECONAZOLE NITRATE CREAM [AIDAREX PHARMACEUTICALS LLC]1
BENZOIC ACIDINACTIVE INGREDIENT8SKN0B0MIMECONAZOLE NITRATE CREAM [AIDAREX PHARMACEUTICALS LLC]1
BUTYLATED HYDROXYTOLUENEINACTIVE INGREDIENT1P9D0Z171KECONAZOLE NITRATE CREAM [AIDAREX PHARMACEUTICALS LLC]1
GLYCOL STEARATEINACTIVE INGREDIENT0324G66D0EECONAZOLE NITRATE CREAM [AIDAREX PHARMACEUTICALS LLC]1
MINERAL OILINACTIVE INGREDIENTT5L8T28FGPECONAZOLE NITRATE CREAM [AIDAREX PHARMACEUTICALS LLC]1
PEG-32 STEARATEINACTIVE INGREDIENT33GX5WQC0MECONAZOLE NITRATE CREAM [AIDAREX PHARMACEUTICALS LLC]1
PEG-6 STEARATEINACTIVE INGREDIENT8LQC57C6B0ECONAZOLE NITRATE CREAM [AIDAREX PHARMACEUTICALS LLC]1
WATERINACTIVE INGREDIENT059QF0KO0RECONAZOLE NITRATE CREAM [AIDAREX PHARMACEUTICALS LLC]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 19 · 364 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CVS Mineral OilMINERAL OILCVS9d7402e1-524b-1084-e053-2a95a90ae3af2023-12-20WarningsExact identifier
unii: T5L8T28FGP
Humco Mineral Oil HeavyMINERAL OILHumco Holding Group, Inc.9f943fdf-5058-4e18-ba96-6be112bf72ca2023-12-15WarningsExact identifier
unii: T5L8T28FGP
Humco Mineral Oil LightMINERAL OILHumco Holding Group, Inc.753f35c3-1420-4817-ba63-b737a9c99a1d2023-12-15WarningsExact identifier
unii: T5L8T28FGP
AltalubeMINERAL OIL AND PETROLATUMAltaire Pharmaceuticals Inc.eb65004c-c3a7-4079-bd75-f2857d30c68a2023-12-09WarningsExact identifier
unii: T5L8T28FGP
Hemorrhoidal Pain ReliefMINERAL OIL, PETROLATUM, PHENYLEPHRINE HCLWALGREENS03bc5c1a-d493-5082-e063-6394a90ae87b2023-12-05WarningsExact identifier
unii: T5L8T28FGP
Eye WashWATERJiangxi Zhenmei Biological Technology Co.,Ltdc68795b8-bf68-0d01-e053-2a95a90abebb2023-12-04WarningsExact identifier
unii: 059QF0KO0R
EcozaECONAZOLE NITRATEResilia Pharmaceuticals, Inc.0bb5fa27-32ed-ed13-e063-6394a90a15772023-12-04Warnings, Adverse reactionsExact identifier
unii: H438WYN10E
Econazole NitrateECONAZOLE NITRATEPadagis Israel Pharmaceuticals Ltd3acc5e03-0339-4b23-945d-641746e819232023-11-30Warnings, Adverse reactionsExact identifier
rxcui: 857366
unii: H438WYN10E
Family wellnessMINERAL OIL, PETROLATUM, PHENYLEPHRINE HCLFRONT PHARMACEUTICAL PLCcfdd61e3-e12e-491c-b2a8-90fae19e88702023-10-27WarningsExact identifier
unii: T5L8T28FGP
FLEETMINERAL OILC.B. Fleet Company, Inc.2528cb5e-437e-41f0-9c34-e9ce57404d8b2023-10-26WarningsExact identifier
unii: T5L8T28FGP
Family WellnessPHENYLEPHRINE HCL, PETROLATUM, MINERALZhejiang Jingwei Pharmaceutical Co., Ltd.bfa195d7-d87f-43b5-bbf1-7ec3a451de052023-10-25WarningsExact identifier
