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 6 of 19 · 367 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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
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
Firstep FirstflushEYEWASHEncon Safety Products, Inc.a44beb26-79ae-98bd-e053-2995a90a9b742025-12-09WarningsExact identifier
unii: 059QF0KO0R
CAREALL HemorrhoidalMINERAL OIL, PETROLATUM, PHENYLEPHRINE HCLNew World Imports, Inc7913bd41-a606-4ca6-b69f-2717c2f54b072025-12-01WarningsExact identifier
unii: T5L8T28FGP
HOEGOA Hair Scalp Sunscreen MineralTITANIUM DIOXIDEGuangzhou Hoegoa Biotechnology Co., Ltd.44b37930-b302-338c-e063-6394a90a5f7f2025-11-28WarningsExact identifier
unii: T5L8T28FGP
OUHOE Biotin With Hydrolyzed CollagenGLYCERINShantou Ouhoe Technology Co., Ltd.43138915-5fe1-6e32-e063-6294a90abefa2025-11-27WarningsExact identifier
unii: T5L8T28FGP
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.99ff92f5-91bc-120b-e053-2995a90a8d8a2025-11-26WarningsExact identifier
unii: 8SKN0B0MIM
PUR-WASHWATERNiagara Pharmaceuticals Inc.beda35c3-9a8b-47ad-e053-2995a90a7b1b2025-11-24WarningsExact identifier
unii: 059QF0KO0R
Easy Care First Aid EyewashWATERTender Corporationa070aac8-e6d2-ef10-e053-2a95a90aa5b12025-11-24WarningsExact identifier
unii: 059QF0KO0R
PUR-WASHWATERNiagara Pharmaceuticals Inc.e07a064b-f680-405c-bbcd-24fac430951e2025-11-24WarningsExact identifier
unii: 059QF0KO0R
ULINE EyewashEYEWASHNiagara Pharmaceuticals Inc.2d7f22d2-320b-6af1-e063-6294a90addc62025-11-24WarningsExact identifier
unii: 059QF0KO0R
Pur-WashEYEWASHNiagara Pharmaceuticals, Inc.0d43b1c1-2699-37f1-e054-00144ff88e882025-11-24WarningsExact identifier
unii: 059QF0KO0R
PUR-WASHWATERNiagara Pharmaceuticals Inc.777e1559-786f-8d54-e053-2991aa0aa98d2025-11-24WarningsExact identifier
unii: 059QF0KO0R
PUR-WASHWATERNiagara Pharmaceuticals Inc.7289103a-5cbf-42f4-8848-e827149a43ca2025-11-24WarningsExact identifier
unii: 059QF0KO0R
Eyewash Additive ConcentrateWATER AND PROPYLENE GLYCOLHaws Corporationdd168403-398c-41ff-b1df-d93e4ff39de32025-11-20WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERFresenius Kabi USA, LLCfd823bef-c14c-4708-a18a-8aaa8470412f2025-11-18Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Eyesaline Eyewash ConcentratePURIFIED WATERHoneywell Safety Products USA, Inc.3765c251-eb14-d60f-e063-6294a90a6a4d2025-11-12WarningsExact identifier
unii: 059QF0KO0R
Eyesaline Emergency EyewashPURIFIED WATERHoneywell Safety Products USA, Inc.37f244fd-c02f-e66a-e063-6394a90aed812025-11-12WarningsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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