METRONIDAZOLE GEL USP 0.75%

Manufacturer: Fougera Pharmaceuticals Inc.
Effective date: 2020-03-12
Label type: HUMAN PRESCRIPTION DRUG LABEL
Version: 8
Source: legacy-cache
Hydrated at: 2026-08-01 23:39:14

Label at a glance#

ProductMetronidazole

Active ingredientMETRONIDAZOLE

Label structure11 sections

Indications and uses

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

Dosage and administration

Apply and rub in a thin film of metronidazole gel twice daily, morning and evening, to entire affected areas after washing. Areas to be treated should be cleansed before application of metronidazole gel. Patients may use cosmetics after application of metronidazole gel.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

FOR TOPICAL USE ONLY.
NOT FOR OPHTHALMIC USE.
Rx only

INDICATIONS AND USAGE

INDICATIONS & USAGE SECTION

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

DOSAGE AND ADMINISTRATION

DOSAGE & ADMINISTRATION SECTION

CONTRAINDICATIONS

CONTRAINDICATIONS SECTION

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

PRECAUTIONS:

PRECAUTIONS SECTION

GENERAL PRECAUTIONS SECTION

General: Metronidazole gel 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 SECTION

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

DRUG INTERACTIONS SECTION

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

Carcinogenesis, mutagenesis, impairment of fertility:

CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY 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 vitro bacterial 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: Teratogenic effects: Pregnancy category B:

TERATOGENIC EFFECTS SECTION

There has been no experience to date with the use of metronidazole gel in pregnant patients. 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 SECTION

Nursing mothers: After oral administration, metronidazole is secreted in breast milk in concentrations similar to those found in the plasma. Even though metronidazole gel blood levels are significantly lower than those achieved after oral 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 SECTION

Pediatric use: Safety and effectiveness in pediatric patients have not been established.

ADVERSE REACTIONS

ADVERSE REACTIONS SECTION

The following adverse experiences have been reported with the topical use of metronidazole: burning, skin irritation, dryness, transient redness, metallic taste, tingling or numbness of extremities and nausea.

DESCRIPTION

DESCRIPTION SECTION

Metronidazole Gel USP 0.75% contains metronidazole, USP, at a concentration of 7.5 mg per gram (0.75%) in a gel consisting of purified water, methylparaben, propylparaben, propylene glycol, carbomer 940, sodium hydroxide, and edetate disodium. Metronidazole is classified therapeutically as an antiprotozoal and anti-bacterial agent. Chemically, metronidazole is named 2-methyl-5-nitroimidazole-1-ethanol and has the following structure:

CLINICAL PHARMACOLOGY

CLINICAL PHARMACOLOGY SECTION

Bioavailability studies on the topical administration of 1 gram of metronidazole gel (7.5 mg of metronidazole) to the face of 10 rosacea patients showed a maximum serum concentration of 66 nanograms per milliliter in one patient. This concentration is approximately 100 times less than concentrations afforded by a single 250 mg oral tablet. The serum metronidazole concentrations were below the detectable limits of the assay at the majority of time points in all patients. Three of the patients had no detectable serum concentrations of metronidazole at any time point. The mean dose of gel applied during clinical studies was 600 mg which represents 4.5 mg of metronidazole per application. Therefore, under normal usage levels, the formulation affords minimal serum concentrations of metronidazole. The mechanisms by which metronidazole gel acts in the treatment of rosacea are unknown, but appear to include an anti-inflammatory effect.

HOW SUPPLIED

HOW SUPPLIED SECTION

Metronidazole Gel USP 0.75% is supplied as follows:

45 gram tube NDC 0168-0275-45

Store at 20° to 25°C (68° to 77°F)
[see USP Controlled Room Temperature].

E. FOUGERA & CO.
A division of Fougera Pharmaceuticals Inc.
Melville, New York 11747

I2275D
R07/13
#87

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 45 GRAM TUBE

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 0168-0275-45

Fougera^®

METRONIDAZOLE
GEL USP 0.75%

Rx only

FOR TOPICAL USE ONLY.
NOT FOR OPHTHALMIC USE.
WARNING: KEEP OUT OF
REACH OF CHILDREN.

NET WT 45 grams

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 45 GRAM CARTON

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 0168-0275-45

Fougera^®

METRONIDAZOLE
GEL USP 0.75%

Rx only

FOR TOPICAL USE ONLY.
NOT FOR OPHTHALMIC USE.

NET WT 45 grams

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0168-0275-45	GM - Gram	0168-0275	5199dd79-6f07-4f4f-8290-05d6b5524fbb	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
METRONIDAZOLE	ACTIVE INGREDIENT	140QMO216E	6
METRONIDAZOLE	ACTIVE MOIETY	140QMO216E	6
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)	INACTIVE INGREDIENT	4Q93RCW27E	6
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	6
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	6
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	6
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	6
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	6
WATER	INACTIVE INGREDIENT	059QF0KO0R	6

Products#

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

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

Metronidazole
WATER
METHYLPARABEN
PROPYLPARABEN
PROPYLENE GLYCOL
SODIUM HYDROXIDE
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)
EDETATE DISODIUM

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
0168-0275	0168-0275-45

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
METRONIDAZOLE	140QMO216E	ACTIB
WATER	059QF0KO0R	IACT
METHYLPARABEN	A2I8C7HI9T	IACT
PROPYLPARABEN	Z8IX2SC1OH	IACT
PROPYLENE GLYCOL	6DC9Q167V3	IACT
SODIUM HYDROXIDE	55X04QC32I	IACT
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)	4Q93RCW27E	IACT
EDETATE DISODIUM	7FLD91C86K	IACT

