Rosadan ® GEL Metronidazole Gel USP, 0.75%

Manufacturer: Medimetriks Pharmaceuticals, Inc. | Cosette Pharmaceuticals, Inc.
Effective date: 2019-11-13
Label type: HUMAN PRESCRIPTION DRUG LABEL
Version: 4
Source: legacy-cache
Hydrated at: 2026-08-02 00:01:22

Label at a glance#

ProductRosadan

Active ingredientmetronidazole

Label structure12 sections

Indications and uses

Rosadan ® (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 Rosadan ® (metronidazole) Gel twice daily, morning and evening, to entire affected areas after washing. Areas to be treated should be cleansed before application of Rosadan ® (metronidazole) Gel. Patients may use cosmetics after application of Rosadan ® (metronidazole) Gel.

Contacts and useful links#

PhoneLabel contact1-973-882-7512

PhoneFDA MedWatch1-800-FDA-1088

Websitewww.fda.gov

www.fda.gov/medwatch

Websitewww.medimetriks.com

www.medimetriks.com

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

FOR TOPICAL USE ONLY (NOT FOR OPHTHALMIC USE)

Rx Only

DESCRIPTION

DESCRIPTION SECTION

Rosadan^® (metronidazole) Gel contains metronidazole, USP, at a concentration of 7.5 mg per gram (0.75%) in a gel consisting of carbomer homopolymer NF, edetate disodium, methylparaben, propylene glycol, propylparaben, purified water, and sodium hydroxide. Metronidazole is classified therapeutically as an antiprotozoal and antibacterial 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 Rosadan^® (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 Rosadan^® (metronidazole) Gel acts in the treatment of rosacea are unknown, but appear to include an anti-inflammatory effect.

INDICATIONS AND USAGE

INDICATIONS & USAGE SECTION

Rosadan^® (metronidazole) Gel is indicated for topical application in the treatment of inflammatory papules and pustules of rosacea.

CONTRAINDICATIONS

CONTRAINDICATIONS SECTION

Rosadan^® (metronidazole) Gel is contraindicated in individuals with a history of hypersensitivity to metronidazole, parabens, or other ingredients of the formulation.

PRECAUTIONS

PRECAUTIONS SECTION

General

GENERAL PRECAUTIONS SECTION

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

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

TERATOGENIC EFFECTS SECTION

Pregnancy category B

SPL UNCLASSIFIED 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

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 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.

To report SUSPECTED ADVERSE REACTIONS, contact Medimetriks Pharmaceuticals, Inc. at 1-973-882-7512 or FDA at 1-800-FDA-1088 orwww.fda.gov/medwatch.

DOSAGE AND ADMINISTRATION

DOSAGE & ADMINISTRATION SECTION

Apply and rub in a thin film of Rosadan ^® (metronidazole) Gel twice daily, morning and evening, to entire affected areas after washing.

Areas to be treated should be cleansed before application of Rosadan ^® (metronidazole) Gel. Patients may use cosmetics after application of Rosadan ^® (metronidazole) Gel.

HOW SUPPLIED

HOW SUPPLIED SECTION

Rosadan ^® (metronidazole) Gel USP, 0.75% is supplied in a 45 g tube NDC 43538-182-45

Storage conditions

STORAGE AND HANDLING SECTION

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

SPL UNCLASSIFIED SECTION

Manufactured for:
MEDIMETRIKS
PHARMACEUTICALS, INC.

383 Route 46 West
Fairfield, NJ 07004-2402
www.medimetriks.com

Manufactured by:
G&W Laboratories, Inc.
South Plainfield, NJ 07080

8-0637BFMDMLNC2
Rev. 08/2019
GW 7313
IP024-R4

PRINCIPAL DISPLAY PANEL - 45 g Tube Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

MEDIMETRIKS
PHARMACEUTICALS, INC.

