Fluorouracil 50 mg/g Cream
🆔 Identity & classification
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🏷️ RxNorm drug class
This medicine belongs to the Nucleoside Metabolic Inhibitor class.
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🏭 Manufacturer & labeler
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🩺 Clinical
Fluorouracil cream and topical solution are used to treat actinic or solar keratoses (scaly or crusted lesions [skin areas] caused by years of too much exposure to sunlight). Fluorouracil cream and topical solution are also used to treat a type of skin cancer called superficial basal cell carcinoma if usual types of treatment cannot be used. Fluorouracil is in a class of medications called antimetabolites. It works by killing fast-growing cells such as the abnormal cells in actinic keratoses and basal cell carcinoma.
Read the full MedlinePlus article ↗- Yes, it is actually expected and means the medication is working. When you apply fluorouracil topically to treat actinic keratoses or superficial skin cancer, the treated area typi...
- Why does my skin look so bad while using the cream — is that supposed to happen?
- DPD (dihydropyrimidine dehydrogenase) is the enzyme your body uses to break down most of the fluorouracil you receive. If you're missing this enzyme — either partially or completel...
- What is the DPD deficiency test, and do I really need it before starting?
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Fluorouracil — tap one for details:
Fluorouracil may be associated with lower levels of 2 nutrients — worth a chat with your pharmacist, not a cause for alarm.
Where does this data come from?
Ask a licensed pharmacist directly — free, answered by our team.
💊 What it looks like
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🧪 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.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
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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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A synthetic emulsifier derived from sorbitol and fatty acids. It helps mix oil and water-based ingredients together and improves the texture and stability of the medicine.
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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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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.
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UNII 2KR89I4H1Y
Stearyl alcohol is a waxy, fatty substance derived from natural oils or made synthetically. It acts as an emulsifier and thickener in medicines, helping mix ingredients together and give the product the right texture.
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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.
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White petrolatum is a purified mineral oil product used as a lubricant and skin protectant in medications. It helps pills slide through manufacturing equipment and can soften or protect the skin when applied topically.
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.Inactive ingredient FAQ
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💲 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 | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data. | |
| Medicare drug plans payPart D · Q2 2026 | $1.45 | $36.31 / 25 g |
Where does this data come from?
🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Fluorouracil 50 mg/g 16729-0542-35 | Accord | 1 tube | $0.592 | AB | Availability likely | — |
| Fluorouracil 5 mg/g 00378-4791-06 | Mylan | 1 tube | $0.603 | AB | Availability likely | — |
| Fluorouracil 50 mg/g 16714-0178-01 | NORTHSTAR | 1 tube | $0.603 | AB | Availability likely | — |
| Fluorouracil 2 g/40g 21922-0049-17 | Encube | 1 tube | $0.603 | AB | Availability likely | — |
| Fluorouracil 50 mg/g 51862-0362-40 | Mayne | 1 tube | $0.603 | AB | Availability likely | — |
| Fluorouracil 50 mg/g 75907-0095-40 | Dr. | 1 tube | $0.603 | AB | Availability likely | — |
| Efudex 2 g/40g 00187-3204-47 | Bausch | 1 tube | $1.438 | AB | FDA listed | — |
| Fluorouracil 50 mg/gthis 51672-4118-02 | Sun | 1 tube | — | AB | FDA listed | — |
Where does this data come from?
⏳ 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?
💊 Medicaid utilization by pack size
📊 Medicare Part D spend CMS · PART D · 2026 (Q1)
🔬 Reported adverse events (FAERS)
Top reported reactions
Age at onset
Reporter sex
Serious outcomes
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📦 Packaging — all sizes for this product
| Package NDC | Description | Per unit | Per pack | Marketing start | Status |
|---|---|---|---|---|---|
| 51672-4118-02 You're viewing this | 1 TUBE in 1 CARTON (51672-4118-2) / 25 g in 1 TUBE | — | — | 2017-03-17 | Active |
| 51672-4118-05 | 5 g in 1 TUBE (51672-4118-5) | — | — | 2017-03-17 | Active |
| 51672-4118-06 | 1 TUBE in 1 CARTON (51672-4118-6) / 40 g in 1 TUBE | $0.6034 / g | $24.14 | 2017-03-17 | Active |
This pack shows little to no recent Medicaid volume — a different pack size carries most fills. See all packs ↓
Pack size FAQ
What quantity is in NDC 51672-4118-02?
