FLUOROPLEX (fluorouracil) 1% Topical Cream

Manufacturer: Almirall, LLC
Effective date: 2022-03-14
Label type: HUMAN PRESCRIPTION DRUG LABEL
Version: 9
Source: legacy-cache
Hydrated at: 2026-08-01 22:05:47

Label at a glance#

ProductFluoroplex

Active ingredientFLUOROURACIL

Label structure15 sections

Indications and uses

FLUOROPLEX Cream is indicated for the topical treatment of multiple actinic (solar) keratoses.

Dosage and administration

The patient should be instructed to apply sufficient medication to cover the entire face or other affected areas. Apply medication twice daily with fingertips and wash hands afterwards. A treatment period of 2-6 weeks is usually required. Increasing the frequency of application and a longer period of administration with FLUOROPLEX Cream may be required on areas other than the head and neck. When FLUOROPLEX Cream i...

Contacts and useful links#

PhoneFDA MedWatch1-800-FDA-1088

PhoneLabel contact1-866-665-2782

Label contents#

Full prescribing information#

DESCRIPTION

DESCRIPTION SECTION

FLUOROPLEX^® (fluorouracil) 1% Topical Cream is an antineoplastic/antimetabolite product for dermatological use. Fluorouracil has the empirical formula C₄H₃FN₂O₂ and a molecular weight of 130.08. It is sparingly soluble in water and slightly soluble in alcohol. The pH is approximately 8.5.

Structural Formula:

Chemical Structure

Fluorouracil

Chemical Name:
2,4(1H,3H)-Pyrimidinedione, 5-fluoro-.

FLUOROPLEX 1% Topical Cream contains:

Active Ingredient: fluorouracil 1.0%

Inactive Ingredients: benzyl alcohol, emulsifying wax, isopropyl myristate, mineral oil, purified water, and sodium hydroxide.

CLINICAL PHARMACOLOGY

CLINICAL PHARMACOLOGY SECTION

There is evidence that fluorouracil (or its metabolites) blocks the methylation reaction of deoxyuridylic acid to thymidylic acid. In this fashion, fluorouracil interferes with the synthesis of deoxyribonucleic acid (DNA) and to a lesser extent inhibits the formation of ribonucleic acid (RNA).

INDICATIONS AND USAGE

INDICATIONS & USAGE SECTION

FLUOROPLEX Cream is indicated for the topical treatment of multiple actinic (solar) keratoses.

CONTRAINDICATIONS

CONTRAINDICATIONS SECTION

Fluorouracil is contraindicated in women who are or may become pregnant.

This product should not be used by patients who are allergic to any of its components.

WARNINGS

WARNINGS SECTION

There exists the potential for a delayed hypersensitivity reaction to fluorouracil. Patch testing to prove hypersensitivity may be inconclusive¹.

If an occlusive dressing is used, there may be an increase in the incidence of inflammatory reactions in the adjacent normal skin.

The patient should avoid prolonged exposure to sunlight or other forms of ultraviolet irradiation during treatment with FLUOROPLEX Cream, as the intensity of the reaction may be increased.

PRECAUTIONS

PRECAUTIONS SECTION

GENERAL PRECAUTIONS SECTION

General: There is a possibility of increased absorption through ulcerated or inflamed skin.

INFORMATION FOR PATIENTS SECTION

Information for patients: The medication should be applied with care near the eyes, nose, and mouth. Excessive reaction in these areas may occur due to irritation from accumulation of drug. FLUOROPLEX Cream is applied with the fingers, and the hands should be washed immediately afterward. The reaction to FLUOROPLEX Cream in treated areas may be unsightly during therapy, and, in some cases, for several weeks following cessation of therapy.

Fluorouracil, including FLUOROPLEX Cream may be fatal if ingested by pets. Avoid allowing pets to contact the FLUOROPLEX Cream container or the skin where FLUOROPLEX^® Cream has been applied. Store FLUOROPLEX Cream out of reach of pets. Safely discard or clean any cloth or applicator that may retain FLUOROPLEX Cream and avoid leaving any residues of FLUOROPLEX Cream on your hands, clothing, carpeting or furniture.

