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 10 of 38 · 758 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Pneumo Drops 5018PNEUMO DROPSProfessional Complementary Health Formulasea6d0286-db1c-48c0-83fd-c18fa8f8629f2026-01-08WarningsExact identifier
unii: ETJ7Z6XBU4
Difficulty Breathing Drops 2171DIFFICULTY BREATHING DROPSProfessional Complementary Health Formulas30bab475-47dd-4261-b497-1f8edf9dd4112026-01-08WarningsExact identifier
unii: ETJ7Z6XBU4
RET Spleen/Pancreas 7002RET SPLEEN/PANCREASProfessional Complementary Health Formulasc6c82d50-0650-4cd9-85b9-c3cd422a35ce2026-01-08WarningsExact identifier
unii: ETJ7Z6XBU4
Vaccinosis Nosode 4004VACCINOSIS NOSODEProfessional Complementary Health Formulasdff675b3-6330-45d0-984c-526a8f44202b2026-01-08WarningsExact identifier
unii: ETJ7Z6XBU4
Sinusitis Drops 2060SINUSITIS DROPSProfessional Complementary Health Formulas00469764-e0ab-45cf-8e61-6bdc67d31e542026-01-08WarningsExact identifier
unii: ETJ7Z6XBU4
Large Ring Combination 9302LARGE RING COMBINATIONProfessional Complementary Health Formulascced8a69-7bc0-42ad-b80a-58fc603bf7652026-01-08WarningsExact identifier
unii: ETJ7Z6XBU4
Domestic Animals Nosode Combination 9407DOMESTIC ANIMALS NOSODE COMBINATIONProfessional Complementary Health Formulas222c28aa-e07b-4706-9fb5-585b190f1c5b2026-01-08WarningsExact identifier
unii: ETJ7Z6XBU4
METRONIDAZOLEMETRONIDAZOLEDirect_Rx90a5acb3-f8cc-1e82-e053-2995a90a4e972026-01-08Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 311681
unii: 140QMO216E
MetronidazoleMETRONIDAZOLEAmerican Health Packagingc90da73c-e48e-411a-bd75-0b107f1141cc2026-01-08Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 314106
rxcui: 311681
unii: 140QMO216E
Cataract Drops 2085CATARACT DROPSProfessional Complementary Health Formulas6040a096-ccdb-4e1e-a242-be29c3127f272026-01-08WarningsExact identifier
unii: ETJ7Z6XBU4
RET Thyroid/Adrenal 7011RET THYROID/ADRENALProfessional Complementary Health Formulaseb313eb9-4dfc-402e-92b3-14f09f4ba8692026-01-08WarningsExact identifier
unii: ETJ7Z6XBU4
Lymph Stim Liquescence 3016LYMPH STIM LIQUESCENCEProfessional Complementary Health Formulasd91939ea-e3dc-49b1-949a-6618a4c4ae0d2026-01-08WarningsExact identifier
unii: ETJ7Z6XBU4
Nitrogen Combination 9310NITROGEN COMBINATIONProfessional Complementary Health Formulas72a7c0f3-0a57-4aa8-8fe8-a3267b9acd532026-01-08WarningsExact identifier
unii: ETJ7Z6XBU4
Psorinum Miasm Drops 2054PSORINUM MIASM DROPSProfessional Complementary Health Formulasa34aadab-b634-461f-a0ff-58f42f6e08332026-01-08WarningsExact identifier
unii: ETJ7Z6XBU4
Pneumonia/Meningitis Nosode Combination 9414PNEUMONIA/MENINGITIS NOSODE COMBINATIONProfessional Complementary Health Formulas823de3e3-4d20-446c-988d-d7a70a747f9a2026-01-08WarningsExact identifier
unii: ETJ7Z6XBU4
Childhood Immunization Detox 6032CHILDHOOD IMMUNIZATION DETOXProfessional Complementary Health Formulas4d455d07-3197-44d6-99d6-488fcdb50f952026-01-08WarningsExact identifier
unii: ETJ7Z6XBU4
Allergy Nosode 4017ALLERGY NOSODEProfessional Complementary Health Formulasda9145a5-42e9-4dba-9d11-195848e628a42026-01-08WarningsExact identifier
unii: ETJ7Z6XBU4
Bone Stim Liquescence 3005BONE STIM LIQUESCENCEProfessional Complementary Health Formulas6e62dde0-adf2-4cdd-8340-abc6b10db3572026-01-08WarningsExact identifier
unii: ETJ7Z6XBU4
Connective Tissue Liquescence 3024CONNECTIVE TISSUE LIQUESCENCEProfessional Complementary Health Formulasb7dab801-0256-40d7-8f66-7a0e7e76c3532026-01-08WarningsExact identifier
unii: ETJ7Z6XBU4
Childhood Vaccination Nosode Combination 9409CHILDHOOD VACCINATION NOSODE COMBINATIONProfessional Complementary Health Formulasa7a262f1-fe38-4e6b-aefa-f9e8a914f38e2026-01-08WarningsExact identifier
unii: ETJ7Z6XBU4

Reported adverse events (FAERS/openFDA)#

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