Metronidazole
- Manufacturer
- Sandoz Inc. | TOLMAR, INC.
- Effective date
- 2022-04-01
- Label type
- HUMAN PRESCRIPTION DRUG LABEL
- Version
- 9
- Source
- legacy-cache
- Hydrated at
- 2026-08-01 21:12:45
Label at a glance#
ProductMetronidazole
Active ingredientMETRONIDAZOLE
Label structure16 sections
Contacts and useful links#
Websitewww.fda.gov
www.fda.gov/medwatch
www.fda.gov/medwatchLabel contents#
Full prescribing information#
1 INDICATIONS & USAGE
Metronidazole gel USP, 1% is indicated for the topical treatment of inflammatory lesions of rosacea.
2 DOSAGE & ADMINISTRATION
For topical use only, not for oral, ophthalmic, or intravaginal use.
Cleanse treated areas before the application of metronidazole gel USP, 1%.
Apply and rub in a thin film of metronidazole gel USP, 1% once daily to affected area(s).
Cosmetics may be applied after the application of metronidazole gel USP, 1%.
3 DOSAGE FORMS & STRENGTHS
Gel, 1%. Metronidazole gel USP, 1% is a clear, colorless to pale yellow gel. Each gram of metronidazole gel USP, 1% contains 10 mg (1%) of metronidazole.
4 CONTRAINDICATIONS
Metronidazole gel USP, 1% is contraindicated in patients with a history of hypersensitivity to metronidazole or to any other ingredient in the formulation.
5 WARNINGS AND PRECAUTIONS
5.1 Neurologic Disease
Peripheral neuropathy, characterized by numbness or paresthesia of an extremity, has been reported in patients treated with systemic metronidazole. Peripheral neuropathy has been reported with the post approval use of topical metronidazole. The appearance of abnormal neurologic signs should prompt immediate reevaluation of metronidazole gel USP, 1% therapy. Metronidazole should be administered with caution to patients with central nervous system diseases.
5.2 Blood Dyscrasias
Metronidazole gel USP, 1% is a nitroimidazole; use with care in patients with evidence of, or history of, blood dyscrasia.
5.3 Contact Dermatitis
Irritant and allergic contact dermatitis have been reported with metronidazole gel USP, 1%. If dermatitis occurs, patients may need to discontinue use.
5.4 Eye Irritation
Topical metronidazole has been reported to cause tearing of the eyes. Avoid contact with the eyes.
6 ADVERSE REACTIONS
6.1 Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
In a controlled clinical trial, 557 subjects used metronidazole gel USP, 1% and 189 subjects used the gel vehicle once daily for up to 10 weeks. The following table summarizes selected adverse reactions that occurred at a rate of ≥1%:
Table 1: Adverse Reactions That Occurred at a Rate of ≥1%
| System Organ Class/Preferred Term | Metronidazole Gel USP, 1% | Vehicle |
| N= 557 | N= 189 | |
| Patients with at least one AE Number (%) of Patients | 186 (33.4) | 51 (27.0) |
| Infections and infestations | 76 (13.6) | 28 (14.8) |
| Bronchitis | 6 (1.1) | 3 (1.6) |
| Influenza | 8 (1.4) | 1 (0.5) |
| Nasopharyngitis | 17 (3.1) | 8 (4.2) |
| Sinusitis | 8 (1.4) | 3 (1.6) |
| Upper respiratory tract infection | 14 (2.5) | 4 (2.1) |
| Urinary tract infection | 6 (1.1) | 1 (0.5) |
| Vaginal mycosis | 1 (0.2) | 2 (1.1) |
| Musculoskeletal and connective tissue disorders | 19 (3.4) | 5 (2.6) |
| Back pain | 3 (0.5) | 2 (1.1) |
| Neoplasms | 4 (0.7) | 2 (1.1) |
| Basal cell carcinoma | 1 (0.2) | 2 (1.1) |
| Nervous system disorders | 18 (3.2) | 3 (1.6) |
| Headache | 12 (2.2) | 1 (0.5) |
| Respiratory, thoracic and mediastinal disorders | 22 (3.9) | 5 (2.6) |
| Nasal congestion | 6 (1.1) | 3 (1.6) |
| Skin and subcutaneous tissue disorders | 36 (6.5) | 12 (6.3) |
| Contact dermatitis | 7 (1.3) | 1 (0.5) |
| Dry skin | 6 (1.1) | 3 (1.6) |
| Vascular disorders | 8 (1.4) | 1 (0.5) |
| Hypertension | 6 (1.1) | 1 (0.5) |
Table 2: Local Cutaneous Signs and Symptoms of Irritation That Were Worse Than Baseline
| Metronidazole Gel USP, 1% | Vehicle | |
| Sign/Symptom | N= 544 | N= 184 |
| Dryness | 138 (25.4) | 63 (34.2) |
| Mild | 93 (17.1) | 41 (22.3) |
| Moderate | 42 (7.7) | 20 (10.9) |
| Severe | 3 (0.6) | 2 (1.1) |
| Scaling | 134 (24.6) | 60 (32.6) |
| Mild | 88 (16.2) | 32 (17.4) |
| Moderate | 43 (7.9) | 27 (14.7) |
| Severe | 3 (0.6) | 1 (0.5) |
| Pruritus | 86 (15.8) | 35 (19.0) |
| Mild | 53 (9.7) | 21 (11.4) |
| Moderate | 27 (5.0) | 13 (7.1) |
| Severe | 6 (1.1) | 1 (0.5) |
| Stinging/burning | 56 (10.3) | 28 (15.2) |
| Mild | 39 (7.2) | 18 (9.8) |
| Moderate | 7 (1.3) | 9 (4.9) |
| Severe | 10 (1.8) | 1 (0.5) |
The following additional adverse experiences have been reported with the topical use of metronidazole: transient redness, metallic taste, tingling or numbness of extremities, and nausea.
6.2 Post Marketing Experience
The following adverse reaction has been identified during post-approval use of topical metronidazole. Because this reaction is reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate the frequency or establish a causal relationship to drug exposure.
Nervous System Disorders: Peripheral neuropathy [see Warnings and Precautions (5.1)]
7 DRUG INTERACTIONS
Oral metronidazole has been reported to potentiate the anticoagulant effect of coumarin and warfarin, resulting in a prolongation of prothrombin time. Drug interactions should be kept in mind when metronidazole gel USP, 1% is prescribed for patients who are receiving anticoagulant treatment, although they are less likely to occur with topical metronidazole administration because of low absorption.
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
Risk Summary
Available data have not established an association with metronidazole use during pregnancy and major birth defects, miscarriage or other adverse maternal or fetal outcomes. No fetotoxicity was observed after oral administration of metronidazole in pregnant rats or mice. The available data do not allow the calculation of relevant comparisons between the systemic exposures of metronidazole observed in animal studies to the systemic exposures that would be expected in humans after topical use of metronidazole gel USP, 1%.
The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.
8.2 Lactation
Risk Summary
It is not known whether metronidazole is present in human milk after topical administration. Published literature reports the presence of metronidazole in human milk after oral administration. There are reports of diarrhea and candida infection in breastfed infants of mothers receiving oral treatment with metronidazole. There are no data on the effects of metronidazole on milk production. Because of the potential for serious adverse reactions, advise patients that breastfeeding is not recommended during treatment with metronidazole gel USP, 1%.
8.4 Pediatric Use
Safety and effectiveness in pediatric patients have not been established.
8.5 Geriatric Use
Sixty-six subjects aged 65 years and older were treated with metronidazole gel USP, 1% in the clinical study. No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.
11 DESCRIPTION
Metronidazole gel USP, 1% contains metronidazole, USP. It is intended for topical use. Chemically, metronidazole is 2-methyl-5-nitro-1 H-imidazole-1-ethanol. The molecular formula for metronidazole is C6H9N3O3. It has the following structural formula:
Metronidazole has a molecular weight of 171.16. It is a white to pale yellow crystalline powder. It is slightly soluble in alcohol and has solubility in water of 10 mg/mL at 20°C. Metronidazole belongs to the nitroimidazole class of compounds.
