Prescription drug · UNAPPROVED DRUG OTHER
Lidothol ES (Menthol 5%, lidocaine 4%) NDC 80425-0561
Lidocaine .04 g/g; Menthol .05 g/g · System · Transdermal · Advanced Rx of Tennessee, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 80425-0561-1 | 8042505610180425056101 | 15 POUCH in 1 BOX (80425-0561-1) / 1 PATCH in 1 POUCH / 1.38 g in 1 PATCHMarketed from Feb 2, 2026 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Lidothol ES
- Generic name (nonproprietary)
- menthol 5%, lidocaine 4%
- Dosage form
- System
- Route
- Transdermal
- Labeler
- Advanced Rx of Tennessee, LLCNDC labeler code 80425
- Product type
- Prescription drug
- Marketing category
- Unapproved drug (other)
- Marketing start
- Listing expires
- Other FDA classes
- Amides (Chemical structure)Local Anesthesia (Physiologic effect)
- Identifiers
- Product ID 80425-0561_52baed50-3fef-4dd2-e063-6294a90a56feSPL ID 52baed50-3fef-4dd2-e063-6294a90a56feSPL set ID 49ef3680-e34e-1fe7-e063-6294a90a959fRxCUI 1552201UNII 98PI200987, L7T10EIP3A
- Pharmacologic class
- Amide Local Anesthetic; Antiarrhythmic
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Transdermal products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N480425056101followed by a unit qualifier and the quantityPackage 80425-0561-01. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
INDICATIONS AND USAGE Lidothol® ES is a formulation used to assist patients in the treatment of mild to moderate acute or chronic aches or pain. Muscle or joint pain can be due to muscle or ligament strains, simple backache, tendonitis, osteoarthritis, rheumatoid arthritis, peripheral neuropathies such as diabetic neuropathy or post-herpetic neuralgia, and other complex regional pains. It can also be used to help with certain types of headaches, but use with caution when applying in order to avoid eye contact. Other uses may be considered if deemed clinically relevant.
Excerpt only. Read the full label for complete information.
About NDC 80425-0561
- What is NDC 80425-0561?
- 80425-0561 is the product NDC for Lidothol ES, Lidocaine .04 g/g; Menthol .05 g/g system, listed with the FDA by Advanced Rx of Tennessee, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Lidothol ES (Menthol 5%, lidocaine 4%).
- What is the active ingredient?
- Lidocaine, Menthol.
- Who is the labeler?
- Advanced Rx of Tennessee, LLC, NDC labeler code 80425. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Lidothol ES?
- 2 other product NDCs are listed under this name. See all Lidothol ES NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Lidothol ES products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Lidothol ESmenthol 5%, lidocaine 4% | Lidocaine .04 g/g; Menthol .05 g/g | SystemTransdermal | Clinic Pharma | 83881-445 | 83881-0445-15 |
| Lidothol ESmenthol 5%, lidocaine 4% | Lidocaine .04 g/g; Menthol .05 g/g | SystemTransdermal | ASCLEMED USA INC. | 87063-323 | 87063-0323-15 |