Metronidazole

Manufacturer: Amneal Pharmaceuticals of New York LLC | TOLMAR Inc.
Effective date: 2019-06-01
Label type: HUMAN PRESCRIPTION DRUG LABEL
Version: 5
Source: legacy-cache
Hydrated at: 2026-08-02 00:22:55

Label at a glance#

ProductMetronidazole

Active ingredientMETRONIDAZOLE

Label structure9 sections

Indications and uses

Metronidazole gel USP (topical), 0.75%, 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 USP (topical), 0.75%, twice daily, morning and evening, to entire affected areas after washing. Areas to be treated should be cleansed before application of metronidazole gel USP (topical), 0.75%. Patients may use cosmetics after application of metronidazole gel USP (topical), 0.75%.

Contacts and useful links#

PhoneLabel contact1-877-835-5472

PhoneFDA MedWatch1-800-FDA-1088

Websitewww.fda.gov

www.fda.gov/medwatch

Label contents#

Full prescribing information#

DESCRIPTION

DESCRIPTION SECTION

Metronidazole gel USP (topical), 0.75%, contains metronidazole, at a concentration of 7.5 mg per gram (0.75%) in a gel consisting of carbopol 980, edetate disodium, methylparaben, propylene glycol, propylparaben, purified water, and sodium hydroxide. Metronidazole is classified therapeutically as an antiprotozoal and anti-bacterial agent. Chemically, metronidazole is named 2-methyl-5-nitro-1H-imidazole-1-ethanol and has the following structure:

CLINICAL PHARMACOLOGY

CLINICAL PHARMACOLOGY SECTION

Bioavailability studies on the topical administration of 1 gram of metronidazole gel USP (topical), 0.75%, (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 USP (topical), 0.75%, acts in the treatment of rosacea are unknown, but appear to include an anti-inflammatory effect.

INDICATIONS AND USAGE

INDICATIONS & USAGE SECTION

Metronidazole gel USP (topical), 0.75%, is indicated for topical application in the treatment of inflammatory papules and pustules of rosacea.

CONTRAINDICATIONS

CONTRAINDICATIONS SECTION

Metronidazole gel USP (topical), 0.75%, is contraindicated in individuals with a history of hypersensitivity to metronidazole, parabens, or other ingredients of the formulation.

PRECAUTIONS

PRECAUTIONS SECTION

General: Metronidazole gel USP (topical), 0.75%, 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

INFORMATION FOR PATIENTS 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

DRUG INTERACTIONS SECTION

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

PREGNANCY SECTION

Teratogenic effects: Pregnancy category B: There has been no experience to date with the use of metronidazole gel USP (topical), 0.75%, 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

NURSING MOTHERS SECTION

After oral administration, metronidazole is secreted in breast milk in concentrations similar to those found in the plasma. Even though metronidazole gel USP (topical), 0.75%, 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

PEDIATRIC USE SECTION

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.

DOSAGE AND ADMINISTRATION

DOSAGE & ADMINISTRATION SECTION

Apply and rub in a thin film of metronidazole gel USP (topical), 0.75%, twice daily, morning and evening, to entire affected areas after washing.

Areas to be treated should be cleansed before application of metronidazole gel USP (topical), 0.75%. Patients may use cosmetics after application of metronidazole gel USP (topical), 0.75%.

HOW SUPPLIED

HOW SUPPLIED SECTION

Metronidazole gel USP (topical), 0.75%, is supplied as the following:

NDC 0115-1474-46: 45 g aluminum tube

Storage and Handling

STORAGE AND HANDLING SECTION

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

To report SUSPECTED ADVERSE REACTIONS contact Amneal Pharmaceuticals at 1-877-835-5472 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Manufactured by:
Tolmar, Inc.
Fort Collins, CO 80526

Distributed by:
Amneal Pharmaceuticals LLC
Bridgewater, NJ 08807

04006127 Rev. 0 04/19

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0115-1474-46	GM - Gram	0115-1474	d482fdc9-38ad-4ac9-a86d-a2d769108913	1	2013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
METRONIDAZOLE	ACTIVE INGREDIENT	140QMO216E	1
METRONIDAZOLE	ACTIVE MOIETY	140QMO216E	1
CARBOMER HOMOPOLYMER TYPE C	INACTIVE INGREDIENT	4Q93RCW27E	1
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	1
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	1
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	1
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	1

Products#

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

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

Metronidazole
CARBOMER HOMOPOLYMER TYPE C
METHYLPARABEN
PROPYLPARABEN
EDETATE DISODIUM
PROPYLENE GLYCOL
SODIUM HYDROXIDE
WATER

