Metronidazole

Manufacturer: Cosette Pharmaceuticals, Inc. | Cosette Pharmaceuticals NC Laboratories, LLC
Effective date: 2023-11-29
Label type: HUMAN PRESCRIPTION DRUG LABEL
Version: 8
Source: full-release
Hydrated at: 2026-05-31 20:55:47

Label at a glance#

ProductMetronidazole

Active ingredientMETRONIDAZOLE

Label structure10 sections

Indications and uses

Metronidazole Topical Cream is indicated for topical application in the treatment of inflammatory papules and pustules of rosacea.

Dosage and administration

Apply and rub in a thin layer of Metronidazole Topical Cream twice daily, morning and evening, to entire affected areas after washing. Areas to be treated should be washed with a mild cleanser before application. Patients may use cosmetics after application of Metronidazole Topical Cream.

Storage and handling

Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature]. Protect from Freezing. Distributed by: Cosette Pharmaceuticals, Inc. South Plainfield, NJ 07080 8-0633CPLNC2 VC7649 Rev. 08/2022

Contacts and useful links#

PhoneLabel contact1-800-922-1038

PhoneFDA MedWatch1-800-FDA-1088

Websitewww.fda.gov

www.fda.gov/medwatch

Label contents#

Full prescribing information#

DESCRIPTION

DESCRIPTION SECTION

Metronidazole Topical Cream contains metronidazole, USP, at a concentration of 7.5 mg per gram (0.75%) in an emollient cream consisting of emulsifying wax, sorbitol solution, glycerin, isopropyl palmitate, benzyl alcohol, lactic acid and/or sodium hydroxide to adjust pH, and purified water. Metronidazole is a member of the imidazole class of antibacterial agents and is classified therapeutically as an antiprotozoal and antibacterial agent. Chemically, metronidazole is 2-methyl-5-nitro-1 H-imidazole-1-ethanol. The molecular formula is C ₆H ₉N ₃O ₃and molecular weight is 171.16. Metronidazole is represented by the following structural formula:

CLINICAL PHARMACOLOGY

CLINICAL PHARMACOLOGY SECTION

The mechanisms by which metronidazole acts in the treatment of rosacea are unknown, but appear to include an anti-inflammatory effect.

INDICATIONS AND USAGE

INDICATIONS & USAGE SECTION

Metronidazole Topical Cream is indicated for topical application in the treatment of inflammatory papules and pustules of rosacea.

CONTRAINDICATIONS

CONTRAINDICATIONS SECTION

Metronidazole Topical Cream is contraindicated in individuals with a history of hypersensitivity to metronidazole, or other ingredients of the formulation.

PRECAUTIONS

PRECAUTIONS SECTION

General:

GENERAL PRECAUTIONS SECTION

Topical metronidazole has been reported to cause tearing of the eyes. Therefore, contact with the eyes should be avoided. If a reaction suggesting local irritation occurs, patients should be directed to use the medication less frequently or discontinue use. Metronidazole is a nitroimidazole and should be used with care in patients with evidence of, or history of blood dyscrasia.

Information for patients:

GENERAL PRECAUTIONS SECTION

This medication is to be used as directed by the physician. It is for external use only. Avoid contact with the eyes.

Drug Interactions:

GENERAL PRECAUTIONS SECTION

Oral metronidazole has been reported to potentiate the anticoagulant effect of warfarin and coumarin anticoagulants, resulting in a prolongation of prothrombin time. The effect of topical metronidazole on prothrombin time is not known.

Carcinogenesis, mutagenesis, impairment of fertility :

GENERAL PRECAUTIONS SECTION

Metronidazole has shown evidence of carcinogenic activity in a number of studies involving chronic, oral administration in mice and rats but not in studies involving hamsters.

Metronidazole has shown evidence of mutagenic activity in several in vitrobacterial assay systems. In addition, a dose-response increase in the frequency of micronuclei was observed in mice after intraperitoneal injections and an increase in chromosome aberrations have been reported in patients with Crohn's disease who were treated with 200-1200 mg/day of metronidazole for 1 to 24 months. However, no excess chromosomal aberrations in circulating human lymphocytes have been observed in patients treated for 8 months.

