Metronidazole 7.5 mg/g Gel — NDC 0713-0637-37 (Billing 00713-0637-37)
This is a package of Metronidazole 7.5 mg/g Gel from Cosette Pharmaceuticals, Inc., marketed since Apr 2011 and currently FDA-listed; retail pharmacies pay about $0.1793 per g (NADAC). It is this product's only package size.
NDC database record
One package, one record: these facts belong to NDC 0713-0637-37 alone.
- Record
- FDA NDC Directory package listing · Human prescription drug
- Code segments
- 0713 labeler · 0637 product · 37 package
- Package marketed since
- Apr 1, 2011
- Sample package
- No — commercial package
- Listing certified through
- Dec 31, 2026
- Barcode (UPC)
- 0307130637374
- Medicaid fills, this package
- 24,564 prescriptions in the last four reported quarters
- FDA record last changed
- Jul 24, 2026
Identity & classification
Regulatory identifiers FDA, NLM and CMS codes for this package
Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification
- GSN (GCN sequence number): 041798
- GCN: 43202
- GPI-14 (Medi-Span): 90060040004010
- HICL (First Databank): 004157
- AHFS class code: 08:30.04.00
- RxCUI (RxNorm): 311679
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 5, 2026
- RxNorm (NLM RxNav) · catalog refreshed Oct 1, 2026
- Medi-Span GPI (licensed)
- First Databank (licensed) · refreshed Oct 1, 2026
RxNorm drug class
This medicine belongs to the Nitroimidazole Antimicrobial class.
Where does this data come from?
- RxClass (NLM) · catalog refreshed Oct 1, 2026
Clinical
Metronidazole topical is used to treat rosacea (a skin disease that causes redness, flushing, and pimples on the face). Metronidazole is in a class of medications called nitroimidazole antimicrobials. It works by stopping the growth of bacteria.
Read the full MedlinePlus article ↗- It depends on the product. Oral forms treat trichomoniasis, and some also treat amebiasis and anaerobic infections. Vaginal gels treat bacterial vaginosis, and topical cream or lot...
- No. Alcohol with oral metronidazole can cause cramps, nausea, vomiting, headache and flushing. Avoid alcohol and products with propylene glycol during treatment and for at least th...
- The most common are nausea, headache, loss of appetite, vomiting, diarrhea and stomach cramps. A metallic taste is also common. Call your doctor if you notice numbness or tingling,...
- Yes. Metronidazole can interact with warfarin, lithium, busulfan, disulfiram and drugs that affect heart rhythm. Some of these combinations need blood tests or should be avoided, s...
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Metronidazole — tap one for details:
Metronidazole may be associated with lower levels of 7 nutrients — worth a chat with your pharmacist, not a cause for alarm.
Where does this data come from?
- MedlinePlus (NLM) · refreshed Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 5, 2026
Ask a licensed pharmacist directly — free, answered by our team.
Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per g | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $0.179 | $8.07 / 45 g |
| Medicaid paysCMS SDUD · 12 mo | $0.6262 | $28.18 / 45 g |
| Medicare drug plans payPart D · Q2 2026 | $0.7576 | $34.09 / 45 g |
Where does this data come from?