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 9 · 488 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	INJECTION, SOLUTION / INTRA-ARTICULAR	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	SOLUTION / RECTAL	0.02 %w/v		Exact identifier — unii candidate 68 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	5.4 mg		Exact identifier — unii candidate 174 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	INJECTION, POWDER, FOR SOLUTION / PARENTERAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	AEROSOL, FOAM / TOPICAL		1800 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	LIQUID / ORAL	0.5 mg/1ml		Exact identifier — unii candidate 77 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SOLUTION / OPHTHALMIC	1 %w/v		Exact identifier — unii candidate 81 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SYRUP / ORAL		81 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SUSPENSION / OPHTHALMIC	0.6 %w/v		Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	INJECTION / INTRAVENOUS		16624 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	CREAM, AUGMENTED / TOPICAL		2 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	TAMPON / VAGINAL	62.1 mg		Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SUSPENSION, EXTENDED RELEASE / ORAL		1000 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	SHAMPOO / TOPICAL	0.03 %w/w		Exact identifier — unii candidate 68 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	INJECTION, SOLUTION / EPIDURAL		30 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	TABLET, COATED / ORAL	0.21 mg		Exact identifier — unii candidate 77 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	POWDER, FOR SOLUTION / ORAL		13 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	GEL / TOPICAL		70 mg	Exact identifier — unii candidate 174 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	CAPSULE / ORAL		7 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)	CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)	4Q93RCW27E	GEL / TOPICAL		85 mg	Exact identifier — unii candidate 9 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS	63.4 %w/v		Exact identifier — unii candidate 81 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	INJECTION, SOLUTION / SUBCUTANEOUS		2 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SPRAY / NASAL		1 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	TABLET, ORALLY DISINTEGRATING / ORAL		1 mg	Exact identifier — unii candidate 174 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	INJECTION, SUSPENSION / INTRASYNOVIAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	DROPS / AURICULAR (OTIC)	NA		Exact identifier — unii candidate 68 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	PASTE, DENTIFRICE / DENTAL	0.05 %w/w		Exact identifier — unii candidate 79 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	DROPS / OPHTHALMIC	0.01 %w/w		Exact identifier — unii candidate 79 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	INJECTION, SOLUTION / INTRAMUSCULAR		5 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	GEL, METERED / TOPICAL		1225 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	INJECTION, SUSPENSION / SOFT TISSUE		1 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SYRUP / ORAL		40 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	SUSPENSION, EXTENDED RELEASE / INTRASYNOVIAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	INJECTION / SOFT TISSUE	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	CREAM / VAGINAL		3 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	EMULSION / TOPICAL	0.06 %w/w		Exact identifier — unii candidate 68 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	SOLUTION / AURICULAR (OTIC)	0.8 %w/w		Exact identifier — unii candidate 174 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	TABLET, FILM COATED / ORAL	4 mg		Exact identifier — unii candidate 77 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	INJECTION, POWDER, FOR SUSPENSION / INTRAVENOUS	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	FILM, SOLUBLE / BUCCAL		5 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	TABLET, EXTENDED RELEASE / ORAL	9 mg		Exact identifier — unii candidate 81 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	SPRAY, METERED / NASAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	DROPS / AURICULAR (OTIC)	0.01 %w/w		Exact identifier — unii candidate 79 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	OINTMENT / DENTAL	NA		Exact identifier — unii candidate 81 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	SUSPENSION/ DROPS / OPHTHALMIC	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	INJECTION / INTRALESIONAL	0.02 %w/v		Exact identifier — unii candidate 68 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	SOLUTION/ DROPS / TOPICAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	AEROSOL, METERED / RESPIRATORY (INHALATION)	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	GEL, METERED / TRANSDERMAL		350 mg	Exact identifier — unii candidate 174 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	DROPS / AURICULAR (OTIC)	0.05 %w/w		Exact identifier — unii candidate 77 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	SUSPENSION / SUBCUTANEOUS	0.02 %w/v		Exact identifier — unii candidate 68 equally ranked IID candidates
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)	CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)	4Q93RCW27E	GEL / OPHTHALMIC	4 %w/w		Exact identifier — unii candidate 9 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	INJECTION / INTRAMUSCULAR	176 mg		Exact identifier — unii candidate 174 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	PASTE / DENTAL	0.6 %w/w		Exact identifier — unii candidate 174 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	TABLET, COATED / ORAL	0.8 mg		Exact identifier — unii candidate 79 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	OINTMENT / TOPICAL		29 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SYSTEM / TOPICAL		4200 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	CREAM / TOPICAL		14 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	EMULSION / TOPICAL	0.2 %w/w		Exact identifier — unii candidate 79 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	EMULSION / OPHTHALMIC	1.5 %w/v		Exact identifier — unii candidate 81 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
A077018-001	METRONIDAZOLE	METRONIDAZOLE	0.75%	GEL / TOPICAL	AB		2006-06-06