Pregnancy:

GENERAL PRECAUTIONS SECTION

Teratogenic effects: Pregnancy category B

GENERAL PRECAUTIONS SECTION

There are no adequate and well-controlled studies with the use of Metronidazole Topical Cream in pregnant women. Metronidazole crosses the placental barrier and enters the fetal circulation rapidly. No fetotoxicity was observed after oral metronidazole in rats or mice. However, because animal reproduction studies are not always predictive of human response and since oral metronidazole has been shown to be a carcinogen in some rodents, this drug should be used during pregnancy only if clearly needed.

Nursing mothers:

GENERAL PRECAUTIONS SECTION

After oral administration, metronidazole is secreted in breast milk in concentrations similar to those found in the plasma. Even though blood levels are significantly lower with topically applied metronidazole than those achieved after oral administration of metronidazole, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Pediatric use:

GENERAL PRECAUTIONS SECTION

Safety and effectiveness in pediatric patients have not been established.

ADVERSE REACTIONS

ADVERSE REACTIONS SECTION

In controlled clinical trials, the total incidence of adverse reactions associated with the use of Metronidazole Topical Cream was approximately10%. Skin discomfort (burning and stinging) was the most frequently reported event followed by erythema, skin irritation, pruritus and worsening of rosacea. All individual events occurred in less than 3% of patients. The following additional adverse experiences have been reported with the topical use of metronidazole: dryness, transient redness, metallic taste, tingling or numbness of extremities and nausea.

To report SUSPECTED ADVERSE REACTIONS, contact Cosette Pharmaceuticals, Inc. at 1-800-922-1038 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

DOSAGE AND ADMINISTRATION

DOSAGE & ADMINISTRATION SECTION

Apply and rub in a thin layer of Metronidazole Topical Cream twice daily, morning and evening, to entire affected areas after washing.

Areas to be treated should be washed with a mild cleanser before application. Patients may use cosmetics after application of Metronidazole Topical Cream.

HOW SUPPLIED

HOW SUPPLIED SECTION

Metronidazole Topical Cream, 0.75% is supplied in a 45 g tube NDC0713-0633-37.

Storage conditions:

STORAGE AND HANDLING SECTION

Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature]. Protect from Freezing.

Distributed by:
Cosette Pharmaceuticals, Inc.
South Plainfield, NJ 07080

8-0633CPLNC2 VC7649
Rev. 08/2022

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 0713-0633-37

Metronidazole Topical Cream 0.75%

45 g

Rx only

FOR TOPICAL USE ONLY.

NOT FOR OPHTHALMIC USE.

Cosette Pharmaceuticals, Inc.

45 mg Carton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
311678	metroNIDAZOLE 0.75 % Topical Cream	PSN	8
311678	metronidazole 7.5 MG/ML Topical Cream	SCD	8
311678	metronidazole 0.75 % Topical Cream	SY	8

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
METRONIDAZOLE Pharmacologic Class Indexing	2	Indexing - Pharmacologic Class	20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
8ffb9b1d-3ed7-ba2e-677e-47d4d134fd55	Product name	5	20251024
7f6d14e0-4366-41bc-a4a9-b74c79a20e17	Product name	1	20250623
e6d321b0-0e5e-7da6-f043-92b6a91f00a1	Product name	5	20250515
e1aac33b-94ae-4ee9-905b-299f7263853b	Product name	3	20250124
16642716-d28a-4f90-8dcb-3921cd8c8109	Product name	4	20240516
0be8e4ae-4d57-49f3-b3a9-e4728b4e8d15	Product name	1	20240313
dea2eded-d1e7-46bb-9a3d-f8dc20de6277	Product name	1	20190408
a5070875-62bb-61e1-fd46-8f7054197a40	Product name	8	20180215
0add4de9-d152-3375-3390-1123dddc5e3d	Product name	1	20140508
33ca0fcc-1011-92dc-50a9-a383683eed1e	Product name	1	20140508
53f39d9f-cd3f-04e1-c668-d4580719d57d	Product name	1	20140508
a804000f-b74f-0b5d-d17b-aa767c286ddb	Product name	1	20140508
a91ea265-6e02-c08f-93c8-686d54180529	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0713-0633-37	Metronidazole	45 g in 1 TUBE	CREAM	45		8
0713-0633-37	Metronidazole	1 in 1 CARTON	CREAM	1		8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0713-0633	METRONIDAZOLE CREAM [COSETTE PHARMACEUTICALS, INC.]	8	Current NDC, Legacy NDC, 2 package rows	20231130_de4cb39f-cc6e-98fb-05e5-103f3aca2dad.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0713-0633-37	GM - Gram	0713-0633	20f23ae6-3959-44a0-b4f8-36c943e726af	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
Metronidazole	ACTIVE INGREDIENT	140QMO216E	2
Metronidazole	ACTIVE MOIETY	140QMO216E	2
Benzyl Alcohol	INACTIVE INGREDIENT	LKG8494WBH	2
Glycerin	INACTIVE INGREDIENT	PDC6A3C0OX	2
Isopropyl Palmitate	INACTIVE INGREDIENT	8CRQ2TH63M	2
Lactic Acid	INACTIVE INGREDIENT	33X04XA5AT	2
Sodium Hydroxide	INACTIVE INGREDIENT	55X04QC32I	2
Sorbitol	INACTIVE INGREDIENT	506T60A25R	2
Water	INACTIVE INGREDIENT	059QF0KO0R	2