What NDC number is used to bill for this package of Fluorouracil 50 mg/g Cream?
Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.
🧭 About this NDC listing & data coverage
What data is (and isn’t) available for this NDC — tap to expand
| NDC identity (package / product / labeler codes) | ✓ Available |
| Labeler | ✓ Available |
| Product & package description | ✓ Available |
| Marketing category & status | ✓ Available |
| Active ingredient / dosage form / route | ✓ Available |
| FDA label (SPL via DailyMed) | ✓ Available |
| Package photos | ✓ Available |
| Inactive ingredients (structured) | ✓ Available |
| NADAC pharmacy acquisition price (CMS) | — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey. |
| Orange Book / therapeutic-equivalence data | ✓ Available |
| HCPCS J-code billing crosswalk | — Not published for this NDC Most self-administered / retail products have no J-code — that is normal. |
| Medicaid utilization (CMS SDUD) | — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold. |
Questions about this listing
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📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
INDICATIONS AND USAGE Fluorouracil is recommended for the topical treatment of multiple actinic or solar keratoses. In the 5% strength, it is also useful in the treatment of superficial basal cell carcinomas when conventional methods are impractical, such as with multiple lesions or difficult treatment sites. Safety and efficacy in other indications have not been established.
The diagnosis should be established prior to treatment, since this method has not been proven effective in other types of basal cell carcinomas. With isolated, easily accessible basal cell carcinomas, surgery is preferred since success with such lesions is almost 100%. The success rate with fluorouracil cream and solution is approximately 93%, based on 113 lesions in 54 patients.
Twenty-five lesions treated with the solution produced 1 failure and 88 lesions treated with the cream produced 7 failures.
⏱️ Dosage and Administration ▾
DOSAGE AND ADMINISTRATION When fluorouracil is applied to a lesion, a response occurs with the following sequence: erythema, usually followed by vesiculation, desquamation, erosion and re-epithelialization. Fluorouracil should be applied preferably with a nonmetal applicator or suitable glove. If fluorouracil is applied with the fingers, the hands should be washed immediately afterward.
Actinic or Solar Keratosis Apply cream twice daily in an amount sufficient to cover the lesions. Medication should be continued until the inflammatory response reaches the erosion stage, at which time use of the drug should be terminated. The usual duration of therapy is from 2 to 4 weeks.
Complete healing of the lesions may not be evident for 1 to 2 months following cessation of fluorouracil therapy. Superficial Basal Cell Carcinomas Only the 5% strength is recommended. Apply cream twice daily in an amount sufficient to cover the lesions.
Treatment should be continued for at least 3 to 6 weeks. Therapy may be required for as long as 10 to 12 weeks before the lesions are obliterated. As in any neoplastic condition, the patient should be followed for a reasonable period of time to determine if a cure has been obtained.
⛔ Contraindications ▾
CONTRAINDICATIONS Fluorouracil may cause fetal harm when administered to a pregnant woman. There are no adequate and well-controlled studies in pregnant women with either the topical or the parenteral forms of fluorouracil. One birth defect (cleft lip and palate) has been reported in the newborn of a patient using fluorouracil as recommended.
One birth defect (ventricular septal defect) and cases of miscarriage have been reported when fluorouracil was applied to mucous membrane areas. Multiple birth defects have been reported in a fetus of a patient treated with intravenous fluorouracil. Animal reproduction studies have not been conducted with fluorouracil.
Fluorouracil administered parenterally has been shown to be teratogenic in mice, rats, and hamsters when given at doses equivalent to the usual human intravenous dose; however, the amount of fluorouracil absorbed systemically after topical administration to actinic keratoses is minimal (see CLINICAL PHARMACOLOGY ). Fluorouracil exhibited maximum teratogenicity when given to mice as single intraperitoneal injections of 10 to 40 mg/kg on Day 10 or 12 of gestation. Similarly, intraperitoneal doses of 12 to 37 mg/kg given to rats between Days 9 and 12 of gestation and intramuscular doses of 3 to 9 mg/kg given to hamsters between Days 8 and 11 of gestation were teratogenic and/or embryotoxic (i.e., resulted in increased resorptions or embryolethality).