LABORATORY TESTS SECTION

Laboratory Tests: To rule out the presence of a frank neoplasm, a biopsy should be made of those areas failing to respond to treatment or recurring after treatment.

CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY SECTION

Carcinogenesis, mutagenesis, impairment of fertility: Adequate long-term studies in animals to evaluate carcinogenic potential have not been conducted with fluorouracil. In three in-vitro cell transformation assays, fluorouracil produced morphological transformation of cells. Morphological transformation was also produced in one of these in-vitro assays by a metabolite of fluorouracil and the transformed cells produced malignant tumors when injected into immunosuppressed syngeneic mice. Fluorouracil has been shown to exert mutagenic acitivity in the yeast cells, Bacillus subtilis and Drosophila assays. In addition, fluorouracil has produced chromosome damage at concentrations of 1.0 and 2.0 mcg/mL in an in vitro hamster fibroblast assay and increases in micronuclei formation in the bone marrow of mice at intraperitoneal doses within the human therapeutic dose range of 12-15 mg/kg/day. Patients receiving cumulative doses of 0.24-1.0 g of fluorouracil parenterally have shown an increase in numerical and structural chromosome aberrations in peripheral blood lymphocytes. Fluorouracil has been shown to impair fertility after parenteral administration in rats. In mice, single-dose intravenous and intraperitoneal injections of fluorouracil have been reported to kill differentiated spermatogonia and spermatocytes at a dose of 500 mg/kg and produce abnormalities in spermatids at 50 mg/kg.

Fluorouracil was negative in the dominant lethal mutation assay performed in mice.

PREGNANCY SECTION

TERATOGENIC EFFECTS SECTION

Pregnancy: Teratogenic effects: Fluorouracil may cause fetal harm when administered to a pregnant woman. Fluorouracil administered parenterally has been shown to be teratogenic in mice, rats and hamsters, and embryolethal in monkeys. Fluorouracil is contraindicated in women who are or may become pregnant. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus.

NURSING MOTHERS SECTION

Nursing mothers: It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, and because there is some systemic absorption of fluorouracil after topical administration (see PRECAUTIONS: General), mothers should not nurse their infants while receiving this drug.

PEDIATRIC USE SECTION

Pediatric use: Safety and effectiveness in pediatric patients have not been established.

ADVERSE REACTIONS

ADVERSE REACTIONS SECTION

Pain, pruritus, burning, irritation, inflammation, allergic contact dermatitis and telangiectasia have been reported. Occasionally, hyperpigmentation and scarring have also been reported.

OVERDOSAGE

OVERDOSAGE SECTION

Ordinarily, overdosage will not cause acute problems. If FLUOROPLEX Cream accidentally comes in contact with the eye(s), flush the eyes(s) with water or normal saline. If FLUOROPLEX Cream is accidentally ingested, induce emesis and gastric lavage. Administer symptomatic and supportive care as needed.

DOSAGE AND ADMINISTRATION

DOSAGE & ADMINISTRATION SECTION

The patient should be instructed to apply sufficient medication to cover the entire face or other affected areas.

Apply medication twice daily with fingertips and wash hands afterwards. A treatment period of 2-6 weeks is usually required.

Increasing the frequency of application and a longer period of administration with FLUOROPLEX Cream may be required on areas other than the head and neck.

When FLUOROPLEX Cream is applied to keratotic skin, a response occurs with the following sequence: erythema, usually followed by scaling, tenderness, erosion, ulceration, necrosis and re-epithelization. When the inflammatory reaction reaches the erosion, ulceration and necrosis stages, the use of the drug should be terminated. Responses may sometimes occur in areas which appear clinically normal. These may be sites of subclinical actinic (solar) keratosis which the medication is affecting.