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 8 matching rows.

Metronidazole
SORBITOL
GLYCERIN
ISOPROPYL PALMITATE
BENZYL ALCOHOL
LACTIC ACID, UNSPECIFIED FORM
SODIUM HYDROXIDE
WATER

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
0713-0633	0713-0633-37

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
SORBITOL	506T60A25R	IACT
GLYCERIN	PDC6A3C0OX	IACT
ISOPROPYL PALMITATE	8CRQ2TH63M	IACT
BENZYL ALCOHOL	LKG8494WBH	IACT
LACTIC ACID, UNSPECIFIED FORM	33X04XA5AT	IACT
SODIUM HYDROXIDE	55X04QC32I	IACT
WATER	059QF0KO0R	IACT
METRONIDAZOLE	140QMO216E	ACTIB

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 12 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
Sodium Hydroxide	SODIUM HYDROXIDE	55X04QC32I	CREAM / TOPICAL		69 mg	Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
Sodium Hydroxide	SODIUM HYDROXIDE	55X04QC32I	CREAM / TOPICAL		69 mg	Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	CREAM / TOPICAL		1720 mg	Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
Sorbitol	SORBITOL	506T60A25R	CREAM / TOPICAL	36.8 %w/w		Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
Sorbitol	SORBITOL	506T60A25R	CREAM / TOPICAL	36.8 %w/w		Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
Lactic Acid	LACTIC ACID	33X04XA5AT	CREAM / TOPICAL	1 %w/w		Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
Benzyl Alcohol	BENZYL ALCOHOL	LKG8494WBH	CREAM / TOPICAL		160 mg	Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
Benzyl Alcohol	BENZYL ALCOHOL	LKG8494WBH	CREAM / TOPICAL		160 mg	Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
Lactic Acid	LACTIC ACID	33X04XA5AT	CREAM / TOPICAL	1 %w/w		Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
Isopropyl Palmitate	ISOPROPYL PALMITATE	8CRQ2TH63M	CREAM / TOPICAL		112 mg	Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
Isopropyl Palmitate	ISOPROPYL PALMITATE	8CRQ2TH63M	CREAM / TOPICAL		112 mg	Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	CREAM / TOPICAL		1720 mg	Exact identifier — unii+route+dosage form 2 equally ranked IID candidates

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A077549-001	METRONIDAZOLE	METRONIDAZOLE	0.75%	CREAM / TOPICAL	AB		2007-12-19

