NDC 0591-5540 - 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: 0591-5540
Package NDCs from labels: 0591-5540-50, 0591-5540-01, 0591-5540-25, 0591-5540-05, 0591-5540-10
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
Label	Manufacturer	Effective date	Type
Metronidazole - Physicians Total Care, Inc.	Physicians Total Care, Inc.	2013-07-22	HUMAN PRESCRIPTION DRUG LABEL
Metronidazole - Watson Labs	Watson Labs	2006-11-27	HUMAN PRESCRIPTION DRUG LABELING
Metronidazole - Watson Labs	Watson Labs	2006-02-06	HUMAN PRESCRIPTION DRUG LABELING

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
0591-5540-01	Metronidazole	100 in 1 BOTTLE	TABLET	100	3
0591-5540-05	Metronidazole	500 in 1 BOTTLE	TABLET	500	3
0591-5540-10	Metronidazole	1000 in 1 BOTTLE	TABLET	1000	3
0591-5540-25	Metronidazole	250 in 1 BOTTLE	TABLET	250	3
0591-5540-50	Metronidazole	50 in 1 BOTTLE	TABLET	50	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0591-5540	METRONIDAZOLE (METRONIDAZOLE) TABLET [WATSON LABS]	3	5 package rows	20061208_A66ABF44-9AE9-4342-B69A-EBAA1F9B7D78.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Metronidazole	ACTIVE INGREDIENT	140QMO216E	METRONIDAZOLE (METRONIDAZOLE) TABLET [WATSON LABS]	3
metronidazole	ACTIVE MOIETY	140QMO216E	METRONIDAZOLE (METRONIDAZOLE) TABLET [WATSON LABS]	3
Colloidial silicon dioxide	INACTIVE INGREDIENT		METRONIDAZOLE (METRONIDAZOLE) TABLET [WATSON LABS]	3
Crospovidone	INACTIVE INGREDIENT		METRONIDAZOLE (METRONIDAZOLE) TABLET [WATSON LABS]	3
Hydrogenated vegtable oil	INACTIVE INGREDIENT		METRONIDAZOLE (METRONIDAZOLE) TABLET [WATSON LABS]	3
Microcrystalline cellulose	INACTIVE INGREDIENT		METRONIDAZOLE (METRONIDAZOLE) TABLET [WATSON LABS]	3
METRONIDAZOLE	ACTIVE INGREDIENT	140QMO216E	METRONIDAZOLE TABLET [PHYSICIANS TOTAL CARE, INC.]	2
METRONIDAZOLE	ACTIVE MOIETY	140QMO216E	METRONIDAZOLE TABLET [PHYSICIANS TOTAL CARE, INC.]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	METRONIDAZOLE TABLET [PHYSICIANS TOTAL CARE, INC.]	2
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	METRONIDAZOLE TABLET [PHYSICIANS TOTAL CARE, INC.]	2
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	METRONIDAZOLE TABLET [PHYSICIANS TOTAL CARE, INC.]	2
Metronidazole	ACTIVE INGREDIENT	140QMO216E	METRONIDAZOLE (METRONIDAZOLE) TABLET [WATSON LABS]	1
Metronidazole	ACTIVE MOIETY	140QMO216E	METRONIDAZOLE (METRONIDAZOLE) TABLET [WATSON LABS]	1
Colloidial silicon dioxide	INACTIVE INGREDIENT		METRONIDAZOLE (METRONIDAZOLE) TABLET [WATSON LABS]	1
Crospovidone	INACTIVE INGREDIENT		METRONIDAZOLE (METRONIDAZOLE) TABLET [WATSON LABS]	1
Hydrogenated vegtable oil	INACTIVE INGREDIENT		METRONIDAZOLE (METRONIDAZOLE) TABLET [WATSON LABS]	1