HOW SUPPLIED

HOW SUPPLIED SECTION

FLUOROPLEX (fluorouracil) 1% Topical Cream is available in 30 g tubes (NDC 16110-812-30)

STORAGE AND HANDLING SECTION

NOTE: Avoid freezing. Store at 15° - 30°C (59° - 86°F) in tight containers.

Rx Only

REFERENCE

REFERENCES SECTION

Epstein E. Testing for 5-fluorouracil allergy: patch and intradermal tests. Contact Dermatitis 1984; 10:311.

SPL UNCLASSIFIED SECTION

Revised February 2022

ALMIRALL, LLC

^® Marks owned by Almirall, LLC
Manufactured by: Almirall, LLC
Exton, PA 19341, U.S.A.
Made in Germany

SPL PATIENT PACKAGE INSERT SECTION

This Patient Information has been approved by the U.S. Food and Drug Administration	Issued: February 2022
Patient Information FLUOROPLEX^®(FLOOR-oh-plex) (fluorouracil) 1% Topical Cream
Important: FLUOROPLEX Cream is for use on skin only (topical). Apply with care near the eyes, nose and mouth.
What is FLUOROPLEX Cream? FLUOROPLEX Cream is a prescription medicine used on the skin to treat multiple actinic (solar) keratosis. It is not known if FLUOROPLEX Cream is safe and effective in children.
Who should not use FLUOROPLEX Cream? Do not use FLUOROPLEX Cream if: you are pregnant or may become pregnant. FLUOROPLEX Cream may harm your unborn baby. Stop using FLUOROPLEX Cream and tell your healthcare provider right away if you become pregnant while using FLUOROPLEX Cream. you are allergic to any of the ingredients in FLUOROPLEX Cream. See the end of this leaflet for a list of ingredients in FLUOROPLEX Cream.
Before using FLUOROPLEX Cream, tell your healthcare provider about all of your medical conditions, including if you: are breastfeeding or plan to breastfeed. It is not known if FLUOROPLEX Cream passes into your breast milk. You should not breastfeed during treatment with FLUOROPLEX Cream.
How should I use FLUOROPLEX^® Topical Cream? Use FLUOROPLEX Cream exactly as your healthcare provider tells you. Your healthcare provider will tell you where to apply FLUOROPLEX Cream, how often and how long to apply it. FLUOROPLEX Cream is usually applied 2 times a day for 2 to 6 weeks. Use your fingertips to apply enough FLUOROPLEX Cream to cover the areas to be treated on your face or other affected areas, as instructed by your healthcare provider. Skin reactions are expected when you use FLUOROPLEX Cream. These skin reactions begin with redness, usually followed by dryness or tenderness and crusting of your skin. Before you see any healing of your skin, these skin reactions continue to progress. Stop using FLUOROPLEX Cream when you see raw areas (erosion and ulcers) and shedding of dead skin (sloughing). Be sure to follow your healthcare provider’s instructions about when to stop using FLUOROPLEX Cream. If your skin reaction bothers you or is severe, or if you are not sure what to do, call your healthcare provider for instructions. Avoid letting FLUOROPLEX Cream build up in the skin folds around your eyes, nose or mouth. Wash your hands right away after you apply FLUOROPLEX Cream. If you accidentally get FLUOROPLEX Cream in your eyes, flush your eyes with water or normal saline.
What should I avoid while using FLUOROPLEX Cream? Avoid covering the treated areas with an airtight dressing, unless your healthcare provider tells you to. Avoid sunlight and ultraviolet lights, such as sun lamps and tanning machines. FLUOROPLEX Cream can make your skin sensitive to light. You could get a severe sunburn. Do not breast feed or become pregnant while using FLUOROPLEX Cream. If you do become pregnant, stop using FLUOROPLEX Cream and tell your doctor right away. FLUOROPLEX Cream may be fatal to your pet if your pet licks or ingests FLUOROPLEX Cream. Avoid allowing pets to contact the FLUOROPLEX Cream container or your skin where you applied FLUOROPLEX Cream. Store FLUOROPLEX Cream out of reach of pets. Safely discard or clean any cloth or applicator that may have FLUOROPLEX Cream residue Avoid applying FLUOROPLEX Cream on your clothing, carpeting, or furniture. If your pet starts vomiting or starts having a seizure after your pet licks or ingests FLUOROPLEX Cream, seek immediate veterinary care for your pet.
What are the possible side effects of FLUOROPLEX Cream? Skin reactions including possible allergic reactions (allergic contact dermatitis). You may get skin reactions such as: pain itching burning irritation redness and swelling small blood vessels that can be seen under the skin darkening of the skin scarring Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of FLUOROPLEX Cream. For more information, ask your healthcare provider or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
How should I store FLUOROPLEX Cream? Do not freeze FLUOROPLEX Cream. Store FLUOROPLEX Cream between 59°F to 86°F (15°C to 30°C) in tight containers. Keep FLUOROPLEX Cream and all medicines out of the reach of children.
General Information about the safe and effective use of FLUOROPLEX Cream. Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use FLUOROPLEX Cream for a condition for which it was not prescribed. Do not give FLUOROPLEX Cream to other people, even if they have the same symptoms you have. It may harm them. You can ask your pharmacist or healthcare provider for information about FLUOROPLEX Cream that is written for the health professionals.
What are the ingredients in FLUOROPLEX Cream? Active ingredient: fluorouracil Inactive ingredients: benzyl alcohol, emulsifying wax, isopropyl myristate, mineral oil, purified water, and sodium hydroxide. ^® Marks owned by Almirall, LLC Manufactured by: Almirall, LLC, Exton, PA 19341 U.S.A. Made in Germany For more information, call 1-866-665-2782.

