Prescription drug · UNAPPROVED DRUG OTHER
Lidothol (Lidocaine hcl, menthol) NDC 80425-0516
Menthol 5 g/100g; Lidocaine hydrochloride 4.5 g/100g · Gel · Cutaneous · Advanced Rx of Tennessee, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 80425-0516-1 | 8042505160180425051601 | 1 TUBE in 1 BOX (80425-0516-1) / 99.2 g in 1 TUBEMarketed from May 5, 2025 |
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
- Generic name (nonproprietary)
- lidocaine hcl, menthol
- Active ingredients
- Menthol — 5 g/100gLidocaine hydrochloride — 4.5 g/100g
- Dosage form
- Gel
- Route
- Cutaneous
- 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 80425-0516_3467f4f8-72ee-4446-e063-6294a90a80c0SPL ID 3467f4f8-72ee-4446-e063-6294a90a80c0SPL set ID 3467f4c7-122c-40df-e063-6394a90ae36eRxCUI 2257313UNII L7T10EIP3A, V13007Z41A
- 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 drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.
- NDC on a medical claim
N480425051601followed by a unit qualifier and the quantityPackage 80425-0516-01. 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)
INDICATION AND USAGE Lidothol Gel is indicated for relief of pain associated with arthritis, backache, cramps, discomfort, neckache, soreness, sprains, strains. It should be applied only to intact skin.
Excerpt only. Read the full label for complete information.
About NDC 80425-0516
- What is NDC 80425-0516?
- 80425-0516 is the product NDC for Lidothol, Menthol 5 g/100g; Lidocaine hydrochloride 4.5 g/100g gel, 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 (LIDOCAINE HCl, MENTHOL).
- What is the active ingredient?
- Menthol, Lidocaine hydrochloride.
- 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?
- 4 other product NDCs are listed under this name. See all Lidothol NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Lidothol products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Lidothollidocaine hcl, menthol | Menthol 5 g/100g; Lidocaine hydrochloride 4.5 g/100g | GelCutaneous | Clinic Pharma | 83881-455 | 83881-0455-35 |
| Lidothollidocaine hcl, menthol | Menthol 5 g/100g; Lidocaine hydrochloride 4.5 g/100g | GelCutaneous | ASCLEMED USA INC. | 87063-218 | 87063-0218-99 |
| Lidothollidocaine and menthol | Menthol 1 mg/100mg; Lidocaine 4 mg/100mg | PatchTopical | Advanced Rx Pharmacy of Tennessee, LLC | 80425-0385 | 80425-0385-01 |
| Lidothollidocaine hcl, menthol | Menthol 5 g/100g; Lidocaine hydrochloride 4.5 g/100g | GelTopical | Asclemed USA, Inc. | 76420-253 | 76420-0253-04 |