NDC 43538-182-45

R_x Only

Rosadan_® GEL
Metronidazole Gel USP, 0.75%

NET WT 45 g

PRINCIPAL DISPLAY PANEL - 45 g Tube Carton

PRINCIPAL DISPLAY PANEL - Kit Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 43538-183-45

R_x Only
Rosadan_®
Metronidazole Gel USP, 0.75%
GEL KIT

CONTENTS:

Rosadan^®
Metronidazole Gel USP,
0.75% Tube (Net wt. 45 g)
Rehyla^® Wash
Moisturizing Daily Wash
Bottle (16 fl. oz.)

MEDIMETRIKS
PHARMACEUTICALS, INC.

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
43538-182-45	GM - Gram	43538-182	7f48a560-48a7-4b40-9dbc-bad54129f53e	1	2012-07-24
43538-183-45	EA - Each	43538-183	bf016661-c174-4009-9550-12b3bd3534f6	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
metronidazole	ACTIVE INGREDIENT	140QMO216E	1
metronidazole	ACTIVE MOIETY	140QMO216E	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 · 28 matching rows.

Rosadan
metronidazole
edetate disodium
methylparaben
propylene glycol
propylparaben
water
sodium hydroxide
Rehyla Wash
inert
glyceryl monostearate
glycerin
cetyl alcohol
disodium oleamido mipa-sulfosuccinate
cholesterol
disodium laureth sulfosuccinate
caprylyl glycol
phenoxyethanol
sodium cocoyl isethionate
cocamidopropyl betaine
sodium methyl cocoyl taurate
C13-14 isoparaffin
sodium chloride
niacinamide
hexylene glycol
laureth-7
chamaemelum nobile flower
hyaluronate sodium

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
43538-182	43538-182-45
43538-183	43538-183-45

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 35 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
metronidazole	140QMO216E	ACTIB
edetate disodium	7FLD91C86K	IACT
methylparaben	A2I8C7HI9T	IACT
propylene glycol	6DC9Q167V3	IACT
propylparaben	Z8IX2SC1OH	IACT
water	059QF0KO0R	IACT
sodium hydroxide	55X04QC32I	IACT
metronidazole	140QMO216E	ACTIB
edetate disodium	7FLD91C86K	IACT
methylparaben	A2I8C7HI9T	IACT
propylene glycol	6DC9Q167V3	IACT
propylparaben	Z8IX2SC1OH	IACT
water	059QF0KO0R	IACT
sodium hydroxide	55X04QC32I	IACT
water	059QF0KO0R	INGR
glyceryl monostearate	230OU9XXE4	INGR
glycerin	PDC6A3C0OX	INGR
cetyl alcohol	936JST6JCN	INGR
disodium oleamido mipa-sulfosuccinate	0MBZ20845F	INGR
cholesterol	97C5T2UQ7J	INGR
disodium laureth sulfosuccinate	D6DH1DTN7E	INGR
caprylyl glycol	00YIU5438U	INGR
propylene glycol	6DC9Q167V3	INGR
phenoxyethanol	HIE492ZZ3T	INGR
sodium cocoyl isethionate	518XTE8493	INGR
cocamidopropyl betaine	5OCF3O11KX	INGR
sodium methyl cocoyl taurate	JVL98CG53G	INGR
C13-14 isoparaffin	E4F12ROE70	INGR
sodium chloride	451W47IQ8X	INGR
niacinamide	25X51I8RD4	INGR
edetate disodium	7FLD91C86K	INGR
hexylene glycol	KEH0A3F75J	INGR
laureth-7	Z95S6G8201	INGR
chamaemelum nobile flower	O2T154T6OG	INGR
hyaluronate sodium	YSE9PPT4TH	INGR