- CMS NADAC weekly file · file of Sep 30, 2026
- CMS ASP pricing files · refreshed Sep 20, 2026
- CMS Medicaid State Drug Utilization Data · through Q1 2026
- CMS Part D plan pricing files · refreshed Sep 24, 2026
- VA National Acquisition Center price file
Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Marketing end | Status |
|---|---|---|---|---|
| 00713-0637-37 You're viewing this Main listing | 1 TUBE in 1 CARTON / 45 g in 1 TUBE | 2011-04-01 | — | Active |
Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Metronidazole 7.5 mg/gthis 00713-0637-37 | Cosette | 1 tube | $0.179 | AB | Availability likely | — |
| Metronidazole 7.5 mg/g 21922-0070-06 | Encube | 1 tube | $0.179 | AB | Availability likely | — |
| Metronidazole 7.5 mg/g 72578-0209-04 | Viona | 1 tube | $0.179 | AB | Availability likely | — |
| Metronidazole 7.5 mg/g 00713-0633-37 | Cosette | 1 tube | $0.257 | AB | Availability likely | +43% |
| Metronidazole 7.5 mg/g 68308-0711-45 | Mayne | 1 tube | $0.257 | AB | Availability likely | +43% |
| Metronidazole 7.5 mg/g 00168-0323-46 | Fougera | 45 g | $0.257 | AB | Availability likely | +43% |
| Metronidazole 7.5 mg/g 59651-0770-46 | Aurobindo | 1 tube | $0.257 | AB | Availability likely | +43% |
| Metronidazole 7.5 mg/g 66993-0960-45 | Prasco | 1 tube | $0.257 | AB | Availability likely | +43% |
| Metronidazole 7.5 mg/g 72578-0129-08 | Viona | 1 tube | $0.257 | BX | Availability likely | +43% |
| metronidazole 7.5 mg/g 68308-0712-59 | Mayne | 1 bottle | $1.817 | AB | Availability likely | +914% |
| Metronidazole 7.5 mg/g 51672-4116-02 | Sun | 1 tube | — | AB | FDA listed | — |
| Metronidazole 7.5 mg/g 67296-2121-04 | Redpharm | 1 tube | — | AB | FDA listed | — |
| Metronidazole 7.5 mg/g 70771-1978-04 | Zydus | 1 tube | — | AB | FDA listed | — |
| Metronidazole 7.5 mg/g 70771-1834-04 | Zydus | 1 tube | — | BX | FDA listed | — |
| Metronidazole 7.5 mg/g 68788-8552-04 | Preferred | 1 tube | — | BX | FDA listed | — |
| Metronidazole 7.5 mg/g 72162-2259-02 | Bryant | 45 g | — | AB | FDA listed | — |
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA Orange Book · refreshed Oct 3, 2026
- CMS NADAC weekly file · file of Sep 30, 2026
Availability & generic status
This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.
Where does this data come from?
- FDA Orange Book · refreshed Oct 3, 2026
Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
🧪 Avoiding an ingredient? See Metronidazole inactive ingredients by manufacturer: every current product's list side by side, so you can ask your pharmacy for the version that does not list it.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
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UNII 4Q93RCW27E
A synthetic polymer made from acrylic acid that's crosslinked for stability. It acts as a thickener and gelling agent in creams and gels, helping the medicine spread evenly and maintain its texture.
-
UNII 7FLD91C86K
Edetate disodium is a chemical compound that binds and removes certain metal ions. In medicines, it acts as a preservative and stabilizer by preventing metals like calcium from interfering with the product's shelf life and consistency.
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UNII A2I8C7HI9T
Methylparaben is a preservative derived from benzoic acid that prevents growth of bacteria, fungi, and mold in medicines. It extends the product's shelf life and maintains safety during storage.
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UNII 6DC9Q167V3
Propylene glycol is a clear liquid derived from petroleum or vegetable sources. It acts as a solvent, humectant, and preservative in medicines, helping dissolve active ingredients and maintain product stability.
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UNII Z8IX2SC1OH
Propylparaben is a chemical preservative used to prevent bacterial and fungal growth in medicines and personal care products. It helps extend shelf life and maintain product safety during storage.
-
UNII 55X04QC32I
A strong alkaline chemical used to adjust and maintain the pH balance of liquid medicines. It helps keep the medicine stable and ensures it stays effective during storage.
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UNII 059QF0KO0R
Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.
7 inactive ingredients listed in the exact product block matched to this NDC.
Where does this data come from?
ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.- FDA label on DailyMed · label index refreshed Oct 5, 2026
- FDA openFDA NDC Directory · synced Oct 1, 2026
Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
Why might an inactive ingredient be missing?
Can inactive ingredients matter?
Manufacturer & labeler
More NDCs from Cosette Pharmaceuticals, Inc. labeler code 00713
- Triple Antibiotic Plus Polymyxin B Sulfate, Bacitracin Zinc, Neomycin Sulfate, Pramoxine HCl 10000 [USP'U]/g; 500 [USP'U]/g; 3.5 mg/g; 10 mg/g Ointment NDC 0713-0622-31
- Fluticasone Propionate .5 mg/g Cream NDC 0713-0631-15
- Fluticasone Propionate .05 mg/g Ointment NDC 0713-0632-15
- Metronidazole 7.5 mg/g Cream NDC 0713-0633-37
- Mometasone Furoate 1 mg/g Cream NDC 0713-0634-15
- Mometasone Furoate 1 mg/g Ointment NDC 0713-0635-15
- Ciclopirox Olamine 7.7 mg/g Cream NDC 0713-0638-15
- Halobetasol Propionate .5 mg/g Cream NDC 0713-0640-15
- Triamcinolone Acetonide 1 mg/g Paste NDC 0713-0655-40
- Clobetasol Propionate .5 mg/g Ointment NDC 0713-0656-15
- Betamethasone Dipropionate .5 mg/g Cream NDC 0713-0659-15
- Desonide .5 mg/g Cream NDC 0713-0661-15
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- Drugs@FDA
Full prescribing information FDA SPL
🎯 Indications and Usage ▾
INDICATIONS AND USAGE: Metronidazole Gel USP is indicated for topical application in the treatment of inflammatory papules and pustules of rosacea.
