Over-the-counter drug · OTC MONOGRAPH DRUG
PUREGEN LABS Pain Relief 4 Lidocaine (Lidocaine) NDC 80513-814
Lidocaine 40 mg/g · Patch · Topical · Advanced Rx LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 80513-814-30 | 80513081430 | 30 PATCH in 1 BOX (80513-814-30) / 12 g in 1 PATCHMarketed from Jun 3, 2024 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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)
- PUREGEN LABS Pain Relief 4 Lidocaine
- Generic name (nonproprietary)
- lidocaine
- Active ingredients
- Lidocaine — 40 mg/g
- Dosage form
- Patch
- Route
- Topical
- Labeler
- Advanced Rx LLCNDC labeler code 80513
- Product type
- Over-the-counter drug
- Marketing category
- OTC monograph drugApplication M 017
- Marketing start
- Listing expires
- Other FDA classes
- Amides (Chemical structure)Local Anesthesia (Physiologic effect)
- Identifiers
- Product ID 80513-814_1a99684d-b57c-8eac-e063-6294a90aae2eSPL ID 1a99684d-b57c-8eac-e063-6294a90aae2eSPL set ID 9dff40d8-8d7e-4629-bea5-987f5e68477dRxCUI 1737778UNII 98PI200987UPC 0380513001122
- 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. Topical products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N480513081430followed by a unit qualifier and the quantityPackage 80513-0814-30. 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)
Uses: For the temporary relief of pain.
Excerpt only. Read the full label for complete information.
About NDC 80513-814
- What is NDC 80513-814?
- 80513-814 is the product NDC for PUREGEN LABS Pain Relief 4 Lidocaine, Lidocaine 40 mg/g patch, listed with the FDA by Advanced Rx LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- PUREGEN LABS Pain Relief 4 Lidocaine (Lidocaine).
- What is the active ingredient?
- Lidocaine.
- Who is the labeler?
- Advanced Rx LLC, NDC labeler code 80513. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for PUREGEN LABS Pain Relief 4 Lidocaine?
- None: this is the only finished product listed under this name.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Other NDCs under M 017
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| 0.5% Lidocaine Burn Relieflidocaine hydrochloride | Lidocaine hydrochloride .5 g/100g | GelTopical | Nantong Health & Beyond Hygienic Products Inc. | 43473-099 |
| 0.5% Lidocaine Burn Relieflidocaine hydrochloride | Lidocaine hydrochloride .5 g/100g | GelTopical | Universal Distribution Center LLC | 52000-437 |
| 1% Hydrocortisone Anti-itch | Hydrocortisone 10 mg/g | CreamTopical | ALAINA HEALTHCARE PRIVATE LIMITED | 73492-291 |
| 10% Methyl Salicylate Pain Relief Patch10% methyl salicylate | Methyl salicylate 10 mg/100mg | TapeTopical | Akron Coating & Adhesives | 65604-222 |
| 11681168 burn spray | Lidocaine hydrochloride .02 mg/mL | SprayTopical | Dynarex Corporation | 67777-013 |
| 2.0% Lidocaine Burnlidocaine hydrochloride | Lidocaine hydrochloride 2 g/100mL | SprayTopical | Nantong Health & Beyond Hygienic Products Inc. | 43473-097 |
| 2.0% Lidocaine Burnlidocaine hydrochloride | Lidocaine hydrochloride 2 g/100mL | SprayTopical | Universal Distribution Center LLC | 52000-441 |
| 2.5% Menthol PAIN RELIEFmenthol | Menthol, Unspecified form 25 mg/g | GelTopical | Nantong Health & Beyond Hygienic Products Inc. | 43473-096 |
| 2.5% Menthol PAIN RELIEFmenthol | Menthol, Unspecified form 25 mg/g | GelTopical | Universal Distribution Center LLC | 52000-440 |
| 24 7 Relief and Recovery Pain Relievingmenthol, unspecified form | Menthol, Unspecified form 37 mg/mL | CreamTopical | Triplicare Inc | 87656-964 |
| 2677 First Aid Burn Cream | Benzalkonium chloride 13 mg/10000mg; Lidocaine hydrochloride 50 mg/10000mg | CreamTopical | ProStat First Aid LLC | 58228-2677 |
| 2nd CHANCE MOBILITY Pain Reliefhistamine dihydrochloride | Histamine dihydrochloride .5 mg/g | CreamTopical | ALPHA NUTRITION, LLC | 83984-441 |
| 365 Medicated Lip Balmmedicated lip balm | Camphor (Natural) .0578 g/4.25g | StickTopical | Whole Foods Market, Inc. | 42681-0001 |
| 3X Medicated Toothache and Gum Gelbenzocaine | Benzocaine 20 g/100g + 2 more ingredients | GelOral | Rite Aid | 11822-0613 |
| 4 Lidocaine Topical Anestheticlidocaine | Lidocaine 40 mg/g | CreamTopical | RUGBY LABORATORIES | 0536-1267 |
| 4% Lidocaine Maximum Strength Pain Relieflidocaine | Lidocaine .04 g/1 | PatchTopical | Shenzhen Finona Information Technology Co., Ltd | 85839-011 |
| 4% Lidocaine Pain Relief Patchlidocaine 4% | Lidocaine .04 g/1 | PatchTransdermal | Guangxi Keyun E-commerce Co., Ltd. | 87278-003 |
| 4% Lidocaine Pain Relief Patchlidocaine 4% | Lidocaine .04 g/1 | PatchTransdermal | Guangxi Keyun E-commerce Co., Ltd. | 87278-020 |
| 4% Lidocaine Patches4% lidocaine | Lidocaine 40 mg/1 | PatchTopical | Shenzhen Huayuan Hengsheng Technology Co., Ltd. | 87394-002 |
| 4% Lidocaine Patches | Lidocaine 4 g/1001 | PatchTopical | Shenzhen Chaoxiji Technology Co.,Ltd. | 87794-006 |
Showing 20 of 40.