PRINCIPAL DISPLAY PANEL - 30 g Tube Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 16110-812-30

30 grams

Fluoroplex^®
(fluorouracil) 1%
Topical Cream

RX ONLY

CONTAINS:
Active: fluorouracil 1.0%
Inactives: benzyl alcohol; emulsifying wax; mineral oil; isopropyl myristate; sodium hydroxide; and purified water.

DOSAGE: Refer to accompanying literature for complete prescribing information.

Avoid freezing.

Store at 15° - 30°C (59° - 86°F).

SEE CRIMP FOR LOT NO. AND EXPIRATION DATE

Manufactured by: Almirall Hermal GmbH, 21465 Reinbek, Germany

Distributed by: Almirall, LLC, Exton, PA 19341, U.S.A.

Fluoroplex is a registered trademark of Almirall, LLC

ALMIRALL, LLC

PRINCIPAL DISPLAY PANEL - 30 g Carton Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 16110-812-30

30 grams

Fluoroplex^®
(fluorouracil) 1%
Topical Cream

Contains:
Active: fluorouracil 1.0%
Inactives: benzyl alcohol; emulsifying wax; mineral oil; isopropyl myristate; sodium hydroxide; and purified water.

Rx Only

Dosage: Refer to accompanying literature for complete prescribing information.

Avoid freezing.

Store at 15° - 30°C (59° - 86°F).

Manufactured by: Almirall Hermal GmbH, 21465 Reinbek, Germany

Distributed by: Almirall, LLC, Exton, PA 19341, U.S.A.

Fluoroplex is a registered trademark of Almirall, LLC

ALMIRALL, LLC

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
16110-812-30	2025-11-13	C162847	48780-1	1030e364-fb48-111a-e063-dadaa90a10e2	FLUOROPLEX (fluorouracil) 1% Topical Cream
16110-812-30	2024-01-30	C162847	48780-1	1030e364-fb48-111a-e063-dadaa90a10e2	FLUOROPLEX (fluorouracil) 1% Topical Cream

