Rosadan ® Metronidazole Topical Cream, 0.75%

Manufacturer: Medimetriks Pharmaceuticals, Inc. | Cosette Pharmaceuticals, Inc.
Effective date: 2019-11-13
Label type: HUMAN PRESCRIPTION DRUG LABEL
Version: 3
Source: legacy-cache
Hydrated at: 2026-08-02 00:01:30

Label at a glance#

ProductRosadan

Active ingredientmetronidazole

Label structure12 sections

Indications and uses

Rosadan ® (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 Rosadan ® (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 Rosadan ® (metronidazole) Topical Cream.

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) 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-1H-imidazole-1-ethanol. The molecular formula is C₆H₉N₃O₃ and 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

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

CONTRAINDICATIONS

CONTRAINDICATIONS SECTION

Rosadan^® (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

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 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

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 are no adequate and well-controlled studies with the use of Rosadan^® (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

NURSING MOTHERS 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

PEDIATRIC USE 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 topical metronidazole cream was approximately 10%. 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 Medimetriks Pharmaceuticals, Inc. at 1-973-882-7512 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 Rosadan^® (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 Rosadan^® (metronidazole) Topical Cream.

HOW SUPPLIED

HOW SUPPLIED SECTION

Rosadan^® (metronidazole) Topical Cream, 0.75% is supplied in a 45 g tube NDC 43538-180-45.

Storage conditions

STORAGE AND HANDLING SECTION

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

SPL UNCLASSIFIED SECTION

Manufactured for:
MEDIMETRIKS
PHARMACEUTICALS, INC.
383 Route 46 West, Fairfield, NJ 07004-2402 USA
www.medimetriks.com

Manufactured by:
Cosette Pharmaceuticals, Inc.
111 Coolidge Street,
South Plainfield, NJ 07080

IP019-R5

8-0633MDM5
Rev. 09/2019

PRINCIPAL DISPLAY PANEL - 45 g Tube Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

MEDIMETRIKS
PHARMACEUTICALS, INC.

NDC 43538-180-45

R_x Only
Rosadan_®
Metronidazole Topical Cream, 0.75%

NET WT 45 g

PRINCIPAL DISPLAY PANEL - 45 g Tube Carton

PRINCIPAL DISPLAY PANEL - Kit Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 43538-181-45

R_x Only
Rosadan _®
Metronidazole Topical Cream, 0.75%
CREAM KIT

CONTENTS:
1- Rosadan^®
Metronidazole Topical Cream,
0.75% Tube (Net wt. 45 g)
1- 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
43538-180-45	GM - Gram	43538-180	1d9f3852-75c4-4999-813b-080721eb0b83	1	2012-07-24
43538-181-45	EA - Each	43538-181	24432fa4-d702-40b7-8f25-0a1758644441	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
benzyl alcohol	INACTIVE INGREDIENT	LKG8494WBH	1
glycerin	INACTIVE INGREDIENT	PDC6A3C0OX	1
isopropyl palmitate	INACTIVE INGREDIENT	8CRQ2TH63M	1
lactic acid	INACTIVE INGREDIENT	33X04XA5AT	1
sodium hydroxide	INACTIVE INGREDIENT	55X04QC32I	1
sorbitol	INACTIVE INGREDIENT	506T60A25R	1
water	INACTIVE INGREDIENT	059QF0KO0R	1

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

Rosadan
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
43538-180	43538-180-45
43538-181	43538-181-45

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
metronidazole	140QMO216E	ACTIB
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
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