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 8 · 479 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 / DENTAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
sodium hydroxide	SODIUM HYDROXIDE	55X04QC32I	POWDER, FOR SOLUTION / ORAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
methylparaben	METHYLPARABEN	A2I8C7HI9T	ELIXIR / ORAL	800 mg		Exact identifier — unii candidate 79 equally ranked IID candidates
sodium hydroxide	SODIUM HYDROXIDE	55X04QC32I	POWDER, FOR SUSPENSION / ORAL		9 mg	Exact identifier — unii candidate 174 equally ranked IID candidates
methylparaben	METHYLPARABEN	A2I8C7HI9T	SOLUTION / TOPICAL		216 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
sodium hydroxide	SODIUM HYDROXIDE	55X04QC32I	INJECTION, SUSPENSION / SOFT TISSUE	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
sodium hydroxide	SODIUM HYDROXIDE	55X04QC32I	INJECTION, POWDER, FOR SOLUTION / RECTAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
sodium hydroxide	SODIUM HYDROXIDE	55X04QC32I	INJECTION, SOLUTION / SUBARACHNOID	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
propylparaben	PROPYLPARABEN	Z8IX2SC1OH	JELLY / NASAL	140 mg		Exact identifier — unii candidate 68 equally ranked IID candidates
sodium hydroxide	SODIUM HYDROXIDE	55X04QC32I	SUSPENSION / AURICULAR (OTIC)	ADJ PH		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
edetate disodium	EDETATE DISODIUM	7FLD91C86K	INJECTION / INTRABURSAL	0.01 %w/v		Exact identifier — unii candidate 77 equally ranked IID candidates
sodium hydroxide	SODIUM HYDROXIDE	55X04QC32I	TABLET, DELAYED RELEASE / ORAL		4 mg	Exact identifier — unii candidate 174 equally ranked IID candidates
sodium hydroxide	SODIUM HYDROXIDE	55X04QC32I	SUSPENSION, EXTENDED RELEASE / INTRA-ARTICULAR	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
methylparaben	METHYLPARABEN	A2I8C7HI9T	SUSPENSION, EXTENDED RELEASE / ORAL		40 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
sodium hydroxide	SODIUM HYDROXIDE	55X04QC32I	INJECTION / INTRA-ARTICULAR	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
methylparaben	METHYLPARABEN	A2I8C7HI9T	SOLUTION / INTRAMUSCULAR	0.13 %w/v		Exact identifier — unii candidate 79 equally ranked IID candidates
methylparaben	METHYLPARABEN	A2I8C7HI9T	SOLUTION/ DROPS / OPHTHALMIC	0.05 %w/v		Exact identifier — unii candidate 79 equally ranked IID candidates
edetate disodium	EDETATE DISODIUM	7FLD91C86K	TABLET, DELAYED RELEASE / ORAL		100 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
sodium hydroxide	SODIUM HYDROXIDE	55X04QC32I	SOLUTION / NASAL	20 mg		Exact identifier — unii candidate 174 equally ranked IID candidates
edetate disodium	EDETATE DISODIUM	7FLD91C86K	GEL / OPHTHALMIC		396 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
sodium hydroxide	SODIUM HYDROXIDE	55X04QC32I	GEL / VAGINAL		20 mg	Exact identifier — unii candidate 174 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	LIQUID / ORAL		162 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	SUSPENSION, EXTENDED RELEASE / ORAL		1000 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
methylparaben	METHYLPARABEN	A2I8C7HI9T	GEL / VAGINAL		8 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
sodium hydroxide	SODIUM HYDROXIDE	55X04QC32I	GRANULE, FOR SUSPENSION / ORAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
sodium hydroxide	SODIUM HYDROXIDE	55X04QC32I	INJECTION / INTRAVITREAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