Metronidazole gel USP, 1% is a clear, colorless to pale yellow, aqueous gel; each gram contains 10 mg of metronidazole in a base of ceteth-20, edetate disodium, hydroxyethyl cellulose, methylparaben, niacinamide, phenoxyethanol, propylene glycol, propylparaben and purified water.
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
The mechanism of action of metronidazole in the treatment of rosacea is unknown.
12.2 Pharmacodynamics
The pharmacodynamics of metronidazole in association with the treatment of rosacea are unknown.
Cardiac Electrophysiology: The effect of metronidazole gel USP, 1% on the QTc interval has not been adequately characterized.
12.3 Pharmacokinetics
Topical administration of a one-gram dose of metronidazole gel USP, 1% to the face of 13 subjects with moderate to severe rosacea once daily for 7 days resulted in a mean ± SD Cmax of metronidazole of 32 ± 9 ng/mL. The mean ± SD AUC(0-24) was 595 ± 154 ng*hr/mL. The mean Cmax and AUC(0-24) are less than 1% of the value reported for a single 250 mg oral dose of metronidazole. The time to maximum plasma concentration (Tmax) was 6 to 10 hours after topical application.
13 NONCLINICAL TOXICOLOGY
13.1 CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY
Metronidazole has shown evidence of carcinogenic activity in studies involving chronic oral administration in mice and rats, but not in studies involving hamsters.
In several long-term studies in mice, oral doses of approximately 225 mg/m2/day or greater were associated with an increase in pulmonary tumors and lymphomas. Several long-term oral studies in the rat have shown statistically significant increases in mammary and hepatic tumors at doses >885 mg/m2/day.
Metronidazole has shown evidence of mutagenic activity in several in vitro bacterial assay systems. In addition, a dose-related increase in the frequency of micronuclei was observed in mice after intraperitoneal injections. An increase in chromosomal aberrations in peripheral blood lymphocytes was reported in patients with Crohn's disease who were treated with 200 to 1200 mg/day of metronidazole for 1 to 24 months. However, in another study, no increase in chromosomal aberrations in circulating lymphocytes was observed in patients with Crohn’s disease treated with the drug for 8 months.
14 CLINICAL STUDIES
In a randomized, vehicle-controlled trial, 746 subjects with rosacea were treated with metronidazole gel USP, 1% or vehicle once daily for 10 weeks. Most subjects had a disease severity score of 3 (“moderate”) on the 5-point Investigator Global Assessment (IGA) scale, with 8 to 50 inflammatory lesions and no more than two nodules at baseline. The co-primary efficacy endpoints were the percent reduction in inflammatory lesion counts and percentage of subjects with success on IGA, defined as an IGA score of 0 (“clear”) or 1 ( “almost clear”) at Week 10.
The efficacy results are shown in the following table:
Table 3: Inflammatory Lesion Counts and Global Scores in a Clinical Trial of Rosacea
| Metronidazole Gel USP, 1% | Vehicle | |||
| N | Results N (%) | N | Results N (%) | |
| Inflammatory lesions | 557 | 189 | ||
| Baseline, mean count | 18.3 | 18.4 | ||
| Week-10, mean count | 8.9 | 12.8 | ||
| Reduction | 9.4 (50.7) | 5.6 (32.6) | ||
| Investigator Global Assessment | 557 | 189 | ||
| Subject clear or almost clear | 214 (38.42) | 52 (27.51) | ||
| Subject with no change | 159 (28.5) | 77 (40.7) | ||
Subjects treated with metronidazole gel USP, 1% experienced a mean reduction of 9.4 inflammatory lesions in the Week-10 LOCF group, compared to a reduction of 5.6 for those treated with vehicle, or a difference in means of 3.8 lesions.
The contribution to efficacy of individual components of the vehicle has not been established.
16 HOW SUPPLIED
16.1 How Supplied
Metronidazole Gel USP, 1% is clear, colorless to pale yellow in color, and supplied as follows:
60 gram tube – NDC 0781-7080-35
55 gram pump – NDC 0781-7080-55
16.2 Storage and Handling
Storage Conditions: Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].
17 PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (Patient Information).
Administration Instructions
Use as directed. Avoid contact with the eyes.
