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 12 of 19 · 364 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PhysiciansCare Ophthalmic Solution EyewashPURIFIED WATER 98.3%Acme United Corporationcca454e0-b2bd-4215-bc06-426fcc3f7bd62024-11-26WarningsExact identifier
unii: 059QF0KO0R
PhysiciansCare Ophthalmic Solution EyewashPURIFIED WATER 98.3%Acme United Corporationd3812fa3-9334-464d-b50c-98548ff767272024-11-26WarningsExact identifier
unii: 059QF0KO0R
DANGTTEOLMINERAL WATERAQBC CO., LTD27db14a9-3812-433f-e063-6394a90a11e72024-11-26WarningsExact identifier
unii: 059QF0KO0R
4718 Enema, Mineral Oil4718 ENEMA, MINERAL OILDynarex9e51c852-9477-5cf5-e053-2a95a90a97db2024-11-20WarningsExact identifier
unii: T5L8T28FGP
Crane Safety Eye WashWATER SOLUTIONCrane Safety LLC96d8dda9-6cd6-3f68-e053-2995a90a0da22024-11-08WarningsExact identifier
unii: 059QF0KO0R
RUGBY EYE WASHWATER, PURIFIEDA-S Medication Solutions0773e558-2f46-494c-888a-3bc517202b652024-11-08WarningsExact identifier
unii: 059QF0KO0R
signature care hemorrhoidalMINERAL OIL, PETROLATUM, PHENYLEPHRINE HCLSafewayafcf68cf-f187-44d3-ad91-b1e79b182bc62024-10-17WarningsExact identifier
unii: T5L8T28FGP
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.9aa060f1-f8f6-46e6-a7d0-bd46a73f26762024-10-17WarningsExact identifier
unii: 8SKN0B0MIM
hemorrhoidalMINERAL OIL, PETROLATUM, PHENYLEPHRINE HCLMeijer Distribution Inc14319ba4-3bce-497c-a380-65bd24defc5d2024-10-17WarningsExact identifier
unii: T5L8T28FGP
Equate HemorrhoidalMINERAL OIL, PETROLATUM, PHENYLEPHRINE HCLWal-Mart Stores Inc81ecb091-38da-4b3e-a0a1-b4986b97ee092024-10-16WarningsExact identifier
unii: T5L8T28FGP
HemorrhoidalMINERAL OIL, PETROLATUM, PHENYLEPHRINE HCLKroger Company5c81d564-f786-46e1-af8b-f47521fbae602024-10-16WarningsExact identifier
unii: T5L8T28FGP
topcare hemorrhoidalMINERAL OIL, PETROLATUM, PHENYLEPHRINE HCLTopco Associates LLC615e87e4-79e0-44d6-b563-3bcd5a9b2d932024-10-16WarningsExact identifier
unii: T5L8T28FGP
Basic Care HemorrhoidalMINERAL OIL, PETROLATUM, PHENYLEPHRINE HCLAmazon.com Services LLCfe675174-fc95-4dd7-bd39-c209c6ce0f6c2024-10-16WarningsExact identifier
unii: T5L8T28FGP
EyS Eye WashWATEREyes-Plus LLC1443f6bf-3a77-4a19-8585-0ec58efe042f2024-10-15WarningsExact identifier
unii: 059QF0KO0R
Eye WashWATER SOLUTIONKroger Company354402ad-581d-47e7-9fd3-933bef281ff42024-10-11WarningsExact identifier
unii: 059QF0KO0R
Eye WashWATERHubei Changjian Medical Products Co., Ltd.d57e1c5b-1edc-4a94-88bc-f9ecf347b7ea2024-10-11WarningsExact identifier
unii: 059QF0KO0R
Soothe Night TimeWHITE PETROLATUM MINERAL OILBausch & Lomb Incorporated638d3c3f-9960-43da-956e-0e28c77f533e2024-09-24WarningsExact identifier
unii: T5L8T28FGP
Soothe XP Preservative FreeLIGHT MINERAL OIL AND MINERAL OILBausch & Lomb Incorporatedb254d885-6d49-4c95-b6be-cfdad49c85e62024-09-20WarningsExact identifier
unii: T5L8T28FGP
Soothe XPLIGHT MINERAL OIL AND MINERAL OILBausch & Lomb Incorporatedc0f053da-8d22-433e-a36e-79cf15ad387f2024-09-20WarningsExact identifier
unii: T5L8T28FGP
Dairy Allergen MixADENOSINUM TRIPHOSPHORICUM DINATRUM, BENZOICUM ACIDUM, CHOLINUM, CINNAMIC ACID, EUGENOL, FOLIC ACID, FORMALINUM, HISTAMINUM HYDROCHLORICUM, L-ASPARAGINE (MONOHYDRATE), LAC DEFLORATUM, LAC VACCINUM, MENADIONE, OOPHORINUM (SUIS), PETROSELINUM SATIVUM, PHENYL ISOTHIOCYANATE, QUERCETIN, RUTIN, SACCHARUM LACTIS, ILEUM (SUIS), JEJUNUM (SUIS), STOMACH (SUIS), COUMARINUM, FOLLICULINUM, GABA (GAMMA-AMINOBUTYRIC ACID), SARCOLACTICUM ACIDUM, LAC CANINUM, LAC FELINUM, LAC HUMANUM, PIPERINE, CALCAREA CARBONICA,Deseret Biologicals, Inc.e03d8463-287a-4509-a9f4-0ad38a98377c2024-09-11WarningsExact identifier
unii: 8SKN0B0MIM

Reported adverse events (FAERS/openFDA)#

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