Microcrystalline cellulose	INACTIVE INGREDIENT		METRONIDAZOLE (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 24 of 38 · 758 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ferrum Silicicum Urtica	FERRUM SILICICUM URTICA	Uriel Pharmacy Inc.	09829ac4-c074-7315-e063-6394a90adf59	2025-01-07	Warnings	Exact identifier unii: ETJ7Z6XBU4
MIMIBO PREMIUM TOOTH	SILICON DIOXIDE, TOCOPHEROL ACETATE, TETRASODIUM PYROPHOSPHATE	CONE MEDICAL Co., Ltd.	c0ff5df4-0b37-0b1b-e053-2a95a90a862c	2025-01-02	Warnings	Exact identifier unii: ETJ7Z6XBU4
MIMIBO PREMIUM TOOTH	SILICON DIOXIDE, TOCOPHEROL ACETATE, TETRASODIUM PYROPHOSPHATE	CONE MEDICAL Co., Ltd.	c101881a-5a12-2e04-e053-2a95a90a3f57	2025-01-02	Warnings	Exact identifier unii: ETJ7Z6XBU4
NativeRemedies Acid Free-Flux	CALC PHOS 9X, CARBO VEG 6C, MAG CARB 6C, NAT PHOS 9X, SILICEA 9X	Silver Star Brands	d5012b1f-861e-40b8-e053-2a95a90a4fe2	2025-01-01	Warnings	Exact identifier unii: ETJ7Z6XBU4
Mucus Clear Allergy Relief	ALLIU CEPA, CALC PHOS, EUPHRASIA, IGNATIA, KALI MUR, NAT MUR, NUX VOM, PULSATILLA, SILICA	Silver Star Brands	f49bdcc1-1939-6dc2-e053-2995a90a0a3b	2025-01-01	Warnings	Exact identifier unii: ETJ7Z6XBU4
NativeRemedies Gout-Gone	ANTIMON CRUD, BENZOICUM AC, LEDUM, NUX VOM, QUERCUS, RHODODENDRON, SILICEA	Silver Star Brands	f66b42f0-8f5f-1aca-e053-2a95a90ae396	2025-01-01	Warnings	Exact identifier unii: ETJ7Z6XBU4
NeuropathEase	AGARICUS MUSC, ARSENICUM ALB, HYPERICUM, PHOS, SILICEA	Silver Star Brands	7809e54a-018d-9cf6-e053-2a91aa0aedfe	2025-01-01	Warnings	Exact identifier unii: ETJ7Z6XBU4
AllergiClear-M	ADRENALINUM, CALCAREA FLUORICA, CALCAREA PHOSPHORICA, EUPHRASIA OFFICINALIS, HISTAMINUM HYDROCHLORICUM, KALI MURIATICUM, NATRUM MURIATICUM, SILICEA	Silver Star Brands	9d36096b-022f-5cfa-e053-2995a90a381f	2025-01-01	Warnings	Exact identifier unii: ETJ7Z6XBU4
LIKMEZ	METRONIDAZOLE ORAL	Kesin Pharma Corporation	23927a8b-1641-4104-aa85-d7b7bf4ebb9d	2024-12-30	Boxed warning, Warnings, Adverse reactions	Exact identifier unii: 140QMO216E
Metronidazole	METRONIDAZOLE	NuCare Pharmaceuticals,Inc.	a860b097-7447-a3b7-e053-2995a90a4bfd	2024-12-26	Boxed warning, Warnings, Adverse reactions	Exact identifier rxcui: 314106 unii: 140QMO216E
Trace Mineral Cord	ARGENTUM METALLICUM, AURUM METALLICUM, BORON CITRATE, CALCAREA FLUORICA, CALCAREA PHOSPHORICA, CALCAREA SULPHURICA, CHROMIUM SULPHURICUM, COBALT GLUCONATE, CUPRUM SULPHURICUM, FERRUM PHOSPHORICUM, GERMANIUM SESQUIOXIDE, IODIUM, KALI BROMATUM, KALI MURIATICUM, KALI PHOSPHORICUM, KALI SULPHURICUM, LITHIUM CARBONICUM, MAGNESIA PHOSPHORICA, MANGANUM MURIATICUM, NATRUM MURIATICUM, NATRUM PHOSPHORICUM, NATRUM SULPHURICUM, SELENIUM METALLICUM, SILICEA, SODIUM MOLYBDATE, STRONTIUM CARBONICUM, VANADIUM METALLICUM,	Energique, Inc.	902dd68d-5ce1-481e-8938-6487dcc68dfc	2024-12-19	Warnings	Exact identifier unii: ETJ7Z6XBU4