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
16110-812	FLUOROPLEX (FLUOROURACIL) CREAM [ALMIRALL, LLC]	9	Legacy NDC	20220318_258bb79a-56b3-4f46-ade6-7331ec031074.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
16110-812-30	GM - Gram	16110-812	da8b9fcc-7cd2-4c4a-8348-59906f645ee1	1	2013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
fluorouracil	ACTIVE INGREDIENT	U3P01618RT	1
fluorouracil	ACTIVE MOIETY	U3P01618RT	1
benzyl alcohol	INACTIVE INGREDIENT	LKG8494WBH	1
ISOPROPYL MYRISTATE	INACTIVE INGREDIENT	0RE8K4LNJS	1
mineral oil	INACTIVE INGREDIENT	T5L8T28FGP	1
sodium hydroxide	INACTIVE INGREDIENT	55X04QC32I	1
water	INACTIVE INGREDIENT	059QF0KO0R	1

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

Fluoroplex
fluorouracil
BENZYL ALCOHOL
ISOPROPYL MYRISTATE
MINERAL OIL
WATER
SODIUM HYDROXIDE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
16110-812	16110-812-30

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
FLUOROURACIL	U3P01618RT	ACTIB
BENZYL ALCOHOL	LKG8494WBH	IACT
ISOPROPYL MYRISTATE	0RE8K4LNJS	IACT
MINERAL OIL	T5L8T28FGP	IACT
WATER	059QF0KO0R	IACT
SODIUM HYDROXIDE	55X04QC32I	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 5 · 272 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
benzyl alcohol	BENZYL ALCOHOL	LKG8494WBH	INJECTION, SUSPENSION / INTRALESIONAL		20 mg	Exact identifier — unii candidate 50 equally ranked IID candidates
ISOPROPYL MYRISTATE	ISOPROPYL MYRISTATE	0RE8K4LNJS	SUSPENSION / AURICULAR (OTIC)	0.02 %w/w		Exact identifier — unii candidate 18 equally ranked IID candidates
benzyl alcohol	BENZYL ALCOHOL	LKG8494WBH	INJECTION, EMULSION / SUBCUTANEOUS		225 mg	Exact identifier — unii candidate 50 equally ranked IID candidates
sodium hydroxide	SODIUM HYDROXIDE	55X04QC32I	SUSPENSION / ORAL	400 mg		Exact identifier — unii candidate 174 equally ranked IID candidates
sodium hydroxide	SODIUM HYDROXIDE	55X04QC32I	GEL / TRANSDERMAL		472 mg	Exact identifier — unii candidate 174 equally ranked IID candidates
sodium hydroxide	SODIUM HYDROXIDE	55X04QC32I	INJECTION, POWDER, FOR SOLUTION / PARENTERAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
sodium hydroxide	SODIUM HYDROXIDE	55X04QC32I	SOLUTION / INTRATHECAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
benzyl alcohol	BENZYL ALCOHOL	LKG8494WBH	INJECTION / INTRALESIONAL		23 mg	Exact identifier — unii candidate 50 equally ranked IID candidates
sodium hydroxide	SODIUM HYDROXIDE	55X04QC32I	INJECTION / INTRAPLEURAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
sodium hydroxide	SODIUM HYDROXIDE	55X04QC32I	INJECTION / INTRATHECAL	176 mg		Exact identifier — unii candidate 174 equally ranked IID candidates
mineral oil	MINERAL OIL	T5L8T28FGP	SUSPENSION / TOPICAL	82 %w/w		Exact identifier — unii candidate 30 equally ranked IID candidates
sodium hydroxide	SODIUM HYDROXIDE	55X04QC32I	INJECTION / INTRACAUDAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
sodium hydroxide	SODIUM HYDROXIDE	55X04QC32I	INJECTION / INTRACARDIAC	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
