Prescription drug · UNAPPROVED DRUG OTHER
Diclona (Lidocaine 4.5%, diclofenac 1%) NDC 80425-0517
Diclofenac sodium .01 g/g; Lidocaine .045 g/g · Gel · Cutaneous · Advanced Rx of Tennessee, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 80425-0517-1 | 80425051701 | 99 g in 1 TUBE (80425-0517-1)Marketed 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)
- Diclona
- Generic name (nonproprietary)
- lidocaine 4.5%, diclofenac 1%
- Active ingredients
- Diclofenac sodium — .01 g/gLidocaine — .045 g/g
- 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)Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)Decreased Prostaglandin Production (Physiologic effect)Local Anesthesia (Physiologic effect)
- Identifiers
- Product ID 80425-0517_346855a0-df4e-6369-e063-6394a90a0737SPL ID 346855a0-df4e-6369-e063-6394a90a0737SPL set ID 34685ef2-0015-8941-e063-6294a90ad0f7RxCUI 2600049UNII QTG126297Q, 98PI200987
- Pharmacologic class
- Amide Local Anesthetic; Antiarrhythmic; Nonsteroidal Anti-inflammatory Drug
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
N480425051701followed by a unit qualifier and the quantityPackage 80425-0517-01. 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 Diclona™ is indicated for relief of pain associated with arthritis, backache, cramps, discomfort, neckache, soreness, sprains, strains. It should be applied only to intact skin. Sun avoidance is indicated during therapy.
Excerpt only. Read the full label for complete information.
About NDC 80425-0517
- What is NDC 80425-0517?
- 80425-0517 is the product NDC for Diclona, Diclofenac sodium .01 g/g; Lidocaine .045 g/g 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?
- Diclona (Lidocaine 4.5%, Diclofenac 1%).
- What is the active ingredient?
- Diclofenac sodium, Lidocaine.
- 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 Diclona?
- 2 other product NDCs are listed under this name. See all Diclona NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Diclona products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Diclonalidocaine 4.5%, diclofenac 1% | Diclofenac sodium .01 g/g; Lidocaine .045 g/g | GelCutaneous | Preferred Pharmaceuticals Inc. | 68788-4013 | 68788-4013-09 |
| Diclonalidocaine 4.5%, diclofenac 1% | Diclofenac sodium .01 g/g; Lidocaine .045 g/g | GelCutaneous | Clinic Pharma | 83881-102 | 83881-0102-35 |