Quick answers
- What is Diclofenac epolamine used for?
- The FDA-approved label (Flector, IBSA Pharma Inc., October 21, 2025) says: “FLECTOR ® is indicated for the topical treatment of acute pain due to minor strains, sprains, and contusions in adults and pediatric patients 6 years and older. FLECTOR is a nonsteroidal anti-inflammatory drug (NSAID) and is indicated for the topical treatment of acute pain due to minor strains, sprains, and contusions in adults and pediatric patients 6 years and older.” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Diclofenac epolamine have a boxed warning?
- Yes. The FDA label for Flector has a boxed warning, the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
- Is there a shortage of Diclofenac epolamine?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Diclofenac epolamine been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Diclofenac epolamine?
- 13 companies list prescription products of Diclofenac epolamine in the FDA NDC Directory, including IBSA Pharma Inc., Asclemed USA, Inc. and Acertis Pharmaceuticals, LLC.
What Diclofenac epolamine is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
FLECTOR ® is indicated for the topical treatment of acute pain due to minor strains, sprains, and contusions in adults and pediatric patients 6 years and older. FLECTOR is a nonsteroidal anti-inflammatory drug (NSAID) and is indicated for the topical treatment of acute pain due to minor strains, sprains, and contusions in adults and pediatric patients 6 years and older.
— FDA label: Flector, IBSA Pharma Inc., effective October 21, 2025. Read the full label on DailyMed →
The FDA has 14 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
This label has a boxed warning. Read it on the full label →
14 of 14 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | System |
|---|---|
| Route | Topical |
| Prescription products | 15 in the FDA NDC Directory |
| Brand names | Licart, Flector, Diclox Patch 30ct |
What pharmacies pay (NADAC)
The National Average Drug Acquisition Cost (NADAC) is the average price U.S. retail pharmacies paid to buy one unit of a medicine (one tablet, one mL or one gram), from a monthly survey of pharmacy invoices by the Centers for Medicare & Medicaid Services (CMS). State Medicaid programs use it to pay pharmacies.
This is not the price you pay. What you pay depends on your insurance (copay or coinsurance), your pharmacy and any discounts, and pharmacies also charge for filling a prescription. Ask your pharmacist or your health plan what your price will be.
| Strength and form | Generic or brand | Pharmacies pay |
|---|---|---|
| diclofenac epolamine 0.013 g system | Generic | $4.63 per unit |
NADAC list of November 4, 2026; these prices took effect on October 21, 2026. Shown only where a package’s NDC code matches the NADAC list exactly, and only for that exact strength and form: nothing is averaged across strengths. Strengths and forms not listed here have no NADAC price.
Source: NADAC (National Average Drug Acquisition Cost) 2026, data.medicaid.gov (CMS) →
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- IBSA Pharma Inc.2 products
- Asclemed USA, Inc.2 products
- Acertis Pharmaceuticals, LLC1 product
- Advanced Rx Pharmacy of Tennessee, LLC1 product
- Preferred Pharmaceuticals Inc.1 product
- Hawaii Repack, Inc.1 product
- Phoenix RX LLC1 product
- Sportpharm LLC1 product
- Advanced Rx of Tennessee, LLC1 product
- Quality Care Products, LLC1 product
- Injecta Medcial LLC1 product
- YARAL Pharma Inc.1 product
- Teva Pharmaceuticals USA, Inc.1 product
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA021234 FLECTOR | Ibsa | January 31, 2007 | 15, latest November 21, 2024 2024: Labeling · 2021: Labeling · 2019: Labeling |
| NDA206976 LICART | Ibsa Inst Bio | December 19, 2018 | 6, latest March 27, 2026 2026: Efficacy · 2024: Labeling · 2024: Manufacturing (CMC) |
Shortage status
The FDA drug shortage list does not show these products.
Recalls
No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.
Official identifiers
| RxCUI (RxNorm) | 855626, 855628, 2372911, 2385117 |
|---|---|
| SPL set ID of the quoted label | 1f19a016-c4fc-43c5-9990-e5f2e2776a82 |
| FDA labels (SPL) | 14 |
| FDA applications | NDA021234, NDA206976 |
| Active ingredients (FDA) | DICLOFENAC EPOLAMINE |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Flector, IBSA Pharma Inc., effective October 21, 2025; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →