FDA.reportPublic FDA data

NDC 0591-5552 - Metronidazole

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
0591-5552
Package NDCs from labels
0591-5552-50, 0591-5552-01, 0591-5552-25, 0591-5552-05, 0591-5552-10
Manufacturer
Physicians Total Care, Inc.
Effective date
2013-07-22
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Metronidazole - Physicians Total Care, Inc.Physicians Total Care, Inc.2013-07-22HUMAN PRESCRIPTION DRUG LABEL
Metronidazole - Watson LabsWatson Labs2006-11-27HUMAN PRESCRIPTION DRUG LABELING
Metronidazole - Watson LabsWatson Labs2006-02-06HUMAN PRESCRIPTION DRUG LABELING

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0591-5552-01Metronidazole100 in 1 BOTTLETABLET1003
0591-5552-05Metronidazole500 in 1 BOTTLETABLET5003
0591-5552-10Metronidazole1000 in 1 BOTTLETABLET10003
0591-5552-25Metronidazole250 in 1 BOTTLETABLET2503
0591-5552-50Metronidazole50 in 1 BOTTLETABLET503

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0591-5552METRONIDAZOLE (METRONIDAZOLE) TABLET [WATSON LABS]35 package rows20061208_A66ABF44-9AE9-4342-B69A-EBAA1F9B7D78.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MetronidazoleACTIVE INGREDIENT140QMO216EMETRONIDAZOLE (METRONIDAZOLE) TABLET [WATSON LABS]3
metronidazoleACTIVE MOIETY140QMO216EMETRONIDAZOLE (METRONIDAZOLE) TABLET [WATSON LABS]3
Colloidial silicon dioxideINACTIVE INGREDIENTMETRONIDAZOLE (METRONIDAZOLE) TABLET [WATSON LABS]3
CrospovidoneINACTIVE INGREDIENTMETRONIDAZOLE (METRONIDAZOLE) TABLET [WATSON LABS]3
Hydrogenated vegtable oilINACTIVE INGREDIENTMETRONIDAZOLE (METRONIDAZOLE) TABLET [WATSON LABS]3
Microcrystalline celluloseINACTIVE INGREDIENTMETRONIDAZOLE (METRONIDAZOLE) TABLET [WATSON LABS]3
METRONIDAZOLEACTIVE INGREDIENT140QMO216EMETRONIDAZOLE TABLET [PHYSICIANS TOTAL CARE, INC.]2
METRONIDAZOLEACTIVE MOIETY140QMO216EMETRONIDAZOLE TABLET [PHYSICIANS TOTAL CARE, INC.]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UMETRONIDAZOLE TABLET [PHYSICIANS TOTAL CARE, INC.]2
CROSPOVIDONEINACTIVE INGREDIENT68401960MKMETRONIDAZOLE TABLET [PHYSICIANS TOTAL CARE, INC.]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4METRONIDAZOLE TABLET [PHYSICIANS TOTAL CARE, INC.]2
MetronidazoleACTIVE INGREDIENT140QMO216EMETRONIDAZOLE (METRONIDAZOLE) TABLET [WATSON LABS]1
MetronidazoleACTIVE MOIETY140QMO216EMETRONIDAZOLE (METRONIDAZOLE) TABLET [WATSON LABS]1
Colloidial silicon dioxideINACTIVE INGREDIENTMETRONIDAZOLE (METRONIDAZOLE) TABLET [WATSON LABS]1
CrospovidoneINACTIVE INGREDIENTMETRONIDAZOLE (METRONIDAZOLE) TABLET [WATSON LABS]1
Hydrogenated vegtable oilINACTIVE INGREDIENTMETRONIDAZOLE (METRONIDAZOLE) TABLET [WATSON LABS]1