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A077018-001	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	A077018-001	METRONIDAZOLE	0.75%	GEL / TOPICAL	AB	2006-06-06	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A077018-001	METRONIDAZOLE	0.75%	GEL / TOPICAL	AB	2006-06-06	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077018-001	METRONIDAZOLE	0.75%	GEL / TOPICAL	AB	2006-06-06	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077018-001	METRONIDAZOLE	0.75%	GEL / TOPICAL	AB	2006-06-06	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077018-001	METRONIDAZOLE	0.75%	GEL / TOPICAL	AB	2006-06-06	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077018-001	METRONIDAZOLE	0.75%	GEL / TOPICAL	AB	2006-06-06	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077018-001	METRONIDAZOLE	0.75%	GEL / TOPICAL	AB	2006-06-06	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077018-001	METRONIDAZOLE	0.75%	GEL / TOPICAL	AB	2006-06-06	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077018-001	METRONIDAZOLE	0.75%	GEL / TOPICAL	AB	2006-06-06	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077018-001	METRONIDAZOLE	0.75%	GEL / TOPICAL	AB	2006-06-06	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077018-001	METRONIDAZOLE	0.75%	GEL / TOPICAL	AB	2006-06-06	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077018-001	METRONIDAZOLE	0.75%	GEL / TOPICAL	AB	2006-06-06	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077018-001	METRONIDAZOLE	0.75%	GEL / TOPICAL	AB	2006-06-06	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077018-001	METRONIDAZOLE	0.75%	GEL / TOPICAL	AB	2006-06-06	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077018-001	METRONIDAZOLE	0.75%	GEL / TOPICAL	AB	2006-06-06	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077018-001	METRONIDAZOLE	0.75%	GEL / TOPICAL	AB	2006-06-06	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077018-001	METRONIDAZOLE	0.75%	GEL / TOPICAL	AB	2006-06-06	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077018-001	METRONIDAZOLE	0.75%	GEL / TOPICAL	AB	2006-06-06	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077018-001	METRONIDAZOLE	0.75%	GEL / TOPICAL	AB	2006-06-06	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077018-001	METRONIDAZOLE	0.75%	GEL / TOPICAL	AB	2006-06-06	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077018-001	METRONIDAZOLE	0.75%	GEL / TOPICAL	AB	2006-06-06	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A077018-001	METRONIDAZOLE	0.75%	GEL / TOPICAL	AB	2006-06-06	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077018-001	METRONIDAZOLE	0.75%	GEL / TOPICAL	AB	2006-06-06	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A077018-001	METRONIDAZOLE	0.75%	GEL / TOPICAL	AB	2006-06-06	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A077018-001	METRONIDAZOLE	0.75%	GEL / TOPICAL	AB	2006-06-06	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A077018-001	METRONIDAZOLE	0.75%	GEL / TOPICAL	AB	2006-06-06	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A077018-001	METRONIDAZOLE	0.75%	GEL / TOPICAL	AB	2006-06-06	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A077018-001	METRONIDAZOLE	0.75%	GEL / TOPICAL	AB	2006-06-06	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A077018-001	METRONIDAZOLE	0.75%	GEL / TOPICAL	AB	2006-06-06	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A077018-001	METRONIDAZOLE	0.75%	GEL / TOPICAL	AB	2006-06-06	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A077018-001	METRONIDAZOLE	0.75%	GEL / TOPICAL	AB	2006-06-06	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A077018-001	METRONIDAZOLE	0.75%	GEL / TOPICAL	AB	2006-06-06	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A077018-001	METRONIDAZOLE	0.75%	GEL / TOPICAL	AB	2006-06-06	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A077018-001	METRONIDAZOLE	0.75%	GEL / TOPICAL	AB	2006-06-06	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A077018-001	METRONIDAZOLE	0.75%	GEL / TOPICAL	AB	2006-06-06	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A077018-001	METRONIDAZOLE	0.75%	GEL / TOPICAL	AB	2006-06-06	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A077018-001	METRONIDAZOLE	0.75%	GEL / TOPICAL	AB	2006-06-06	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A077018-001	METRONIDAZOLE	0.75%	GEL / TOPICAL	AB	2006-06-06	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A077018-001	METRONIDAZOLE	0.75%	GEL / TOPICAL	AB	2006-06-06	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A077018-001	METRONIDAZOLE	0.75%	GEL / TOPICAL	AB	2006-06-06	`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	A077018-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A077018-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077018-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077018-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077018-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077018-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077018-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077018-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077018-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077018-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077018-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077018-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077018-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077018-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077018-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077018-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077018-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077018-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077018-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077018-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077018-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A077018-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077018-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A077018-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A077018-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A077018-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A077018-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A077018-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A077018-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A077018-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A077018-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A077018-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A077018-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A077018-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A077018-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A077018-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A077018-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A077018-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A077018-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A077018-001	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
db216976-bde6-455b-8aba-d89010a78c5c			ab766931-e685-4a81-9939-06da80d9099e	2020-03-12	Adverse reactions	Exact identifier spl set id: ab766931-e685-4a81-9939-06da80d9099e

Reported adverse events (FAERS/openFDA)#

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