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
0115-1474	0115-1474-46

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
CARBOMER HOMOPOLYMER TYPE C	4Q93RCW27E	IACT
METHYLPARABEN	A2I8C7HI9T	IACT
PROPYLPARABEN	Z8IX2SC1OH	IACT
EDETATE DISODIUM	7FLD91C86K	IACT
PROPYLENE GLYCOL	6DC9Q167V3	IACT
SODIUM HYDROXIDE	55X04QC32I	IACT
WATER	059QF0KO0R	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
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	OINTMENT / DENTAL	NA		Exact identifier — unii candidate 81 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	SUSPENSION/ DROPS / AURICULAR (OTIC)	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS		19 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	CAPSULE, EXTENDED RELEASE / ORAL	0.22 mg		Exact identifier — unii candidate 68 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	INJECTION / SUBCONJUNCTIVAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	GEL / TRANSDERMAL		472 mg	Exact identifier — unii candidate 174 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	POWDER / ORAL	NA		Exact identifier — unii candidate 79 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	AEROSOL, FOAM / TOPICAL	0.04 %w/w		Exact identifier — unii candidate 68 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	ELIXIR / ORAL	200 mg		Exact identifier — unii candidate 68 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	POWDER, FOR SOLUTION / ORAL		126 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SUSPENSION/ DROPS / ORAL		4 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
CARBOMER HOMOPOLYMER TYPE C	CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)	4Q93RCW27E	CREAM / TOPICAL		103 mg	Exact identifier — unii candidate 9 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	INJECTION / INFILTRATION	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	DROPS / NASAL	26 mg		Exact identifier — unii candidate 79 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SOLUTION / TOPICAL		216 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	ENEMA / RECTAL		60 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	INJECTION / INTRACAUDAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	TABLET / ORAL		100 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	TABLET, CHEWABLE / ORAL	0.14 mg		Exact identifier — unii candidate 68 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	INJECTION / INTERSTITIAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SOLUTION/ DROPS / OPHTHALMIC	0.05 %w/v		Exact identifier — unii candidate 79 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	SOLUTION / RECTAL	NA		Exact identifier — unii candidate 174 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	INJECTION / SUBCUTANEOUS		6 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	CONCENTRATE / ORAL		20 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	POWDER / ORAL	NA		Exact identifier — unii candidate 68 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SUSPENSION / ORAL		30 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	CREAM / VAGINAL		22 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	AEROSOL, FOAM / TOPICAL	0.05 %w/w		Exact identifier — unii candidate 77 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	CAPSULE / ORAL		1072 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	LIQUID / NASAL	2 mg/1ml		Exact identifier — unii candidate 77 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SOLUTION / ORAL		432 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	INJECTION, POWDER, FOR SOLUTION / INTRATUMOR	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	CAPSULE, COATED, EXTENDED RELEASE / ORAL	NA		Exact identifier — unii candidate 81 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	GEL, METERED / TRANSDERMAL		350 mg	Exact identifier — unii candidate 174 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRACAVERNOUS	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	TABLET, COATED / ORAL	NA		Exact identifier — unii candidate 174 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	TABLET, DELAYED RELEASE / ORAL		100 mg	Exact identifier — unii candidate 77 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	TABLET, EXTENDED RELEASE / ORAL		10 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / PARENTERAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SPRAY / TOPICAL	0.2 %w/w		Exact identifier — unii candidate 79 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	SUSPENSION, EXTENDED RELEASE / INTRADERMAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS	NA		Exact identifier — unii candidate 174 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	LIQUID / INTRAMUSCULAR	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	CREAM / VAGINAL		1225 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	SUSPENSION / SUBCUTANEOUS	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	SPRAY, METERED / NASAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	INJECTION, SOLUTION / SUBMUCOSAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	AEROSOL, FOAM / VAGINAL	6.4 %w/w		Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	CONCENTRATE / ORAL	2.5 mg/5ml		Exact identifier — unii candidate 68 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	EMULSION / TOPICAL	0.2 %w/w		Exact identifier — unii candidate 174 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	GEL / OPHTHALMIC		6 mg	Exact identifier — unii candidate 174 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SUSPENSION / OPHTHALMIC	0.06 %w/v		Exact identifier — unii candidate 77 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	INJECTION / INTRABURSAL	0.01 %w/v		Exact identifier — unii candidate 77 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	GEL / TOPICAL		24 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	INJECTION / SOFT TISSUE	0.15 %w/v		Exact identifier — unii candidate 79 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	INJECTION / SOFT TISSUE	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
CARBOMER HOMOPOLYMER TYPE C	CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)	4Q93RCW27E	GEL, METERED / TRANSDERMAL		50 mg	Exact identifier — unii candidate 9 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SOLUTION/ DROPS / AURICULAR (OTIC)	ADJ PH		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 44.

