FDA.reportPublic FDA data

NDC 63629-8646-01 - 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
63629-8646
Requested NDC
63629-8646-01
Package NDCs from labels
63629-8646-1, 63629-8646-01
Manufacturer
Bryant Ranch Prepack
Effective date
2024-01-11
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Econazole Nitrate - Bryant Ranch PrepackBryant Ranch Prepack2024-01-11HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63629-8646-1Econazole Nitrate1 in 1 CARTONCREAM1105
63629-8646-1Econazole Nitrate30 g in 1 TUBECREAM30105

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-8646ECONAZOLE NITRATE CREAM [BRYANT RANCH PREPACK]105Current NDC, Legacy NDC, 2 package rows20240814_4ac65707-a8b2-45de-a3c6-89e3ea845124.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-8646-1GM - Gram63629-86465417826a-67ef-4d6e-9f62-2e9dbb63970012021-10-08

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 9 of 19 · 361 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hemorrhoidal Pain ReliefHEMORRHOIDAL PAIN RELIEF OINTMENTNeilmed Pharmaceuticals Inc.374d89b6-9305-9adf-e063-6394a90adb322025-06-11WarningsExact identifier
unii: T5L8T28FGP
HemorrhoidalOintmentMINERAL OIL, PETROLATUM, PHENYLEPHRINE HCITrifecta Pharmaceuticals USA LLC4eb3c9ac-268a-5246-e054-00144ff88e882025-06-09WarningsExact identifier
unii: T5L8T28FGP
Econazole NitrateECONAZOLE NITRATEPreferred Pharmaceuticals Inc.2bd2a48e-cbef-4b14-a02f-9aa693cc4b472025-06-02Warnings, Adverse reactionsExact identifier
application number: ANDA076479
rxcui: 857366
unii: H438WYN10E
Sterile WaterWATERHenry Schein, Inc.88403fcf-a276-42c0-88b6-bd84a720b5642025-05-29Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Mineral OilMINERAL OILATLANTIC BIOLOGICALS CORP.960502ae-2468-406e-8799-cacb01f2727e2025-05-23WarningsExact identifier
unii: T5L8T28FGP
Eyesaline Emergency EyewashSTERILE EYESALINE EYEWASHHoneywell Safety Products USA, Inc.2d567518-4c54-7448-e063-6294a90a3e642025-05-14WarningsExact identifier
unii: 059QF0KO0R
Mineral OilMINERAL OILAmerisourceBergen (Good Neighbor Pharmacy) 46122581f81a0-7488-4c90-b33e-06c6301a4fd22025-04-17WarningsExact identifier
unii: T5L8T28FGP
Eye WashWATERCMC Group Inc.6158a1f5-a6bc-4a3e-9d1d-0a310d9dc5612025-04-02WarningsExact identifier
unii: 059QF0KO0R
hemorrhoidalMINERAL OIL, PETROLATUM, PHENYLEPHRINE HCLBionpharma Inc.1790da99-2a22-e2a2-e063-6394a90ac36f2025-03-31WarningsExact identifier
unii: T5L8T28FGP
Dr. Butler Hemorrhoid and PerinealMINERAL OIL 59.8%,PETROLATUM 36%Beyond Health P.A.d17b6f16-6893-ce0a-e053-2a95a90aa23a2025-03-19WarningsExact identifier
unii: T5L8T28FGP
Mineral OilMINERAL OILKesin Pharma Corporation30a11cc9-e407-23b7-e063-6294a90a7d6e2025-03-18WarningsExact identifier
unii: T5L8T28FGP
Bestmade Natural Products BM230ACID BENZ, CIMICIFUGA, COLCHICUM, LEDUM, PULSATILLA, RUTA GR, CALC PHOSBestmade Natural Products2f80cfae-5f8c-7cbf-e063-6394a90a43fd2025-03-04WarningsExact identifier
unii: 8SKN0B0MIM
AeroWash EyewashEYEWASH SOLUTIONAero Healthcare US LLCa477de08-4301-0ee5-e053-2995a90af79d2025-02-26WarningsExact identifier
unii: 059QF0KO0R
Mineral oilMINERAL OILP & L Development, LLC68e88119-1468-4ab7-a5fa-242d960d25df2025-02-21WarningsExact identifier
unii: T5L8T28FGP
Bestmade Natural Products BM184BENZOIC ACID, BUCHU, BELLADONNA, TEREBINTHINA, THLAPSI B.P, TRITICUM REPBestmade Natural Products2e9211e3-0e20-741e-e063-6394a90a4da12025-02-20WarningsExact identifier
unii: 8SKN0B0MIM
Bestmade Natural Products BM151BELLADONNA, BENZOIC ACID, CAUSTICUM, EQUISETUM, GELSEMIUM, RHUS AROM, VERBASCUMBestmade Natural Products2e6a469d-026f-41b0-e063-6394a90abd792025-02-18WarningsExact identifier
unii: 8SKN0B0MIM
Advanced Eye Relief Eye WashWATER SOLUTIONBausch & Lomb Incorporated9caccce1-4530-441d-bf76-244edeb9dedc2025-02-17WarningsExact identifier
unii: 059QF0KO0R
Sciatica-Nerve 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.9cbd3056-3c1a-916d-e053-2a95a90aa2432025-02-10WarningsExact identifier
unii: 8SKN0B0MIM
Sciatica-Nerve 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.9cbda496-ef30-18af-e053-2995a90a23212025-02-10WarningsExact 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.9d38fd5a-1657-11e5-e053-2a95a90a47ee2025-02-10WarningsExact identifier
unii: 8SKN0B0MIM

Reported adverse events (FAERS/openFDA)#

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