unii: T5L8T28FGP
TheraPlus PlusPHENYLEPHRINE HCIZhejiang Jingwei Pharmaceutical Co., Ltd.edf9f8d5-f55d-4c31-adfb-ba77ca24cc3d2023-10-25WarningsExact identifier
unii: T5L8T28FGP
Uric Acid BalancerDULCAMARA, LEDUM PALUSTRE, ARNICA MONTANA, BENZOICUM ACIDUM, BRYONIA (ALBA), COLCHICUM AUTUMNALE, LITHIUM CARBONICUM, NATRUM PHOSPHORICUM, URTICA URENS, FORMICA RUFA, LYCOPODIUM CLAVATUMNutritional Specialties, Inc.f46c8203-4022-4240-bb45-2a3a8a318eae2023-10-04WarningsExact identifier
unii: 8SKN0B0MIM
CardCareECHINACEA, HYPERICUM, VALERIANA, ACONITUM NAP., ARSENICUM ALB., AUR. MET., BARYTA CARB., BENZOICUM AC., BERBER. VULG., BRYONIA, CALC. FLUOR., CANTHARIS, CEANOTHUS, CHELIDONIUM MAJ., CHIONANTHUS, CINCHONA, CONVALLARIA, CROTALUS HOR., DIGITALIS, GELSEMIUM, GLONOINUM, HYDROFLUORICUM AC. KALI IOD., LACHESIS, LYCOPUS, NAJA, NUX VOM., PHOS., PULSATILLA, RHUS TOX., VIPERA, ELAPS.Newton Laboratories, Inc.06342201-f0b4-de0d-e063-6294a90a56212023-09-25WarningsExact identifier
unii: 8SKN0B0MIM
ANUBISMEDHA HYALURONICANUBIS COSMETICS SLeac771e2-4c1b-3808-e053-2995a90ac5fc2023-09-05WarningsExact identifier
unii: 1P9D0Z171K
unii: 059QF0KO0R
AnubisMedSPF 50 BROAD SPECTRUM PROTECTION FLUID EMULSIONANUBIS COSMETICS SLe99d92c4-8768-9c0a-e053-2a95a90a609e2023-09-05WarningsExact identifier
unii: 1P9D0Z171K
unii: 059QF0KO0R
AnubisMedAZELAIC ACID, SALICYLIC ACIDANUBIS COSMETICS SLebf3153d-30f5-54e4-e053-2995a90a74b12023-09-05WarningsExact identifier
unii: 059QF0KO0R
AnubisMedGLYCOLIC ACID, CITRIC ACID, LACTIC ACID, KOJIC ACIDANUBIS COSMETICS SLeca95dde-cb57-2ab6-e053-2995a90af84f2023-09-05WarningsExact identifier
unii: 059QF0KO0R
AnubisMedSODIUM BICARBONATE, ALOE BARBADENSIS LEAF JUICE, IMIDAZOLIDINYL UREAANUBIS COSMETICS SLebf4b3ab-34e1-185a-e053-2a95a90ace3a2023-09-05WarningsExact identifier
unii: 059QF0KO0R
LipotoxSQUALENE, CHOLESTERINUM, ESTRADIOL, PROGESTERONE, ASPARTAME, BENZALKONIUM CHLORIDE, FORMALINUM, METHYLENE CHLORIDE, METHYLPARABEN, PROPYLPARABEN, SODIUM BENZOATE, SODIUM CITRATE, TITANIUM DIOXIDE, ZINCUM OXYDATUM, ARSENICUM ALBUM, LYCOPODIUM CLAVATUM, NUX VOMICA, PHOSPHORICUM ACIDUM, PHOSPHORUS, ACETICUM ACIDUM, BENZOICUM ACIDUM, BENZYL ALCOHOL, BORICUM ACIDUM, CHLORINUM, CORTISONE ACETICUM, EUGENOL, FOLLICULINUM, ISOPROPYL PALMITATE, LACTICUM ACIDUM, PETROLEUM JELLY, PHENYL BUTAZONE, PLUMBUM METALLICUM,BioActive Nutritional, Inc.a1538692-ca00-4e52-9b7e-409767ee27e12023-09-05WarningsExact identifier
unii: 8SKN0B0MIM

Reported adverse events (FAERS/openFDA)#

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