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
A077547-001	METRONIDAZOLE	METRONIDAZOLE	0.75%	GEL / TOPICAL	AB		2006-07-13

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A077547-001	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 · 44 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
2026-10-15 13:18:30	2026-09	A077547-001	METRONIDAZOLE	0.75%	GEL / TOPICAL	AB	2006-07-13	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A077547-001	METRONIDAZOLE	0.75%	GEL / TOPICAL	AB	2006-07-13	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A077547-001	METRONIDAZOLE	0.75%	GEL / TOPICAL	AB	2006-07-13	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077547-001	METRONIDAZOLE	0.75%	GEL / TOPICAL	AB	2006-07-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077547-001	METRONIDAZOLE	0.75%	GEL / TOPICAL	AB	2006-07-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077547-001	METRONIDAZOLE	0.75%	GEL / TOPICAL	AB	2006-07-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077547-001	METRONIDAZOLE	0.75%	GEL / TOPICAL	AB	2006-07-13	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077547-001	METRONIDAZOLE	0.75%	GEL / TOPICAL	AB	2006-07-13	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077547-001	METRONIDAZOLE	0.75%	GEL / TOPICAL	AB	2006-07-13	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077547-001	METRONIDAZOLE	0.75%	GEL / TOPICAL	AB	2006-07-13	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077547-001	METRONIDAZOLE	0.75%	GEL / TOPICAL	AB	2006-07-13	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077547-001	METRONIDAZOLE	0.75%	GEL / TOPICAL	AB	2006-07-13	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077547-001	METRONIDAZOLE	0.75%	GEL / TOPICAL	AB	2006-07-13	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077547-001	METRONIDAZOLE	0.75%	GEL / TOPICAL	AB	2006-07-13	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077547-001	METRONIDAZOLE	0.75%	GEL / TOPICAL	AB	2006-07-13	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077547-001	METRONIDAZOLE	0.75%	GEL / TOPICAL	AB	2006-07-13	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077547-001	METRONIDAZOLE	0.75%	GEL / TOPICAL	AB	2006-07-13	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077547-001	METRONIDAZOLE	0.75%	GEL / TOPICAL	AB	2006-07-13	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077547-001	METRONIDAZOLE	0.75%	GEL / TOPICAL	AB	2006-07-13	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077547-001	METRONIDAZOLE	0.75%	GEL / TOPICAL	AB	2006-07-13	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077547-001	METRONIDAZOLE	0.75%	GEL / TOPICAL	AB	2006-07-13	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077547-001	METRONIDAZOLE	0.75%	GEL / TOPICAL	AB	2006-07-13	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A077547-001	METRONIDAZOLE	0.75%	GEL / TOPICAL	AB	2006-07-13	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077547-001	METRONIDAZOLE	0.75%	GEL / TOPICAL	AB	2006-07-13	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A077547-001	METRONIDAZOLE	0.75%	GEL / TOPICAL	AB	2006-07-13	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A077547-001	METRONIDAZOLE	0.75%	GEL / TOPICAL	AB	2006-07-13	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A077547-001	METRONIDAZOLE	0.75%	GEL / TOPICAL	AB	2006-07-13	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A077547-001	METRONIDAZOLE	0.75%	GEL / TOPICAL	AB	2006-07-13	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A077547-001	METRONIDAZOLE	0.75%	GEL / TOPICAL	AB	2006-07-13	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A077547-001	METRONIDAZOLE	0.75%	GEL / TOPICAL	AB	2006-07-13	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A077547-001	METRONIDAZOLE	0.75%	GEL / TOPICAL	AB	2006-07-13	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A077547-001	METRONIDAZOLE	0.75%	GEL / TOPICAL	AB	2006-07-13	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A077547-001	METRONIDAZOLE	0.75%	GEL / TOPICAL	AB	2006-07-13	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A077547-001	METRONIDAZOLE	0.75%	GEL / TOPICAL	AB	2006-07-13	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A077547-001	METRONIDAZOLE	0.75%	GEL / TOPICAL	AB	2006-07-13	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A077547-001	METRONIDAZOLE	0.75%	GEL / TOPICAL	AB	2006-07-13	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A077547-001	METRONIDAZOLE	0.75%	GEL / TOPICAL	AB	2006-07-13	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A077547-001	METRONIDAZOLE	0.75%	GEL / TOPICAL	AB	2006-07-13	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A077547-001	METRONIDAZOLE	0.75%	GEL / TOPICAL	AB	2006-07-13	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A077547-001	METRONIDAZOLE	0.75%	GEL / TOPICAL	AB	2006-07-13	`3a93d1ddd44b…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 44 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	A077547-001	AB	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A077547-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A077547-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A077547-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077547-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077547-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077547-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077547-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077547-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077547-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077547-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077547-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077547-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077547-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077547-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077547-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077547-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077547-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077547-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077547-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077547-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077547-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A077547-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A077547-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A077547-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A077547-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A077547-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A077547-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A077547-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A077547-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A077547-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A077547-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A077547-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A077547-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A077547-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A077547-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A077547-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A077547-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A077547-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A077547-001	AB	1	`3a93d1ddd44b…`

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
98e8d640-aff9-41bd-af70-1fd3a138c262			2ede12d7-421c-4580-93ad-289a5c616297	2024-01-24	Adverse reactions	Exact identifier spl set id: 2ede12d7-421c-4580-93ad-289a5c616297

Reported adverse events (FAERS/openFDA)#

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