Metronidazole	METRONIDAZOLE	Quality Care Products LLC	0d8125d6-173f-4498-85a9-a1323c7a0e42	2024-12-17	Boxed warning, Warnings, Adverse reactions	Exact identifier rxcui: 311681 unii: 140QMO216E
Metronidazole	METRONIDAZOLE	Viona Pharmaceuticals Inc	93299502-6cb0-48a4-8190-50fef74bdbee	2024-12-06	Adverse reactions	Exact identifier unii: 140QMO216E
Geovita	CEREBRUM, CUPRUM MET, FERRUM MET, FORMICUM ACIDUM, SILICEA	RUBIMED AG	0fcb5c06-d414-456c-a0ef-28e14018a781	2024-11-29	Warnings	Exact identifier unii: ETJ7Z6XBU4
Para-Si	JUGLANS REG, ABROTANUM, AESCULUS HIPP, ALLIUM SAT, ARSENICUM ALB, ARTEMISIA, BAPTISIA, CINA, CUPRUM MET, FILIX MAS, GRANATUM, IPECAC, LACHESIS, LYCOPODIUM, MERC VIV, NAPHTHALINUM, NAT MUR, NUX VOM, PULSATILLA, RATANHIA, RUTA, SABADILLA, SANTONINUM, SILICEA, SPIGELIA ANTH, TEREBINTHINA, TEUCRIUM MAR, THYMOLUM, ZINGIBER	Newton Laboratories, Inc.	27d41602-9dcb-eaa8-e063-6394a90a7cfa	2024-11-26	Warnings	Exact identifier unii: ETJ7Z6XBU4
Para-Si	JUGLANS REG, ABROTANUM, AESCULUS HIPP, ALLIUM SAT, ARSENICUM ALB, ARTEMISIA, BAPTISIA, CINA, CUPRUM MET, FILIX MAS, GRANATUM, IPECAC, LACHEIS, LYCOPODIUM, MERC VIV, NAPHTHALINUM, NAT MUR, NUX VOM, PULSATILLA, RATANHIA, RUTA, SABADILLA, SANTONINUM, SILICEA, SPIGELIA ANTH, TEREBINTHINA, TEUCRIUM MAR, THYMOLUM, ZINGIBER	Newton Laboratories, Inc.	27d4ddaf-9c07-a7fc-e063-6394a90adc0b	2024-11-26	Warnings	Exact identifier unii: ETJ7Z6XBU4
Para-Si	JUGLANS REG, ABROTANUM, AESCULUS HIPP, ALLIUM SAT, ARSENICUM ALB, ARTEMISIA, BAPTISIA, CINA, CUPRUM MET, FILIX MAS, GRANATUM, IPECAC, LACHESIS, LYCOPODIUM, MERC VIV, NAPHTHALINUM, NAT MUR NUX VOM, PULSATILLA, RATANHIA, RUTA, SABADILLA, SANTONINUM, SILICEA, SPIGELIA ANTH, TEREBINTHINA, TEUCRIUM MAR, THYMOLUM, ZINGIBER	Newton Laboratories, Inc.	27d5997b-1cae-41c2-e063-6394a90ac74a	2024-11-26	Warnings	Exact identifier unii: ETJ7Z6XBU4
Hempvana Ultra Pain Relief Homeopathic Cream Platinum - Nerve Relief	ARNICA MONTANA, ACONITUM NAPELLUS, HYPERICUM PERFORATUM, LEDUM PALUSTRE, MAGNESIA PHOSPHORICA, SECALE CORNUTUM, SILICEA	TELEBRANDS CORP	2787f88c-752e-cbaa-e063-6394a90a732c	2024-11-21	Warnings	Exact identifier unii: ETJ7Z6XBU4
Hempvana Ultra Pain Relief - Nerve Relief	ARNICA MONTANA, ACONITUM NAPELLUS, HYPERICUM PERFORATUM, LEDUM PALUSTRE, MAGNESIA PHOSPHORICA, SECALE CORNUTUM, SILICEA	TELEBRANDS CORP	f93a1ed0-5046-0355-e053-6294a90a6a90	2024-11-20	Warnings	Exact identifier unii: ETJ7Z6XBU4
ReHydration	ADENOSINUM CYCLOPHOSPHORICUM, COFFEA CRUDA, GLANDULA SUPRARENALIS SUIS, HYPOTHALAMUS, KALI PHOS, NAT MUR, SARSAPARILLA, SILICEA, TARAXACUM, THYROIDINUM	Energetix Corporation	37063a49-6b45-4167-875d-49c9dac3f79b	2024-11-20	Warnings	Exact identifier unii: ETJ7Z6XBU4

Reported adverse events (FAERS/openFDA)#

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