mineral oil	MINERAL OIL	T5L8T28FGP	TABLET, DELAYED RELEASE / ORAL	5.67 mg		Exact identifier — unii candidate 30 equally ranked IID candidates
sodium hydroxide	SODIUM HYDROXIDE	55X04QC32I	INJECTION, SOLUTION / SUBCUTANEOUS	1 %w/v		Exact identifier — unii candidate 174 equally ranked IID candidates
sodium hydroxide	SODIUM HYDROXIDE	55X04QC32I	SOLUTION / PERIODONTAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
benzyl alcohol	BENZYL ALCOHOL	LKG8494WBH	INJECTION / INTRAVENOUS		1620 mg	Exact identifier — unii candidate 50 equally ranked IID candidates
benzyl alcohol	BENZYL ALCOHOL	LKG8494WBH	INJECTION / ENDOTRACHEAL		54 mg	Exact identifier — unii candidate 50 equally ranked IID candidates
ISOPROPYL MYRISTATE	ISOPROPYL MYRISTATE	0RE8K4LNJS	AEROSOL, SPRAY / TOPICAL	6.89 %w/w		Exact identifier — unii candidate 18 equally ranked IID candidates
sodium hydroxide	SODIUM HYDROXIDE	55X04QC32I	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / PARENTERAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
mineral oil	MINERAL OIL	T5L8T28FGP	OIL / TOPICAL	43.29 %v/v		Exact identifier — unii candidate 30 equally ranked IID candidates
mineral oil	MINERAL OIL	T5L8T28FGP	CREAM / VAGINAL		402 mg	Exact identifier — unii candidate 30 equally ranked IID candidates
ISOPROPYL MYRISTATE	ISOPROPYL MYRISTATE	0RE8K4LNJS	FILM, EXTENDED RELEASE / TRANSDERMAL	20.4 mg		Exact identifier — unii candidate 18 equally ranked IID candidates
sodium hydroxide	SODIUM HYDROXIDE	55X04QC32I	FILM, SOLUBLE / BUCCAL		5 mg	Exact identifier — unii candidate 174 equally ranked IID candidates
sodium hydroxide	SODIUM HYDROXIDE	55X04QC32I	LIQUID / INTRAVENOUS	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
sodium hydroxide	SODIUM HYDROXIDE	55X04QC32I	INJECTION / INTRAVENOUS		456 mg	Exact identifier — unii candidate 174 equally ranked IID candidates
sodium hydroxide	SODIUM HYDROXIDE	55X04QC32I	INJECTABLE, LIPOSOMAL / INTRAVENOUS	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
benzyl alcohol	BENZYL ALCOHOL	LKG8494WBH	INJECTION, EMULSION / INTRAVENOUS		45 mg	Exact identifier — unii candidate 50 equally ranked IID candidates
sodium hydroxide	SODIUM HYDROXIDE	55X04QC32I	INJECTION, POWDER, FOR SOLUTION / RECTAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
sodium hydroxide	SODIUM HYDROXIDE	55X04QC32I	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRA-ARTERIAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
sodium hydroxide	SODIUM HYDROXIDE	55X04QC32I	LIQUID / ORAL	2 mg/5ml		Exact identifier — unii candidate 174 equally ranked IID candidates
sodium hydroxide	SODIUM HYDROXIDE	55X04QC32I	ELIXIR / ORAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
mineral oil	MINERAL OIL	T5L8T28FGP	OINTMENT / AURICULAR (OTIC)	NA		Exact identifier — unii candidate 30 equally ranked IID candidates
sodium hydroxide	SODIUM HYDROXIDE	55X04QC32I	SOLUTION/ DROPS / OPHTHALMIC	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
sodium hydroxide	SODIUM HYDROXIDE	55X04QC32I	POWDER, FOR SUSPENSION / ORAL		9 mg	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