sodium hydroxide	SODIUM HYDROXIDE	55X04QC32I	SOLUTION / INTRAOCULAR	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
propylparaben	PROPYLPARABEN	Z8IX2SC1OH	INJECTION / PARENTERAL		2 mg	Exact identifier — unii candidate 68 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	ELIXIR / ORAL	200 mg		Exact identifier — unii candidate 68 equally ranked IID candidates
edetate disodium	EDETATE DISODIUM	7FLD91C86K	SOLUTION / INTRAVENOUS	0.05 %w/v		Exact identifier — unii candidate 77 equally ranked IID candidates
methylparaben	METHYLPARABEN	A2I8C7HI9T	POWDER, FOR SUSPENSION / ORAL		75 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
sodium hydroxide	SODIUM HYDROXIDE	55X04QC32I	INJECTION / INTRA-ARTERIAL	176 mg		Exact identifier — unii candidate 174 equally ranked IID candidates
sodium hydroxide	SODIUM HYDROXIDE	55X04QC32I	INJECTION, POWDER, FOR SOLUTION / SUBCUTANEOUS	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
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	AEROSOL, FOAM / RECTAL		1214 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	SYSTEM / TOPICAL		4200 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	INJECTION, SOLUTION / SUBCUTANEOUS	1.4 %w/v		Exact identifier — unii candidate 81 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	SUSPENSION/ DROPS / OPHTHALMIC		1 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
sodium hydroxide	SODIUM HYDROXIDE	55X04QC32I	INJECTION, SUSPENSION / INTRA-ARTICULAR	ADJ PH		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
sodium hydroxide	SODIUM HYDROXIDE	55X04QC32I	INJECTION / INTRACAUDAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
sodium hydroxide	SODIUM HYDROXIDE	55X04QC32I	CAPSULE, LIQUID FILLED / ORAL	1.5 mg		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
propylparaben	PROPYLPARABEN	Z8IX2SC1OH	DROPS / NASAL	14 mg		Exact identifier — unii candidate 68 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	SOLUTION / RESPIRATORY (INHALATION)	25 %w/w		Exact identifier — unii candidate 81 equally ranked IID candidates
sodium hydroxide	SODIUM HYDROXIDE	55X04QC32I	SOLUTION / PERIODONTAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
edetate disodium	EDETATE DISODIUM	7FLD91C86K	CREAM, AUGMENTED / TOPICAL		2 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
methylparaben	METHYLPARABEN	A2I8C7HI9T	SOLUTION / IONTOPHORESIS	0.1 %w/v		Exact identifier — unii candidate 79 equally ranked IID candidates
edetate disodium	EDETATE DISODIUM	7FLD91C86K	SOLUTION / RECTAL		97 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, SUSPENSION / INTRAMUSCULAR	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
sodium hydroxide	SODIUM HYDROXIDE	55X04QC32I	CREAM / TOPICAL		69 mg	Exact identifier — unii candidate 174 equally ranked IID candidates
methylparaben	METHYLPARABEN	A2I8C7HI9T	CAPSULE, EXTENDED RELEASE / ORAL		2 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
sodium hydroxide	SODIUM HYDROXIDE	55X04QC32I	SOLUTION / OPHTHALMIC	0.05 %w/v		Exact identifier — unii candidate 174 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	SUSPENSION / ORAL		27120 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	SOLUTION/ DROPS / OPHTHALMIC	0.75 %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 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
A078178-001	METRONIDAZOLE	METRONIDAZOLE	0.75%	GEL / TOPICAL	AB	RS	2011-01-19