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
A077549-001	AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A077549-001	METRONIDAZOLE	0.75%	CREAM / TOPICAL	AB	2007-12-19	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A077549-001	METRONIDAZOLE	0.75%	CREAM / TOPICAL	AB	2007-12-19	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077549-001	METRONIDAZOLE	0.75%	CREAM / TOPICAL	AB	2007-12-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077549-001	METRONIDAZOLE	0.75%	CREAM / TOPICAL	AB	2007-12-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077549-001	METRONIDAZOLE	0.75%	CREAM / TOPICAL	AB	2007-12-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077549-001	METRONIDAZOLE	0.75%	CREAM / TOPICAL	AB	2007-12-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077549-001	METRONIDAZOLE	0.75%	CREAM / TOPICAL	AB	2007-12-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077549-001	METRONIDAZOLE	0.75%	CREAM / TOPICAL	AB	2007-12-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077549-001	METRONIDAZOLE	0.75%	CREAM / TOPICAL	AB	2007-12-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077549-001	METRONIDAZOLE	0.75%	CREAM / TOPICAL	AB	2007-12-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077549-001	METRONIDAZOLE	0.75%	CREAM / TOPICAL	AB	2007-12-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077549-001	METRONIDAZOLE	0.75%	CREAM / TOPICAL	AB	2007-12-19	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077549-001	METRONIDAZOLE	0.75%	CREAM / TOPICAL	AB	2007-12-19	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077549-001	METRONIDAZOLE	0.75%	CREAM / TOPICAL	AB	2007-12-19	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077549-001	METRONIDAZOLE	0.75%	CREAM / TOPICAL	AB	2007-12-19	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077549-001	METRONIDAZOLE	0.75%	CREAM / TOPICAL	AB	2007-12-19	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077549-001	METRONIDAZOLE	0.75%	CREAM / TOPICAL	AB	2007-12-19	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077549-001	METRONIDAZOLE	0.75%	CREAM / TOPICAL	AB	2007-12-19	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077549-001	METRONIDAZOLE	0.75%	CREAM / TOPICAL	AB	2007-12-19	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077549-001	METRONIDAZOLE	0.75%	CREAM / TOPICAL	AB	2007-12-19	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077549-001	METRONIDAZOLE	0.75%	CREAM / TOPICAL	AB	2007-12-19	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A077549-001	METRONIDAZOLE	0.75%	CREAM / TOPICAL	AB	2007-12-19	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077549-001	METRONIDAZOLE	0.75%	CREAM / TOPICAL	AB	2007-12-19	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A077549-001	METRONIDAZOLE	0.75%	CREAM / TOPICAL	AB	2007-12-19	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A077549-001	METRONIDAZOLE	0.75%	CREAM / TOPICAL	AB	2007-12-19	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A077549-001	METRONIDAZOLE	0.75%	CREAM / TOPICAL	AB	2007-12-19	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A077549-001	METRONIDAZOLE	0.75%	CREAM / TOPICAL	AB	2007-12-19	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A077549-001	METRONIDAZOLE	0.75%	CREAM / TOPICAL	AB	2007-12-19	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A077549-001	METRONIDAZOLE	0.75%	CREAM / TOPICAL	AB	2007-12-19	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A077549-001	METRONIDAZOLE	0.75%	CREAM / TOPICAL	AB	2007-12-19	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A077549-001	METRONIDAZOLE	0.75%	CREAM / TOPICAL	AB	2007-12-19	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A077549-001	METRONIDAZOLE	0.75%	CREAM / TOPICAL	AB	2007-12-19	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A077549-001	METRONIDAZOLE	0.75%	CREAM / TOPICAL	AB	2007-12-19	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A077549-001	METRONIDAZOLE	0.75%	CREAM / TOPICAL	AB	2007-12-19	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A077549-001	METRONIDAZOLE	0.75%	CREAM / TOPICAL	AB	2007-12-19	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A077549-001	METRONIDAZOLE	0.75%	CREAM / TOPICAL	AB	2007-12-19	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A077549-001	METRONIDAZOLE	0.75%	CREAM / TOPICAL	AB	2007-12-19	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A077549-001	METRONIDAZOLE	0.75%	CREAM / TOPICAL	AB	2007-12-19	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A077549-001	METRONIDAZOLE	0.75%	CREAM / TOPICAL	AB	2007-12-19	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A077549-001	METRONIDAZOLE	0.75%	CREAM / TOPICAL	AB	2007-12-19	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A077549-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A077549-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077549-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077549-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077549-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077549-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077549-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077549-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077549-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077549-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077549-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077549-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077549-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077549-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077549-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077549-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077549-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077549-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077549-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077549-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077549-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A077549-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077549-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A077549-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A077549-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A077549-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A077549-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A077549-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A077549-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A077549-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A077549-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A077549-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A077549-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A077549-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A077549-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A077549-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A077549-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A077549-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A077549-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A077549-001	AB	1	`f41ea6bd6efb…`

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 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Metronidazole	METRONIDAZOLE	Cosette Pharmaceuticals, Inc.	de4cb39f-cc6e-98fb-05e5-103f3aca2dad	2023-11-29	Adverse reactions	Exact identifier ndc (package): 0713-0633-37 ndc (product): 0713-0633 ndc11 (package): 00713063337 spl id: 0b47088a-fa40-b41e-e063-6394a90acfb1 spl set id: de4cb39f-cc6e-98fb-05e5-103f3aca2dad

Reported adverse events (FAERS/openFDA)#

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