Microcrystalline celluloseINACTIVE INGREDIENTMETRONIDAZOLE (METRONIDAZOLE) TABLET [WATSON LABS]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 38 of 38 · 758 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dust Mix AntigenANTIMON TART, ARSENICUM ALB, BLATTA OR, BROMIUM, CALC CARB, CIMEX, DROSERA, HEPAR SULPH CALC, ICTODES FOETIDA, LYCOPODIUM, PHOS, PULSATILLA, SILICEA TERRA, TABACUM FUMUSNatural Creations, Inc8dab4b4a-6fa8-4258-adc1-f8c634e2030b2018-12-21WarningsExact identifier
unii: ETJ7Z6XBU4
HA HPBELLADONNA, BRYONIA (ALBA), GELSEMIUM SEMPERVIRENS, GLONOINUM, MELILOTUS OFFICINALIS, NUX VOMICA, SILICEA, SPIGELIA ANTHELMIABioActive Nutritional, Inc.30f6c191-ce6e-438c-9601-74f5e8b61f962018-07-06WarningsExact identifier
unii: ETJ7Z6XBU4
Immuno FortifierECHINACEA (ANGUSTIFOLIA), HYDRASTIS CANADENSIS, LIGUSTICUM PORTERI, MYRRHA, NASTURTIUM AQUATICUM, TABEBUIA IMPETIGINOSA, TRIGONELLA FOENUM-GRAECUM, ASCORBIC ACID, PINUS SYLVESTRIS, LYMPH (SUIS), MEDULLA OSSIS SUIS, SPLEEN (SUIS), THYMUS (SUIS), HEPAR SULPHURIS CALCAREUM, PHOSPHORICUM ACIDUM, SILICEABioActive Nutritional, Inc.04024663-0b11-438a-a21a-8e86edd8052a2018-01-15WarningsExact identifier
unii: ETJ7Z6XBU4
H-Acne FormulaCALENDULA OFFICINALIS, NUX VOMICA, SILICEAHealing Natural Oils LLCfd9598ac-8f69-4fba-99c1-4234c8afcafd2017-12-27WarningsExact identifier
unii: ETJ7Z6XBU4
H-Nail Fungus FormulaCALENDULA OFFICINALIS, SILICEA, THUJA OCCIDENTALISHealing Natural Oils LLC68f87ae5-fa3a-45cf-971c-c09e98106dd82017-12-27WarningsExact identifier
unii: ETJ7Z6XBU4
Homeoplex FECHINACEA (ANGUSTIFOLIA), PHYTOLACCA DECANDRA, LYMPH NODE (SUIS), CONIUM MACULATUM, FERRUM IODATUM, HEPAR SULPHURIS CALCAREUM, KALI MURIATICUM, LACHESIS MUTUS, SILICEASupplement Clinic, LLC.a1872d34-7298-4016-b7b3-830ac11491262017-11-01WarningsExact identifier
unii: ETJ7Z6XBU4
Homeoplex PASTRAGALUS MEMBRANACEUS, ECHINACEA (ANGUSTIFOLIA), SCROPHULARIA NODOSA, TABEBUIA IMPETIGINOSA, THYROIDINUM (SUIS), FORMICUM ACIDUM, PHOSPHORUS, SILICEA, SULPHUR, THUJA OCCIDENTALIS, AURUM METALLICUMSupplement Clinic, LLC.3c0450c8-956e-4788-9e4d-55d30052ca0b2017-11-01WarningsExact identifier
unii: ETJ7Z6XBU4
PertussisACONITUM NAPELLUS, BRYONIA (ALBA), HYOSCYAMUS NIGER, IPECACUANHA, STICTA PULMONARIA, TABACUM, PHOSPHORUS, ANTIMONIUM TARTARICUM, KREOSOTUM, SILICEA, PERTUSSINUM, TETANUS TOXINDeseret Biologicals, Inc.b50b5a93-dbb5-4be9-91ac-7513f0ee34102017-10-31WarningsExact identifier
unii: ETJ7Z6XBU4
Teething-HPBORAX, CALCAREA CARBONICA, CALCAREA PHOSPHORICA, CHAMOMILLA, PASSIFLORA INCARNATA, PODOPHYLLINUM, SILICEABioActive Nutritional, Inc.1758624d-7ed8-49a6-ab24-2aab57703c912017-06-16WarningsExact identifier
unii: ETJ7Z6XBU4
