FDA.reportPublic FDA data

NDC 0591-5552-01 - 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
Requested NDC
0591-5552-01
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 22 of 37 · 732 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
D-48PICRIC ACID, BRYONIA ALBA ROOT, CINCHONA OFFICINALIS BARK, SOLANUM DULCAMARA WHOLE, POTASSIUM CARBONATE, PHOSPHORUS, SEPIA OFFICINALIS JUICE, SILICON DIOXIDE, LYCOPODIUM CLAVATUM SPORE, AND FERROSOFERRIC PHOSPHATEDNA Labs, Inc.1d55827f-0ea2-4eda-ae43-7c0723e5708e2025-01-13WarningsExact identifier
unii: ETJ7Z6XBU4
D-132SILICON DIOXIDEDNA Labs, Inc.3d8e499d-ebe2-45b9-b078-256268c42d4b2025-01-13WarningsExact identifier
unii: ETJ7Z6XBU4
D-112LACHESIS MUTA VENOM, SILICON DIOXIDE, SODIUM CHLORIDE, RANUNCULUS BULBOSUS, ACONITUM NAPELLUS, ACTIVATED CHARCOAL, NITROGLYCERIN, OYSTER SHELL CALCIUM CARBONATE, CRUDE, ANEMONE PRATENSIS, PLANTAGO MAJOR, ARSENIC TRIOXIDE, AND MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATEDNA Labs, Inc.8d517ef2-3a1e-4393-9452-a4cd0f0a3bca2025-01-13WarningsExact identifier
unii: ETJ7Z6XBU4
D-117ATROPA BELLADONNA AND SILICON DIOXIDEDNA Labs, Inc.8bcce284-f8f3-4d62-a13e-b93c2c655a702025-01-13WarningsExact identifier
unii: ETJ7Z6XBU4
D-109ATROPA BELLADONNA, VIROLA SEBIFERA RESIN, SILICON DIOXIDE, CALCIUM FLUORIDE, SODIUM BORATE, GOLD, BAPTISIA TINCTORIA ROOT, MERCURIC CYANIDE, CALOMEL, AND CORNUS RUGOSA WHOLEDNA Labs, Inc.7758341d-e0be-487a-ba47-8847551231e12025-01-13WarningsExact identifier
unii: ETJ7Z6XBU4
D-137APIS MELLIFERA, ARSENIC TRIOXIDE, BAPTISIA TINCTORIA, ATROPA BELLADONNA, ECHINACEA PURPUREA, EUPATORIUM PERFOLIATUM WHOLE, GELSEMIUM SEMPERVIRENS WHOLE, CALCIUM SULFIDE, RANCID BEEF, SULFUR, SILICON DIOXIDE, AND THUJA OCCIDENTALIS LEAFY TWIGDNA Labs, Inc.240d03c0-957b-48e4-9bab-43f9e6b8fb422025-01-13WarningsExact identifier
unii: ETJ7Z6XBU4
D-133CALCIUM FLUORIDE, SILICON DIOXIDE, TRIBASIC CALCIUM PHOSPHATE, CALCIUM SULFATE ANHYDROUS, FERROSOFERRIC PHOSPHATE, POTASSIUM CHLORIDE, DIBASIC POTASSIUM PHOSPHATE, POTASSIUM SULFATE, MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE, SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE, SODIUM CHLORIDE, AND SODIUM SULFATEDNA Labs, Inc.a250b7e9-7fd2-4cb0-82f3-baa089d174412025-01-13WarningsExact identifier
unii: ETJ7Z6XBU4
Aurum HypericumAURUM HYPERICUMUriel Pharmacy Incbe0da1f0-06a1-11df-8a39-0800200c9a662025-01-10WarningsExact identifier
unii: ETJ7Z6XBU4