Cleanse treated areas before the application of metronidazole gel USP, 1%
Advise patients to report any adverse reaction to their healthcare providers.
Lactation
Advise women not to breastfeed during treatment with metronidazole gel USP, 1% [see Use in Specific Populations (8.2)].
Rx Only
Manufactured by
Tolmar, Inc.
Fort Collins, CO 80526 for
Sandoz Inc.
Princeton, NJ 08540
44445 Rev. 2 04/22
PATIENT INFORMATION
PATIENT INFORMATION Metronidazole Gel USP, 1% (me troe ni’ da zole) |
Important: Metronidazole gel USP, 1% is for use on the skin only (topical use). Do not use metronidazole gel USP, 1% in your mouth, eyes, or vagina. |
What is metronidazole gel USP, 1%? Metronidazole gel USP, 1% is a prescription medicine used on the skin (topical) to treat pimples and bumps (inflammatory lesions) caused by a condition called rosacea. It is not known if metronidazole gel USP, 1% is safe and effective in children. |
Do not use metronidazole gel USP, 1% if you are allergic to metronidazole or any of the ingredients in metronidazole gel USP, 1%. See the end of this leaflet for a complete list of ingredients in metronidazole gel USP, 1%. |
Before using metronidazole gel USP, 1%, tell your healthcare provider about all your medical conditions, including if you:
Tell your healthcare provider about all of the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine. |
How should I use metronidazole gel USP, 1%?
|
What are the possible side effects of metronidazole gel USP, 1%?
Tell your healthcare provider if you get any side effects during treatment with metronidazole gel USP, 1%. These are not all of the possible side effects of metronidazole gel USP, 1%. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects to Sandoz Inc. at 1-800-525-8747. |
How should I store metronidazole gel USP, 1%?
Keep metronidazole gel USP, 1% and all medicines out of the reach of children. |
General information about the safe and effective use of metronidazole gel USP, 1%. Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use metronidazole gel USP, 1% for a condition for which it was not prescribed. Do not give metronidazole gel USP, 1% to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about metronidazole gel USP, 1% that is written for health professionals. |
What are the ingredients in metronidazole gel USP, 1%? Active ingredient: metronidazole Inactive ingredients: betadex, edetate disodium, hydroxyethyl cellulose, methylparaben, niacinamide, phenoxyethanol, propylene glycol, propylparaben and purified water Manufactured by Tolmar, Inc. Fort Collins, CO 80526 for Sandoz Inc. Princeton, NJ 08540 For more information, call 1-866-735-4137. |
This Patient Information has been approved by the U.S. Food and Drug Administration. Issued: 04/2022
44445 Rev. 2 04/22
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0781-7080-35 | GM - Gram | 0781-7080 | 49b88f51-3aa2-46f0-91a9-876f54c45e9f | 1 | 2013-08-02 |
| 0781-7080-55 | GM - Gram | 0781-7080 | 896e7254-7681-494c-99b4-015d8b40b1ee | 1 | 2013-08-02 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| METRONIDAZOLE | ACTIVE INGREDIENT | 140QMO216E | 5 | |
| METRONIDAZOLE | ACTIVE MOIETY | 140QMO216E | 5 | |
| CETETH-20 | INACTIVE INGREDIENT | I835H2IHHX | 5 | |
| EDETATE DISODIUM | INACTIVE INGREDIENT | 7FLD91C86K | 5 | |
| HYDROXYETHYL CELLULOSE (4000 CPS AT 1%) | INACTIVE INGREDIENT | ZYD53NBL45 | 5 | |
| METHYLPARABEN | INACTIVE INGREDIENT | A2I8C7HI9T | 5 | |
| NIACINAMIDE | INACTIVE INGREDIENT | 25X51I8RD4 | 5 | |
| PHENOXYETHANOL | INACTIVE INGREDIENT | HIE492ZZ3T | 5 | |
| PROPYLENE GLYCOL | INACTIVE INGREDIENT | 6DC9Q167V3 | 5 | |
| PROPYLPARABEN | INACTIVE INGREDIENT | Z8IX2SC1OH | 5 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | 5 |
Products#
Every source-derived product name is available through these pages.