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 7 · 369 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
glycerin	GLYCERIN	PDC6A3C0OX	INJECTION / SUBCUTANEOUS		450 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
sodium hydroxide	SODIUM HYDROXIDE	55X04QC32I	OINTMENT / TOPICAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
sodium hydroxide	SODIUM HYDROXIDE	55X04QC32I	INJECTION / PARENTERAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
glycerin	GLYCERIN	PDC6A3C0OX	SUSPENSION/ DROPS / OPHTHALMIC	2.5 %w/v		Exact identifier — unii candidate 75 equally ranked IID candidates
sodium hydroxide	SODIUM HYDROXIDE	55X04QC32I	SYRUP / ORAL	71 mg/5ml		Exact identifier — unii candidate 174 equally ranked IID candidates
sodium hydroxide	SODIUM HYDROXIDE	55X04QC32I	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAMUSCULAR	0.35 %w/v		Exact identifier — unii candidate 174 equally ranked IID candidates
sorbitol	SORBITOL	506T60A25R	SYRUP / ORAL	4370 mg/5ml		Exact identifier — unii candidate 44 equally ranked IID candidates
sodium hydroxide	SODIUM HYDROXIDE	55X04QC32I	CAPSULE, COATED PELLETS / ORAL	0.01 mg		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
glycerin	GLYCERIN	PDC6A3C0OX	DROPS / ORAL	300 mg/1ml		Exact identifier — unii candidate 75 equally ranked IID candidates
benzyl alcohol	BENZYL ALCOHOL	LKG8494WBH	CAPSULE, EXTENDED RELEASE / ORAL	1.23 mg		Exact identifier — unii candidate 50 equally ranked IID candidates
isopropyl palmitate	ISOPROPYL PALMITATE	8CRQ2TH63M	OINTMENT / TOPICAL	NA		Exact identifier — unii candidate 8 equally ranked IID candidates
glycerin	GLYCERIN	PDC6A3C0OX	SOLUTION / OPHTHALMIC	6 %w/v		Exact identifier — unii candidate 75 equally ranked IID candidates
lactic acid	LACTIC ACID	33X04XA5AT	INJECTION / SUBCUTANEOUS		10 mg	Exact identifier — unii candidate 18 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	OINTMENT, AUGMENTED / TOPICAL	0.11 %w/w		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
benzyl alcohol	BENZYL ALCOHOL	LKG8494WBH	INJECTION / SOFT TISSUE		23 mg	Exact identifier — unii candidate 50 equally ranked IID candidates
sorbitol	SORBITOL	506T60A25R	PASTE, DENTIFRICE / DENTAL	14 %w/w		Exact identifier — unii candidate 44 equally ranked IID candidates
sodium hydroxide	SODIUM HYDROXIDE	55X04QC32I	LIQUID / INTRAMUSCULAR	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
sorbitol	SORBITOL	506T60A25R	INJECTION / INTRAVENOUS		1276 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
sodium hydroxide	SODIUM HYDROXIDE	55X04QC32I	SOLUTION / OPHTHALMIC	0.05 %w/v		Exact identifier — unii candidate 174 equally ranked IID candidates
sodium hydroxide	SODIUM HYDROXIDE	55X04QC32I	LOTION / TOPICAL		21 mg	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
sodium hydroxide	SODIUM HYDROXIDE	55X04QC32I	INJECTION / INTRA-ARTICULAR	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
benzyl alcohol	BENZYL ALCOHOL	LKG8494WBH	INJECTION / INTRAMUSCULAR		1000 mg	Exact identifier — unii candidate 50 equally ranked IID candidates
sorbitol	SORBITOL	506T60A25R	TABLET, DELAYED RELEASE / ORAL	0.01 mg		Exact identifier — unii candidate 44 equally ranked IID candidates
glycerin	GLYCERIN	PDC6A3C0OX	INJECTION, SOLUTION / INTRAVENOUS	15 %w/v		Exact identifier — unii candidate 75 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	INJECTION / ENDOTRACHEAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
sodium hydroxide	SODIUM HYDROXIDE	55X04QC32I	INJECTION / INTRAPLEURAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
benzyl alcohol	BENZYL ALCOHOL	LKG8494WBH	INJECTION, SUSPENSION / INTRA-ARTICULAR		40 mg	Exact identifier — unii candidate 50 equally ranked IID candidates
sodium hydroxide	SODIUM HYDROXIDE	55X04QC32I	INJECTION, SOLUTION / PARENTERAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