AM-9SPIGELIA ANTHELMIA, SILICON DIOXIDE, AND CORALLIUM RUBRUM WHOLEDNA Labs, Inc.d7a00f0b-de4c-4bff-b8e0-86a82bed8bb92025-01-09WarningsExact identifier
unii: ETJ7Z6XBU4
N-8SILICON DIOXIDE, ATROPA BELLADONNA, CITRULLUS COLOCYNTHIS FRUIT PULP, BLACK COHOSH, ANEMONE PULSATILLA, SEPIA OFFICINALIS JUICE, PALLADIUM, APIS MELLIFERA, AND BOS TAURUS OVARYDNA Labs, Inc.c25cdcb5-9469-48bb-b216-0a9d8d644e122025-01-09WarningsExact identifier
unii: ETJ7Z6XBU4
N-23ANEMONE PULSATILLA, PHOSPHORUS, SILICON DIOXIDE, NITRIC ACID, ARSENIC TRIOXIDE, TOXICODENDRON PUBESCENS WHOLE, AND BOS TAURUS HYPOTHALAMUSDNA Labs, Inc.b6365b49-06fb-4692-96f7-a5097b70bc912025-01-09WarningsExact identifier
unii: ETJ7Z6XBU4
N-16MGO ENERGIZERDNA Labs, Inc.8292b900-86c1-47ea-81da-b587439c76642025-01-09WarningsExact identifier
unii: ETJ7Z6XBU4
N-21CALCIUM FLUORIDE, SILICON DIOXIDE, EUPHRASIA STRICTA, RUTA GRAVEOLENS WHOLE, GELSEMIUM SEMPERVIRENS WHOLE, PHYSOSTIGMA VENENOSUM WHOLE, ANEMONE PULSATILLA, SODIUM CHLORIDE, AND SUS SCROFA EYEDNA Labs, Inc.89967941-c4ee-4598-a66d-8a93d69a4d652025-01-09WarningsExact identifier
unii: ETJ7Z6XBU4
N-18OYSTER SHELL CALCIUM CARBONATE, CRUDE, SEPIA OFFICINALIS JUICE, SILICON DIOXIDE, NITRIC ACID, AND SUS SCROFA PINEAL GLANDDNA Labs, Inc.3565c5d5-dc68-4f3f-99ec-30f8952393e02025-01-09WarningsExact identifier
unii: ETJ7Z6XBU4
N-24METABOLINDNA Labs, Inc.559fca2b-1093-4bdf-be70-c453f87002c32025-01-09WarningsExact identifier
unii: ETJ7Z6XBU4
NO-WEAK-NAILSGRAPHITE, THUJA OCCIDENTALIS LEAFY TWIG, AND SILICON DIOXIDEMiers Laboratories9158cd3f-4c27-40e9-bc07-fd560375c3a12025-01-09WarningsExact identifier
unii: ETJ7Z6XBU4
Ferrum Silicicum UrticaFERRUM SILICICUM URTICAUriel Pharmacy Inc.09829ac4-c074-7315-e063-6394a90adf592025-01-07WarningsExact identifier
unii: ETJ7Z6XBU4
MIMIBO PREMIUM TOOTHSILICON DIOXIDE, TOCOPHEROL ACETATE, TETRASODIUM PYROPHOSPHATECONE MEDICAL Co., Ltd.c0ff5df4-0b37-0b1b-e053-2a95a90a862c2025-01-02WarningsExact identifier
unii: ETJ7Z6XBU4
MIMIBO PREMIUM TOOTHSILICON DIOXIDE, TOCOPHEROL ACETATE, TETRASODIUM PYROPHOSPHATECONE MEDICAL Co., Ltd.c101881a-5a12-2e04-e053-2a95a90a3f572025-01-02WarningsExact identifier
unii: ETJ7Z6XBU4
NativeRemedies Acid Free-FluxCALC PHOS 9X, CARBO VEG 6C, MAG CARB 6C, NAT PHOS 9X, SILICEA 9XSilver Star Brandsd5012b1f-861e-40b8-e053-2a95a90a4fe22025-01-01WarningsExact identifier
unii: ETJ7Z6XBU4

Reported adverse events (FAERS/openFDA)#

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