mineral oil	MINERAL OIL	T5L8T28FGP	SPRAY / TOPICAL		1379 mg	Exact identifier — unii candidate 30 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	CONCENTRATE / ORAL	10 mg/5ml		Exact identifier — unii candidate 174 equally ranked IID candidates
sodium hydroxide	SODIUM HYDROXIDE	55X04QC32I	SOLUTION / INTRAVASCULAR	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
sodium hydroxide	SODIUM HYDROXIDE	55X04QC32I	INJECTION, SOLUTION / SUBMUCOSAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
sodium hydroxide	SODIUM HYDROXIDE	55X04QC32I	INJECTION, SOLUTION / INTRAVENOUS		78 mg	Exact identifier — unii candidate 174 equally ranked IID candidates
benzyl alcohol	BENZYL ALCOHOL	LKG8494WBH	INJECTION / INTRA-ARTERIAL	0.9 %w/v		Exact identifier — unii candidate 50 equally ranked IID candidates
benzyl alcohol	BENZYL ALCOHOL	LKG8494WBH	SOLUTION / INTRAVENOUS		242 mg	Exact identifier — unii candidate 50 equally ranked IID candidates
sodium hydroxide	SODIUM HYDROXIDE	55X04QC32I	INJECTION / INTRAMUSCULAR	176 mg		Exact identifier — unii candidate 174 equally ranked IID candidates
mineral oil	MINERAL OIL	T5L8T28FGP	TABLET, EXTENDED RELEASE / ORAL	NA		Exact identifier — unii candidate 30 equally ranked IID candidates
sodium hydroxide	SODIUM HYDROXIDE	55X04QC32I	INJECTION / PERIDURAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
sodium hydroxide	SODIUM HYDROXIDE	55X04QC32I	INJECTION / SUBCONJUNCTIVAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
sodium hydroxide	SODIUM HYDROXIDE	55X04QC32I	INJECTION / INTRASPINAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
sodium hydroxide	SODIUM HYDROXIDE	55X04QC32I	INJECTION / RETROBULBAR	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
ISOPROPYL MYRISTATE	ISOPROPYL MYRISTATE	0RE8K4LNJS	GEL / TRANSDERMAL		85 mg	Exact identifier — unii candidate 18 equally ranked IID candidates
sodium hydroxide	SODIUM HYDROXIDE	55X04QC32I	SOLUTION / IONTOPHORESIS	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
sodium hydroxide	SODIUM HYDROXIDE	55X04QC32I	INJECTION, SOLUTION / EPIDURAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
sodium hydroxide	SODIUM HYDROXIDE	55X04QC32I	TABLET, EXTENDED RELEASE / ORAL		13 mg	Exact identifier — unii candidate 174 equally ranked IID candidates
sodium hydroxide	SODIUM HYDROXIDE	55X04QC32I	INJECTION / INTRADERMAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
sodium hydroxide	SODIUM HYDROXIDE	55X04QC32I	GEL / VAGINAL		20 mg	Exact identifier — unii candidate 174 equally ranked IID candidates
sodium hydroxide	SODIUM HYDROXIDE	55X04QC32I	JELLY / TOPICAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
sodium hydroxide	SODIUM HYDROXIDE	55X04QC32I	POWDER / INTRAVENOUS	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
ISOPROPYL MYRISTATE	ISOPROPYL MYRISTATE	0RE8K4LNJS	GEL, METERED / TRANSDERMAL		50 mg	Exact identifier — unii candidate 18 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
N016988-001	FLUOROPLEX	FLUOROURACIL	1%	CREAM / TOPICAL		RLD, Approved before 1982