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A078178-001	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	RLD / RS	Approval date	Source SHA-256
2026-10-15 13:18:30	2026-09	A078178-001	METRONIDAZOLE	0.75%	GEL / TOPICAL	AB	RS	2011-01-19	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A078178-001	METRONIDAZOLE	0.75%	GEL / TOPICAL	AB	RS	2011-01-19	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A078178-001	METRONIDAZOLE	0.75%	GEL / TOPICAL	AB	RS	2011-01-19	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078178-001	METRONIDAZOLE	0.75%	GEL / TOPICAL	AB	RS	2011-01-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078178-001	METRONIDAZOLE	0.75%	GEL / TOPICAL	AB	RS	2011-01-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078178-001	METRONIDAZOLE	0.75%	GEL / TOPICAL	AB	RS	2011-01-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078178-001	METRONIDAZOLE	0.75%	GEL / TOPICAL	AB	RS	2011-01-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078178-001	METRONIDAZOLE	0.75%	GEL / TOPICAL	AB	RS	2011-01-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078178-001	METRONIDAZOLE	0.75%	GEL / TOPICAL	AB	RS	2011-01-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078178-001	METRONIDAZOLE	0.75%	GEL / TOPICAL	AB	RS	2011-01-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078178-001	METRONIDAZOLE	0.75%	GEL / TOPICAL	AB	RS	2011-01-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078178-001	METRONIDAZOLE	0.75%	GEL / TOPICAL	AB	RS	2011-01-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078178-001	METRONIDAZOLE	0.75%	GEL / TOPICAL	AB	RS	2011-01-19	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078178-001	METRONIDAZOLE	0.75%	GEL / TOPICAL	AB	RS	2011-01-19	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078178-001	METRONIDAZOLE	0.75%	GEL / TOPICAL	AB	RS	2011-01-19	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078178-001	METRONIDAZOLE	0.75%	GEL / TOPICAL	AB	RS	2011-01-19	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078178-001	METRONIDAZOLE	0.75%	GEL / TOPICAL	AB		2011-01-19	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078178-001	METRONIDAZOLE	0.75%	GEL / TOPICAL	AB		2011-01-19	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078178-001	METRONIDAZOLE	0.75%	GEL / TOPICAL	AB		2011-01-19	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078178-001	METRONIDAZOLE	0.75%	GEL / TOPICAL	AB		2011-01-19	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078178-001	METRONIDAZOLE	0.75%	GEL / TOPICAL	AB		2011-01-19	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078178-001	METRONIDAZOLE	0.75%	GEL / TOPICAL	AB		2011-01-19	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078178-001	METRONIDAZOLE	0.75%	GEL / TOPICAL	AB		2011-01-19	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078178-001	METRONIDAZOLE	0.75%	GEL / TOPICAL	AB		2011-01-19	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A078178-001	METRONIDAZOLE	0.75%	GEL / TOPICAL	AB		2011-01-19	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A078178-001	METRONIDAZOLE	0.75%	GEL / TOPICAL	AB		2011-01-19	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A078178-001	METRONIDAZOLE	0.75%	GEL / TOPICAL	AB		2011-01-19	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A078178-001	METRONIDAZOLE	0.75%	GEL / TOPICAL	AB		2011-01-19	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A078178-001	METRONIDAZOLE	0.75%	GEL / TOPICAL	AB		2011-01-19	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A078178-001	METRONIDAZOLE	0.75%	GEL / TOPICAL	AB		2011-01-19	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A078178-001	METRONIDAZOLE	0.75%	GEL / TOPICAL	AB		2011-01-19	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A078178-001	METRONIDAZOLE	0.75%	GEL / TOPICAL	AB		2011-01-19	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A078178-001	METRONIDAZOLE	0.75%	GEL / TOPICAL	AB		2011-01-19	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A078178-001	METRONIDAZOLE	0.75%	GEL / TOPICAL	AB		2011-01-19	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A078178-001	METRONIDAZOLE	0.75%	GEL / TOPICAL	AB		2011-01-19	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A078178-001	METRONIDAZOLE	0.75%	GEL / TOPICAL	AB		2011-01-19	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A078178-001	METRONIDAZOLE	0.75%	GEL / TOPICAL	AB		2011-01-19	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A078178-001	METRONIDAZOLE	0.75%	GEL / TOPICAL	AB		2011-01-19	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A078178-001	METRONIDAZOLE	0.75%	GEL / TOPICAL	AB		2011-01-19	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A078178-001	METRONIDAZOLE	0.75%	GEL / TOPICAL	AB		2011-01-19	`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	A078178-001	AB	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A078178-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A078178-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078178-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078178-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078178-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078178-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078178-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078178-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078178-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078178-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078178-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078178-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078178-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078178-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078178-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078178-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078178-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078178-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078178-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078178-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078178-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078178-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078178-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A078178-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A078178-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A078178-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A078178-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A078178-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A078178-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A078178-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A078178-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A078178-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A078178-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A078178-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A078178-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A078178-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A078178-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A078178-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A078178-001	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
0af61b42-07f5-4a57-a67d-defe86a15317			99eaa138-0cfa-45e1-abbf-a88271707979	2022-12-07	Adverse reactions	Exact identifier spl set id: 99eaa138-0cfa-45e1-abbf-a88271707979

Reported adverse events (FAERS/openFDA)#

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