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 15 of 38 · 758 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Bambusa PulsatillaBAMBUSA PULSATILLAUriel Pharmacy Inc.0776c3be-088d-422c-9c12-08fcaae823e12025-11-26WarningsExact identifier
unii: ETJ7Z6XBU4
Thyroid-AdrenalADRENALINUM, THYROIDINUM, ALOE, CALC. CARB., CHELIDONIUM MAJUS, CONIUM, GRAPHITES, IODIUM, LACHESIS, LYCOPODIUM, LYCOPUS VIRGINICUS, PHYTOLACCA, RHUS TOXICODENDRON, SILICEA, SPONGIA, ECHINACEANewton Laboratories, Inc.b597504a-c667-225c-e053-2a95a90ac7042025-11-25WarningsExact identifier
unii: ETJ7Z6XBU4
DOCTRUST ONE S ToothSODIUM FLUORIDE, DENTAL TYPE SILICA, POTASSIUM NIRATEDONG IL PHARMS CO.,LTD4476923a-48f1-9f72-e063-6394a90a07082025-11-25WarningsExact identifier
unii: ETJ7Z6XBU4
DOCTRUST K ToothSILICON DIOXIDE, SODIUM MONOFLUOROPHOSPHATEDONG IL PHARMS CO.,LTD44768dd1-b132-c33b-e063-6294a90accd42025-11-25WarningsExact identifier
unii: ETJ7Z6XBU4
Gout Pain ManagementARNICA MONTANA, URTICA URENS, SILICON DIOXIDE, AND THUJA OCCIDENTALIS LEAFForces of Nature9276fe9c-d9a2-4cef-986c-5d7d39f2d6a12025-11-25WarningsExact identifier
unii: ETJ7Z6XBU4
Natural Eyes Floaters ReliefCHELIDONIUM, EUPHRASIA, KALI SULPH, NATRUM MURIATICUM, PHOSPHORUS, PHYSOSTIGMA, SEPIA, SILICEATRP Company445dc831-195e-4b25-e063-6294a90a6efd2025-11-24WarningsExact identifier
unii: ETJ7Z6XBU4
Lymph HPACONITUM NAPELLUS, ARSENICUM ALBUM, BAPTISIA TINCTORIA, BELLADONNA, BRYONIA, CAUSTICUM, ECHINACEA, EUPATORIUM PERFOLIATUM, FERRUM PHOSPHORICUM, GELSEMIUM SEMPERVIRENS, HYDRASTIS CANADENSIS, HYPERICUM PERFORATUM, KALI CARBONICUM, LACHESIS MUTUS, LOBELIA INFLATA, LOMATIUM DISSECTUM, LUNG, NATRUM SULPHURICUM, PHOSPHORUS, PHYTOLACCA DECANDRA, PULSATILLA, PYROGENIUM, RHUS TOX, SILICEA, SULPHUR, SYMPHYTUM OFFICINALEEnergique, Inc.17aa9d9c-3d32-4963-91db-d1e96717e7ad2025-11-24WarningsExact identifier
unii: ETJ7Z6XBU4
MetronidazoleMETRONIDAZOLECivica, Inc.902ab25b-d493-495a-884e-96b080e9f72d2025-11-21Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 140QMO216E
CONSTIPATIONMAGNESIA CARBONICA, MAGNESIA MURIATICA, AESCULUS HIPPOCASTANUM, ALUMEN, ALUMINA, BRYONIA ALBA, NUX VOMICA, SILICEANatural Creations, Inc.d2e24f5a-747b-4d62-bbdf-16c0e43becdb2025-11-21WarningsExact identifier
unii: ETJ7Z6XBU4
Pneumo SarcodeTEUCRIUM SCORODONIA, ARSENICUM IODATUM, LUNG (BOVINE), CALCAREA PHOSPHORICA, STANNUM METALLICUM, CARBO VEGETABILIS, PHELLANDRIUM AQUATICUM, SILICEA, SULPHURNutritional Specialties, Inc.c3a7cf75-723e-4fb9-8ff8-ae8f73a0900d2025-11-20WarningsExact identifier
unii: ETJ7Z6XBU4
GelusilALUMINA, MAGNESIA, SIMETHICONEWellSpring Pharmaceutical Corporation92fbeec1-1562-40f3-9734-41f133d494f92025-11-20WarningsExact identifier
unii: ETJ7Z6XBU4
ColdBAPTISIA TINCTORIA, ECHINACEA ANGUSTIFOLIA, EUPATORIUM PERFOLIATUM, LOMATIUM DISSECTUM, PUERARIA LOBATA, TRIFOLIUM PRATENSE, PHYTOLACCA DECANDRA, ALLIUM CEPA, ARSENICUM IODATUM, BARYTA CARBONICA, BROMIUM, CALCAREA CARBONICA, KALI MURIATICUM, LACHESIS MUTUS, MERCURIUS SOLUBILIS, SILICEANatural Creations, Incc45d1d8f-24be-4c13-8c4b-3889624214152025-11-20WarningsExact identifier
unii: ETJ7Z6XBU4
MetronidazoleMETRONIDAZOLEHospira, Inc.49360d6f-c8b3-420e-af75-154cf7b052552025-11-19Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 140QMO216E
Endometrium ArgentumENDOMETRIUM ARGENTUMUriel Pharmacy Inc.5590d577-3a98-49b8-bb12-ddd7f5cfd0802025-11-19WarningsExact identifier
unii: ETJ7Z6XBU4
Dizziness HPCALCAREA CARBONICA, CHENOPODIUM ANTHELMINTICUM, COCCULUS INDICUS, CONIUM MACULATUM, NUX VOMICA, PHOSPHORUS, PULSATILLA (PRATENSIS), SILICEA, TABACUM,Energique, Inc.0bf53ecc-c2ad-40b5-b921-7c10a1b006262025-11-19WarningsExact identifier
unii: ETJ7Z6XBU4
Formica Stibium comp.FORMICA STIBIUM COMP.Uriel Pharmacy Inc.439073f2-1dee-4b4e-a65e-74aee1c73c2b2025-11-17WarningsExact identifier
unii: ETJ7Z6XBU4
Lavender Quartz Ear OilLAVENDER QUARTZ EAR OILUriel Pharmacy Inc.b1a8d75c-77a9-40a7-8dd8-9c32cac31d2c2025-11-17WarningsExact identifier
unii: ETJ7Z6XBU4
Polygonatum CepaPOLYGONATUM CEPAUriel Pharmacy Inc.6ba0ac36-16cc-49bd-b37f-90cf18acbd5a2025-11-17WarningsExact identifier
unii: ETJ7Z6XBU4
Bambusa Viscum StannumBAMBUSA VISCUM STANNUMUriel Pharmacy Inc.7b2a95d0-6f51-4a6b-b05f-fe7d13d83b892025-11-14WarningsExact identifier
unii: ETJ7Z6XBU4
BELLA HPATROPA BELLADONNA, CONIUM MACULATUM FLOWERING TOP, SOLANUM DULCAMARA TOP, CALCIUM SULFIDE, POTASSIUM DICHROMATE, MERCURIUS SOLUBILIS, ANEMONE PULSATILLA, SILICON DIOXIDE, MATRICARIA RECUTITA.Natural Creations, Inc.8e46906b-9c22-4a8e-ae4e-f1fbfb3d35b12025-11-13WarningsExact identifier
unii: ETJ7Z6XBU4

Reported adverse events (FAERS/openFDA)#

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