sodium hydroxide	SODIUM HYDROXIDE	55X04QC32I	SOLUTION, CONCENTRATE / INTRAVENOUS	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
sodium hydroxide	SODIUM HYDROXIDE	55X04QC32I	INJECTION, SUSPENSION / SUBCUTANEOUS	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
sodium hydroxide	SODIUM HYDROXIDE	55X04QC32I	INJECTION, SOLUTION / INTRAVESICAL	ADJ PH		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
sodium hydroxide	SODIUM HYDROXIDE	55X04QC32I	INJECTION, SUSPENSION / INTRAMUSCULAR	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
sodium hydroxide	SODIUM HYDROXIDE	55X04QC32I	DROPS / OPHTHALMIC	NA		Exact identifier — unii candidate 174 equally ranked IID candidates
sodium hydroxide	SODIUM HYDROXIDE	55X04QC32I	TABLET, FILM COATED / ORAL		8 mg	Exact identifier — unii candidate 174 equally ranked IID candidates
sorbitol	SORBITOL	506T60A25R	TABLET / SUBLINGUAL	50.5 mg		Exact identifier — unii candidate 44 equally ranked IID candidates
benzyl alcohol	BENZYL ALCOHOL	LKG8494WBH	CREAM / VAGINAL	1 %w/w		Exact identifier — unii candidate 50 equally ranked IID candidates
sodium hydroxide	SODIUM HYDROXIDE	55X04QC32I	PASTE / DENTAL	0.6 %w/w		Exact identifier — unii candidate 174 equally ranked IID candidates
sorbitol	SORBITOL	506T60A25R	LIQUID / TOPICAL	1 %w/w		Exact identifier — unii candidate 44 equally ranked IID candidates
benzyl alcohol	BENZYL ALCOHOL	LKG8494WBH	INJECTION, POWDER, FOR SOLUTION / INTRAMUSCULAR	144 mg		Exact identifier — unii candidate 50 equally ranked IID candidates
sodium hydroxide	SODIUM HYDROXIDE	55X04QC32I	SWAB / TOPICAL	0.01 %w/w		Exact identifier — unii candidate 174 equally ranked IID candidates
sorbitol	SORBITOL	506T60A25R	CONCENTRATE / ORAL	600 mg/1ml		Exact identifier — unii candidate 44 equally ranked IID candidates
sodium hydroxide	SODIUM HYDROXIDE	55X04QC32I	INJECTION / SOFT TISSUE	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
glycerin	GLYCERIN	PDC6A3C0OX	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS	225 mg		Exact identifier — unii candidate 75 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
sorbitol	SORBITOL	506T60A25R	INJECTION, SOLUTION / INTRAVENOUS		4050 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
glycerin	GLYCERIN	PDC6A3C0OX	SOLUTION, CONCENTRATE / ORAL	200 mg/1ml		Exact identifier — unii candidate 75 equally ranked IID candidates
sodium hydroxide	SODIUM HYDROXIDE	55X04QC32I	SPRAY / NASAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
benzyl alcohol	BENZYL ALCOHOL	LKG8494WBH	INJECTION, SOLUTION / INTRAVENOUS		400 mg	Exact identifier — unii candidate 50 equally ranked IID candidates
lactic acid	LACTIC ACID	33X04XA5AT	CONCENTRATE / ORAL	50 mg/5ml		Exact identifier — unii candidate 18 equally ranked IID candidates
sodium hydroxide	SODIUM HYDROXIDE	55X04QC32I	GRANULE, FOR SUSPENSION / ORAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
benzyl alcohol	BENZYL ALCOHOL	LKG8494WBH	LOTION / TOPICAL		4000 mg	Exact identifier — unii candidate 50 equally ranked IID candidates
sodium hydroxide	SODIUM HYDROXIDE	55X04QC32I	INJECTION, POWDER, FOR SOLUTION / INTRA-ARTERIAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
isopropyl palmitate	ISOPROPYL PALMITATE	8CRQ2TH63M	LOTION / TOPICAL	5 %w/w		Exact identifier — unii candidate 8 equally ranked IID candidates
glycerin	GLYCERIN	PDC6A3C0OX	TABLET, COATED / ORAL	1 mg		Exact identifier — unii candidate 75 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
95869afd-d0a6-43f8-b42a-a767c9f5fe56			85a9ba62-eeb8-419e-a21f-e3db1eda7fc4	2022-12-07	Adverse reactions	Exact identifier spl set id: 85a9ba62-eeb8-419e-a21f-e3db1eda7fc4

Reported adverse events (FAERS/openFDA)#

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