⏱️ Dosage and Administration ▾
DOSAGE AND ADMINISTRATION: Apply and rub in a thin film of Metronidazole Gel twice daily, morning and evening, to entire affected areas after washing. Areas to be treated should be cleansed before application of Metronidazole Gel. Patients may use cosmetics after application of Metronidazole Gel.
⛔ Contraindications ▾
CONTRAINDICATIONS: Metronidazole Gel is contraindicated in individuals with a history of hypersensitivity to metronidazole, parabens, or other ingredients of the formulation.
🤒 Adverse Reactions ▾
ADVERSE REACTIONS: 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 Cosette Pharmaceuticals, Inc. at 1-800-922-1038 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
🧬 Clinical Pharmacology ▾
CLINICAL PHARMACOLOGY: Bioavailability studies on the topical administration of 1 gram of Metronidazole Gel (7.5 mg of metronidazole) to the face of 10 rosacea patients showed a maximum serum concentration of 66 nanograms per milliliter in one patient. This concentration is approximately 100 times less than concentrations afforded by a single 250 mg oral tablet. The serum metronidazole concentrations were below the detectable limits of the assay at the majority of time points in all patients.
Three of the patients had no detectable serum concentrations of metronidazole at any time point. The mean dose of gel applied during clinical studies was 600 mg which represents 4.5 mg of metronidazole per application. Therefore, under normal usage levels, the formulation affords minimal serum concentrations of metronidazole.
The mechanisms by which Metronidazole Gel acts in the treatment of rosacea are unknown, but appear to include an anti-inflammatory effect.
📦 How Supplied / Storage and Handling ▾
HOW SUPPLIED: Metronidazole Gel USP, 0.75% is supplied in a 45 g tube NDC 0713-0637-37 Storage conditions: Store at 20º-25ºC (68º-77ºF) [see USP Controlled Room Temperature]. Distributed by: Cosette Pharmaceuticals, Inc. South Plainfield, NJ 07080 8-0637BFCPLNC3 Rev. 07/2022 VC7647
📋 Description ▾
DESCRIPTION: Metronidazole Gel USP, 0.75% 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-1 H -imidazole-1-ethanol and has the following structure: Structural Formula
⚠️ Precautions ▾
PRECAUTIONS: General : Metronidazole Gel has been reported to cause tearing of the eyes. Therefore, contact with the eyes should be avoided. If a reaction suggesting local irritation occurs, patients should be directed to use the medication less frequently or discontinue use.
Metronidazole is a nitroimidazole and should be used with care in patients with evidence of, or history of blood dyscrasia. Information for patients: This medication is to be used as directed by the physician. It is for external use only.
Avoid contact with the eyes. Drug Interactions: Oral metronidazole has been reported to potentiate the anticoagulant effect of coumarin and warfarin resulting in a prolongation of prothrombin time. The effect of topical metronidazole on prothrombin time is not known.
Carcinogenesis, mutagenesis, impairment of fertility: 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 lympyhocytes have been observed in patients treated for 8 months. Pregnancy: Teratogenic effects: Pregnancy category B: 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: 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: Safety and effectiveness in pediatric patients have not been established.
📄 Package Label / Principal Display Panel ▾
PRINCIPAL DISPLAY PANEL NDC 0713-0637-37 Metronidazole Gel USP 0.75% 45 g Rx only FOR TOPICAL USE ONLY. NOT FOR OPHTHALMIC USE. Cosette Pharmaceuticals, Inc. NDC 0713-0637-37 Metronidazole Gel USP 0.75% 45 g Rx only FOR TOPICAL USE ONLY. NOT FOR OPHTHALMIC USE. Cosette Pharmaceuticals, Inc. carton tube