In monkeys, divided doses of 40 mg/kg given between Days 20 and 24 of gestation were not teratogenic. Doses higher than 40 mg/kg resulted in abortion. Fluorouracil should not be used in patients with dihydropyrimidine dehydrogenase (DPD) enzyme deficiency.
A large percentage of fluorouracil is catabolized by the DPD enzyme. DPD enzyme deficiency can result in shunting of fluorouracil to the anabolic pathway, leading to cytotoxic activity and potential toxicities. Fluorouracil is contraindicated in women who are or may become pregnant during therapy.
If this drug is used during pregnancy, or if the patient becomes pregnant while using this drug, the patient should be apprised of the potential hazard to the fetus. Fluorouracil is also contraindicated in patients with known hypersensitivity to any of its components.
⚠️ Warnings ▾
WARNINGS Application to mucous membranes should be avoided due to the possibility of local inflammation and ulceration. Additionally, cases of miscarriage and a birth defect (ventricular septal defect) have been reported when fluorouracil was applied to mucous membrane areas during pregnancy. Occlusion of the skin with resultant hydration has been shown to increase percutaneous penetration of several topical preparations.
If any occlusive dressing is used in treatment of basal cell carcinoma, there may be an increase in the severity of inflammatory reactions in the adjacent normal skin. A porous gauze dressing may be applied for cosmetic reasons without increase in reaction. Exposure to ultraviolet rays should be minimized during and immediately following treatment with fluorouracil because the intensity of the reaction may be increased.
Patients should discontinue therapy with fluorouracil if symptoms of DPD enzyme deficiency develop (see CONTRAINDICATIONS section). Rarely, life-threatening toxicities such as stomatitis, diarrhea, neutropenia, and neurotoxicity have been reported with intravenous administration of fluorouracil in patients with DPD enzyme deficiency. One case of life-threatening systemic toxicity has been reported with the topical use of fluorouracil in a patient with DPD enzyme deficiency.
Symptoms included severe abdominal pain, bloody diarrhea, vomiting, fever, and chills. Physical examination revealed stomatitis, erythematous skin rash, neutropenia, thrombocytopenia, inflammation of the esophagus, stomach, and small bowel. Although this case was observed with 5% fluorouracil cream, it is unknown whether patients with profound DPD enzyme deficiency would develop systemic toxicity with lower concentrations of topically applied fluorouracil.
🤒 Adverse Reactions ▾
ADVERSE REACTIONS The most frequent adverse reactions to fluorouracil occur locally and are often related to an extension of the pharmacological activity of the drug. These include burning, crusting, allergic contact dermatitis, pruritus, scarring, rash, soreness and ulceration. Ulcerations, other local reactions, cases of miscarriage and a birth defect (ventricular septal defect) have been reported when fluorouracil was applied to mucous membrane areas.
Leukocytosis is the most frequent hematological side effect. Although a causal relationship is remote, other adverse reactions which have been reported infrequently are: Central Nervous System: Emotional upset, insomnia, irritability. Gastrointestinal: Medicinal taste, stomatitis.
Hematological: Eosinophilia, thrombocytopenia, toxic granulation. Integumentary: Alopecia, blistering, bullous pemphigoid, discomfort, ichthyosis, scaling, suppuration, swelling, telangiectasia, tenderness, urticaria, skin rash. Special Senses: Conjunctival reaction, corneal reaction, lacrimation, nasal irritation.
Miscellaneous: Herpes simplex. To report SUSPECTED ADVERSE REACTIONS, contact Taro Pharmaceuticals U.S.A., Inc., at 1-866-923-4914 and/or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
🤰 Pregnancy ▾
Pregnancy See CONTRAINDICATIONS .
🧒 Pediatric Use ▾
Pediatric Use Safety and effectiveness in children have not been established.