- Metronidazole
- CETETH-20
- EDETATE DISODIUM
- HYDROXYETHYL CELLULOSE (4000 MPA.S AT 1%)
- METHYLPARABEN
- NIACINAMIDE
- PHENOXYETHANOL
- PROPYLENE GLYCOL
- PROPYLPARABEN
- WATER
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 0781-7080 | 0781-7080-35, 0781-7080-55 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| METRONIDAZOLE | 140QMO216E | ACTIB |
| CETETH-20 | I835H2IHHX | IACT |
| EDETATE DISODIUM | 7FLD91C86K | IACT |
| HYDROXYETHYL CELLULOSE (4000 MPA.S AT 1%) | ZYD53NBL45 | IACT |
| METHYLPARABEN | A2I8C7HI9T | IACT |
| NIACINAMIDE | 25X51I8RD4 | IACT |
| PHENOXYETHANOL | HIE492ZZ3T | IACT |
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
| PROPYLPARABEN | Z8IX2SC1OH | IACT |
| WATER | 059QF0KO0R | IACT |
Source Document#
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.
| DailyMed ingredient | IID ingredient | UNII | Dosage form / route | Potency | Maximum daily exposure | Match |
|---|---|---|---|---|---|---|
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | SUSPENSION / ORAL | 64 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | AEROSOL, FOAM / VAGINAL | 6.4 %w/w | ||
| PHENOXYETHANOL | PHENOXYETHANOL | HIE492ZZ3T | GEL / TOPICAL | 14 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SPONGE / TOPICAL | 40 %w/w | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | CREAM, AUGMENTED / TOPICAL | 2 mg | ||
| HYDROXYETHYL CELLULOSE (4000 CPS AT 1%) | HYDROXYETHYL CELLULOSE (4000 MPA.S AT 1%) | ZYD53NBL45 | GEL / TOPICAL | 231 mg | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | ELIXIR / ORAL | 1.3 mg/5ml | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | INJECTION / EPIDURAL | 1 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | INJECTION / PARENTERAL | 2 mg | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | SOLUTION / NASAL | 100 mg/100ml | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | SOLUTION / INTRAVENOUS | 0.13 %w/v | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | EMULSION / OPHTHALMIC | 1.5 %w/v | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | INJECTION / INTRALESIONAL | 0.02 %w/v | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | SHAMPOO, SUSPENSION / TOPICAL | 1 %w/w | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | INJECTION, SUSPENSION / INTRAMUSCULAR | 0.02 %w/v | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | INJECTION, SOLUTION / SUBCUTANEOUS | 1.4 %w/v | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | GEL / TOPICAL | 4522 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SUPPOSITORY / VAGINAL | 252 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | SOLUTION, CONCENTRATE / ORAL | 0.2 mg/1ml | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SOLUTION / TOPICAL | 4886 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | INJECTION / INTRALESIONAL | 0.15 %w/v | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | OINTMENT / TOPICAL | 29 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | TABLET, FILM COATED / ORAL | 96 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | FILM / BUCCAL | 1.48 mg | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | TABLET, ORALLY DISINTEGRATING / ORAL | 3 mg | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | DROPS / OPHTHALMIC | 0.05 %w/v | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | LOTION / TOPICAL | 140 mg | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | EMULSION / OPHTHALMIC | 0.3 %w/v | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | INJECTION / SUBCUTANEOUS | 1.4 %w/v | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | SOLUTION, CONCENTRATE / ORAL | 1 mg/1ml | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | INJECTION / SOFT TISSUE | 0.05 %w/v | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | LIQUID / ORAL | 29008 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | LIQUID / RESPIRATORY (INHALATION) | 10 %w/w | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | OINTMENT / TOPICAL | 0.2 %w/w | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | JELLY / NASAL | 250 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | SUSPENSION / RECTAL | 1808 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | SOLUTION/ DROPS / OPHTHALMIC | 0.01 %w/v | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | SOLUTION / RESPIRATORY (INHALATION) | 0.03 %w/w | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | SOLUTION / INTRAVENOUS | 0.02 %w/v | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SUSPENSION / RECTAL | 90400 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | INJECTION, SOLUTION / PARENTERAL | 30 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | AEROSOL, FOAM / TOPICAL | 1800 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | LOTION / TOPICAL | 351 mg | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | INJECTION, SUSPENSION / SOFT TISSUE | 1 mg | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | TABLET, EXTENDED RELEASE / ORAL | 10 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | TABLET, DELAYED RELEASE / ORAL | 36 mg | ||
| HYDROXYETHYL CELLULOSE (4000 CPS AT 1%) | HYDROXYETHYL CELLULOSE (4000 MPA.S AT 1%) | ZYD53NBL45 | CAPSULE / ORAL | 2.98 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | CREAM, AUGMENTED / TOPICAL | 2 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | ENEMA / RECTAL | 0.18 %w/v | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | DROPS / NASAL | 26 mg | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | SOLUTION / ORAL | 432 mg | ||
| PHENOXYETHANOL | PHENOXYETHANOL | HIE492ZZ3T | AEROSOL / TOPICAL | 1.05 %w/w | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | FILM, SOLUBLE / BUCCAL | 1 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | CREAM / TOPICAL | 3000 mg | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | DROPS / NASAL | 0.1 mg/1ml | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | SUSPENSION/ DROPS / OPHTHALMIC | 1 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | INJECTION / INFILTRATION | 0.35 mg | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | INJECTION, SUSPENSION / INTRAMUSCULAR | 1 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | TABLET / ORAL | 64 mg | ||
| PROPYLPARABEN | PROPYLPARABEN | Z8IX2SC1OH | POWDER, FOR SOLUTION / ORAL | 13 mg |
Orange Book application contexts#
All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A090903-001 | METRONIDAZOLE | METRONIDAZOLE | 1% | GEL / TOPICAL | 2011-07-22 |
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.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A090903-001 | METRONIDAZOLE | 1% | GEL / TOPICAL | 2011-07-22 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A090903-001 | METRONIDAZOLE | 1% | GEL / TOPICAL | 2011-07-22 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A090903-001 | METRONIDAZOLE | 1% | GEL / TOPICAL | 2011-07-22 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090903-001 | METRONIDAZOLE | 1% | GEL / TOPICAL | 2011-07-22 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A090903-001 | METRONIDAZOLE | 1% | GEL / TOPICAL | 2011-07-22 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090903-001 | METRONIDAZOLE | 1% | GEL / TOPICAL | 2011-07-22 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090903-001 | METRONIDAZOLE | 1% | GEL / TOPICAL | 2011-07-22 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090903-001 | METRONIDAZOLE | 1% | GEL / TOPICAL | 2011-07-22 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A090903-001 | METRONIDAZOLE | 1% | GEL / TOPICAL | 2011-07-22 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A090903-001 | METRONIDAZOLE | 1% | GEL / TOPICAL | 2011-07-22 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A090903-001 | METRONIDAZOLE | 1% | GEL / TOPICAL | 2011-07-22 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A090903-001 | METRONIDAZOLE | 1% | GEL / TOPICAL | 2011-07-22 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A090903-001 | METRONIDAZOLE | 1% | GEL / TOPICAL | 2011-07-22 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A090903-001 | METRONIDAZOLE | 1% | GEL / TOPICAL | 2011-07-22 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A090903-001 | METRONIDAZOLE | 1% | GEL / TOPICAL | 2011-07-22 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A090903-001 | METRONIDAZOLE | 1% | GEL / TOPICAL | 2011-07-22 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A090903-001 | METRONIDAZOLE | 1% | GEL / TOPICAL | AB | 2011-07-22 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | A090903-001 | METRONIDAZOLE | 1% | GEL / TOPICAL | AB | 2011-07-22 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A090903-001 | METRONIDAZOLE | 1% | GEL / TOPICAL | AB | 2011-07-22 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | A090903-001 | METRONIDAZOLE | 1% | GEL / TOPICAL | AB | 2011-07-22 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | A090903-001 | METRONIDAZOLE | 1% | GEL / TOPICAL | AB | 2011-07-22 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | A090903-001 | METRONIDAZOLE | 1% | GEL / TOPICAL | AB | 2011-07-22 | 782e0a99824c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A090903-001 | METRONIDAZOLE | 1% | GEL / TOPICAL | AB | 2011-07-22 | 87673890dc5c… | |