ParathyroplexPARATHYROID GLAND (BOVINE), BARYTA CARBONICA, CALCAREA CARBONICA, CALCAREA FLUORICA, CALCAREA PHOSPHORICA, CUPRUM METALLICUM, MAGNESIA PHOSPHORICA, MANGANUM METALLICUM, RHUS TOX, SILICEABioActive Nutritional, Inc.37649bb9-cbd7-4971-b410-18ea307c46f62017-04-18WarningsExact identifier
unii: ETJ7Z6XBU4
Arthritis JointsGNAPHALIUM POLYCEPHALUM, BERBERIS VULGARIS, CIMICIFUGA RACEMOSA, CINCHONA OFFICINALIS, COLOCYNTHIS, LEDUM PALUSTRE, RANUNCULUS BULBOSUS, AESCULUS HIPPOCASTANUM, BORAX, CUPRUM ACETICUM, KALI CARBONICUM, PULSATILLA (VULGARIS), SECALE CORNUTUM, AMMONIUM MURIATICUM, SILICEA, ARGENTUM METALLICUM, CALCAREA PHOSPHORICA, GLANDULA SUPRARENALIS SUIS, MERCURIUS PRAECIPITATUS RUBER, SEPIA, ZINCUM METALLICUM, PALLADIUM METALLICUM, PICRICUM ACIDUM, SULPHUR, CARTILAGO SUIS, INTERVERTEBRAL DISC (SUIS), MEDULLA OSSIS SUISDeseret Biologicals, Inc.cec46d33-e106-481a-958d-b2aedabe18792017-04-12WarningsExact identifier
unii: ETJ7Z6XBU4
ReHydrationADENOSINUM CYCLOPHOSPHORICUM, COFFEA CRUDA, GLANDULA SUPRARENALIS SUIS, HYPOTHALAMUS (BOVINE), KALI PHOSPHORICUM, NATRUM MURIATICUM, SARSAPARILLA, SILICEA, TARAXACUM OFFICINALE, THYROIDINUM (BOVINE)Energetix Corp9883c502-9782-451e-9eec-c54d7b054f312017-01-31WarningsExact identifier
unii: ETJ7Z6XBU4
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: ETJ7Z6XBU4
ThyrotoxCHONDRUS CRISPUS, FUCUS VESICULOSUS, THYROIDINUM, BELLADONNA, CALCAREA CARBONICA, CONIUM MACULATUM, IODIUM, KALI CARBONICUM, PHOSPHORUS, PULSATILLA (VULGARIS), SILICEABioActive Nutritional, Inc.e229a260-13f3-4136-b325-9a8954f8a3272016-08-10WarningsExact identifier
unii: ETJ7Z6XBU4
TeethingARNICA MONTANA, TRIFOLIUM PRATENSE, CALCAREA CARBONICA, CALCAREA FLUORICA, CALCAREA PHOSPHORICA, CHAMOMILLA, KREOSOTUM, SILICEABioActive Nutritional, Inc.f39c9feb-f567-43a2-a026-2a581aeeed9d2016-07-27WarningsExact identifier
unii: ETJ7Z6XBU4
a30b6cba-3acf-46d5-92e6-74d3d787e3dafb79c214-e6ff-499a-9e23-a759bef9b7cb2013-07-22Boxed warning, Warnings, Adverse reactionsExact identifier
spl id: a30b6cba-3acf-46d5-92e6-74d3d787e3da
spl set id: fb79c214-e6ff-499a-9e23-a759bef9b7cb
364AD595-66FA-48C2-2EC6-3A9E6258FCE8A66ABF44-9AE9-4342-B69A-EBAA1F9B7D782006-11-27Boxed warning, Warnings, Adverse reactionsExact identifier
spl id: 364AD595-66FA-48C2-2EC6-3A9E6258FCE8
spl set id: A66ABF44-9AE9-4342-B69A-EBAA1F9B7D78
EB18D177-D3D2-1F6D-DA59-A7BF427FAF27A9987047-9C99-45A5-829B-AE8B189CBFD42006-02-06Boxed warning, Warnings, Adverse reactionsExact identifier
spl id: EB18D177-D3D2-1F6D-DA59-A7BF427FAF27
spl set id: A9987047-9C99-45A5-829B-AE8B189CBFD4

Reported adverse events (FAERS/openFDA)#

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