🆘 Overdosage ▾
OVERDOSAGE There have been no reports of overdosage with fluorouracil. The oral LD 50 for the 5% cream was 234 mg/kg in rats and 39 mg/kg in dogs. These doses represented 11.7 and 1.95 mg/kg of fluorouracil, respectively.
Studies with a 5% topical solution yielded an oral LD 50 of 214 mg/kg in rats and 28.5 mg/kg in dogs, corresponding to 10.7 and 1.43 mg/kg of fluorouracil, respectively. The topical application of the 5% cream to rats yielded an LD 50 of greater than 500 mg/kg.
🧬 Clinical Pharmacology ▾
CLINICAL PHARMACOLOGY There is evidence that the metabolism of fluorouracil in the anabolic pathway blocks the methylation reaction of deoxyuridylic acid to thymidylic acid. In this manner fluorouracil interferes with the synthesis of deoxyribonucleic acid (DNA) and to a lesser extent inhibits the formation of ribonucleic acid (RNA). Since DNA and RNA are essential for cell division and growth, the effect of fluorouracil may be to create a thymine deficiency which provokes unbalanced growth and death of the cell.
The effects of DNA and RNA deprivation are most marked on those cells which grow more rapidly and take up fluorouracil at a more rapid rate. The catabolic metabolism of fluorouracil results in degradation products (e.g., CO 2 , urea, α-fluoro-β-alanine) which are inactive. Systemic absorption studies of topically applied fluorouracil have been performed on patients with actinic keratoses using tracer amounts of 14 C-labeled fluorouracil added to a 5% preparation.
All patients had been receiving nonlabeled fluorouracil until the peak of the inflammatory reaction occurred (2 to 3 weeks), ensuring that the time of maximum absorption was used for measurement. One gram of labeled preparation was applied to the entire face and neck and left in place for 12 hours. Urine samples were collected.
At the end of 3 days, the total recovery ranged between 0.48% and 0.94% with an average of 0.76%, indicating that approximately 5.98% of the topical dose was absorbed systemically. If applied twice daily, this would indicate systemic absorption of topical fluorouracil to be in the range of 5 to 6 mg per daily dose of 100 mg. In an additional study, negligible amounts of labeled material were found in plasma, urine and expired CO 2 after 3 days of treatment with topically applied 14 C-labeled fluorouracil.
📦 How Supplied / Storage and Handling ▾
HOW SUPPLIED Fluorouracil Cream USP, 5% is supplied in a 25 g tube (NDC 51672-4118-2) and 40 g tube (NDC 51672-4118-6). Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
📦 Storage and Handling ▾
Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
📋 Description ▾
DESCRIPTION Fluorouracil Cream is a topical preparation containing the fluorinated pyrimidine 5-fluorouracil, an antineoplastic antimetabolite. Fluorouracil Cream contains 5% w/w of fluorouracil USP in a cream base consisting of methylparaben, polysorbate 60, propylene glycol, propylparaben, purified water, stearyl alcohol and white petrolatum. Chemically, fluorouracil is 5-fluoro-2,4(1 H ,3 H )-pyrimidinedione.
It is a white to practically white crystalline powder which is sparingly soluble in water and slightly soluble in alcohol. One gram of fluorouracil is soluble in 100 mL of propylene glycol. The molecular weight of 5-fluorouracil is 130.08 and the structural formula is: Chemical Structure
💬 Information for Patients ▾
Information for Patients Patients should be forewarned that the reaction in the treated areas may be unsightly during therapy and, usually, for several weeks following cessation of therapy. Patients should be instructed to avoid exposure to ultraviolet rays during and immediately following treatment with fluorouracil because the intensity of the reaction may be increased. If fluorouracil is applied with the fingers, the hands should be washed immediately afterward.
Fluorouracil should not be applied on the eyelids or directly into the eyes, nose or mouth because irritation may occur. Fluorouracil, including fluorouracil cream, may be fatal if ingested by pets. Avoid allowing pets to contact the fluorouracil cream container or the skin where fluorouracil cream has been applied.
Store fluorouracil cream out of reach of pets. Safely discard or clean any cloth or applicator that may retain fluorouracil cream and avoid leaving any residues of fluorouracil cream on your hands, clothing, carpeting or furniture.