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	RLD / RS	Source SHA-256
2026-09-14 22:38:34	2026-08	N016988-001	FLUOROPLEX	1%	CREAM / TOPICAL	RLD, Approved before 1982	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N016988-001	FLUOROPLEX	1%	CREAM / TOPICAL	RLD, Approved before 1982	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N016988-001	FLUOROPLEX	1%	CREAM / TOPICAL	RLD, Approved before 1982	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N016988-001	FLUOROPLEX	1%	CREAM / TOPICAL	RLD, Approved before 1982	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N016988-001	FLUOROPLEX	1%	CREAM / TOPICAL	RLD, Approved before 1982	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N016988-001	FLUOROPLEX	1%	CREAM / TOPICAL	RLD, Approved before 1982	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N016988-001	FLUOROPLEX	1%	CREAM / TOPICAL	RLD, Approved before 1982	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N016988-001	FLUOROPLEX	1%	CREAM / TOPICAL	RLD, Approved before 1982	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N016988-001	FLUOROPLEX	1%	CREAM / TOPICAL	RLD, Approved before 1982	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N016988-001	FLUOROPLEX	1%	CREAM / TOPICAL	RLD, Approved before 1982	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N016988-001	FLUOROPLEX	1%	CREAM / TOPICAL	RLD, Approved before 1982	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N016988-001	FLUOROPLEX	1%	CREAM / TOPICAL	RLD, Approved before 1982	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N016988-001	FLUOROPLEX	1%	CREAM / TOPICAL	RLD, Approved before 1982	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N016988-001	FLUOROPLEX	1%	CREAM / TOPICAL	RLD, Approved before 1982	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N016988-001	FLUOROPLEX	1%	CREAM / TOPICAL	RLD, Approved before 1982	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N016988-001	FLUOROPLEX	1%	CREAM / TOPICAL	RLD, Approved before 1982	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N016988-001	FLUOROPLEX	1%	CREAM / TOPICAL	RLD, Approved before 1982	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N016988-001	FLUOROPLEX	1%	CREAM / TOPICAL	RLD, Approved before 1982	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N016988-001	FLUOROPLEX	1%	CREAM / TOPICAL	RLD, Approved before 1982	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N016988-001	FLUOROPLEX	1%	CREAM / TOPICAL	RLD, RS, Approved before 1982	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N016988-001	FLUOROPLEX	1%	CREAM / TOPICAL	RLD, Approved before 1982	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N016988-001	FLUOROPLEX	1%	CREAM / TOPICAL	RLD, Approved before 1982	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N016988-001	FLUOROPLEX	1%	CREAM / TOPICAL	RLD, RS, Approved before 1982	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N016988-001	FLUOROPLEX	1%	CREAM / TOPICAL	RLD, RS, Approved before 1982	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N016988-001	FLUOROPLEX	1%	CREAM / TOPICAL	RLD, RS, Approved before 1982	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N016988-001	FLUOROPLEX	1%	CREAM / TOPICAL	RLD, RS, Approved before 1982	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N016988-001	FLUOROPLEX	1%	CREAM / TOPICAL	RLD, RS, Approved before 1982	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N016988-001	FLUOROPLEX	1%	CREAM / TOPICAL	RLD, RS, Approved before 1982	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N016988-001	FLUOROPLEX	1%	CREAM / TOPICAL	RLD, RS, Approved before 1982	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N016988-001	FLUOROPLEX	1%	CREAM / TOPICAL	RLD, Approved before 1982	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N016988-001	FLUOROPLEX	1%	CREAM / TOPICAL	RLD, Approved before 1982	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N016988-001	FLUOROPLEX	1%	CREAM / TOPICAL	RLD, Approved before 1982	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N016988-001	FLUOROPLEX	1%	CREAM / TOPICAL	RLD, Approved before 1982	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N016988-001	FLUOROPLEX	1%	CREAM / TOPICAL	RLD, Approved before 1982	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N016988-001	FLUOROPLEX	1%	CREAM / TOPICAL	RLD, Approved before 1982	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N016988-001	FLUOROPLEX	1%	CREAM / TOPICAL	RLD, Approved before 1982	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N016988-001	FLUOROPLEX	1%	CREAM / TOPICAL	RLD, Approved before 1982	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N016988-001	FLUOROPLEX	1%	CREAM / TOPICAL	RLD, Approved before 1982	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N016988-001	FLUOROPLEX	1%	CREAM / TOPICAL	RLD, Approved before 1982	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N016988-001	FLUOROPLEX	1%	CREAM / TOPICAL	RLD, Approved before 1982	`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
666ba32e-8b9d-4828-ace9-cc7dab541736			258bb79a-56b3-4f46-ade6-7331ec031074	2025-10-28	Warnings, Adverse reactions	Exact identifier spl set id: 258bb79a-56b3-4f46-ade6-7331ec031074

Reported adverse events (FAERS/openFDA)#

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