| 2021-03-12 10:30 UTC | 2021-03 | A090903-001 | METRONIDAZOLE | 1% | GEL / TOPICAL | AB | 2011-07-22 | 5aa47cf7b7d7… | |
| 2020-12-22 03:56 UTC | 2020-12 | A090903-001 | METRONIDAZOLE | 1% | GEL / TOPICAL | AB | 2011-07-22 | 8869cabd3fbd… | |
| 2020-11-12 02:37 UTC | 2020-11 | A090903-001 | METRONIDAZOLE | 1% | GEL / TOPICAL | AB | 2011-07-22 | c0c555d07b60… | |
| 2019-12-14 00:12 UTC | 2019-12 | A090903-001 | METRONIDAZOLE | 1% | GEL / TOPICAL | AB | 2011-07-22 | 3f01610625f2… | |
| 2019-09-15 20:21 UTC | 2019-09 | A090903-001 | METRONIDAZOLE | 1% | GEL / TOPICAL | AB | 2011-07-22 | b00525d2431f… | |
| 2019-07-19 19:46 UTC | 2019-07 | A090903-001 | METRONIDAZOLE | 1% | GEL / TOPICAL | AB | 2011-07-22 | ea99ee380514… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A090903-001 | METRONIDAZOLE | 1% | GEL / TOPICAL | 2011-07-22 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A090903-001 | METRONIDAZOLE | 1% | GEL / TOPICAL | 2011-07-22 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A090903-001 | METRONIDAZOLE | 1% | GEL / TOPICAL | 2011-07-22 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A090903-001 | METRONIDAZOLE | 1% | GEL / TOPICAL | 2011-07-22 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A090903-001 | METRONIDAZOLE | 1% | GEL / TOPICAL | 2011-07-22 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A090903-001 | METRONIDAZOLE | 1% | GEL / TOPICAL | 2011-07-22 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A090903-001 | METRONIDAZOLE | 1% | GEL / TOPICAL | 2011-07-22 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A090903-001 | METRONIDAZOLE | 1% | GEL / TOPICAL | 2011-07-22 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A090903-001 | METRONIDAZOLE | 1% | GEL / TOPICAL | AB | 2011-07-22 | 3bdfa0b2c4d7… | |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A090903-001 | METRONIDAZOLE | 1% | GEL / TOPICAL | AB | 2011-07-22 | 3a93d1ddd44b… | |
| 2022-10-28 04:53 UTC | 2022-10 | A090903-001 | METRONIDAZOLE | 1% | GEL / TOPICAL | AB | 2011-07-22 | f41ea6bd6efb… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A090903-001 | AB | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A090903-001 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A090903-001 | AB | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A090903-001 | AB | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A090903-001 | AB | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A090903-001 | AB | 1 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A090903-001 | AB | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | A090903-001 | AB | 1 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | A090903-001 | AB | 1 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | A090903-001 | AB | 1 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | A090903-001 | AB | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | A090903-001 | AB | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | A090903-001 | AB | 1 | ea99ee380514… |
| 2023-01-26 05:58 UTC | 2023-01 | A090903-001 | AB | 1 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A090903-001 | AB | 1 | 3a93d1ddd44b… |
| 2022-10-28 04:53 UTC | 2022-10 | A090903-001 | AB | 1 | f41ea6bd6efb… |
| 2022-09-29 23:25 UTC | 2022-09 | A090903-001 | AB | 1 | e64feba35796… |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A090903-001 | AB | 1 | cb3db0bc1861… |
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| eb45b63f-68e3-4d4e-87e1-1a1e5d512640 | caaf1b7f-eaab-4fb6-a955-b7d881038fef | 2022-04-01 | Warnings, Adverse reactions | eb45b63f-68e3-4d4e-87e1-1a1e5d512640 caaf1b7f-eaab-4fb6-a955-b7d881038fef |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.